See more: clinical oncology

Demonstrates specialized knowledge of the unique needs of oncology patients undergoing treatment on cancer trials.
Working knowledge of chemotherapy administration.
Have personal qualities and interpersonal communication skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances.
Detail oriented and teamwork skills required.
Must be motivated, organized able to perform multiple tasks in a timely manner and work efficiently under pressure.
Demonstrates the ability to manage multiple clinical trials and function independently.
Critical thinker and possesses an analytical approach to problem solving.
Able to perform diverse clinical and clerical duties.
Possesses a working knowledge of Microsoft Office applications of Word, Excel, Access, Outlook, and Internet skills.

See more: clinical oncology

More info about clinical oncology

See more: clinical oncology

Demonstrates specialized knowledge of the unique needs of oncology patients undergoing treatment on cancer trials.
Working knowledge of chemotherapy administration.
Have personal qualities and interpersonal communication skills to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances.
Detail oriented and teamwork skills required.
Must be motivated, organized able to perform multiple tasks in a timely manner and work efficiently under pressure.
Demonstrates the ability to manage multiple clinical trials and function independently.
Critical thinker and possesses an analytical approach to problem solving.
Able to perform diverse clinical and clerical duties.
Possesses a working knowledge of Microsoft Office applications of Word, Excel, Access, Outlook, and Internet skills.

More info about clinical oncology

Job Summary: Here is a multi-national principle pharmaceutical that needs a Senior Clinical Project Manager (PM) to work in their highly proficient cardiovascular Oncology department.
Requirements: They are searching for a confident and ambitious Senior Project Manager with the ability to manage an inspiring team and deadlines.


Your responsibilities will entail project management from CRO Selection / management, protocol writing for
exciting therapeutic areas, flexible working hours.

You will be working on 2 large scale studies within cardiovascular oncology. You will be involved from study feasibility also.

The successful candidate will have a minimum of 4yrs Clinical Project Manager experience a life science degree and stable career history. This is an impressive company and a challenging role and if you think you have the right skills for it, please send us your cv so we can start interviewing immediately.

This is an outstanding opportunity to work with a respected and recognised global brand. A chance to progress your career and work with a passionate team. The company is recognised as paying superb pkgs. to their Clinical Project Manager team.

I am the sole agent looking after this requirement. Please send your CV for immediate response to minesh.ghelani@skillsalliance.co.

See more: clinical oncology

If someone you're caring for suffers from advanced prostate cancer, chances are the news you've been hearing isn't good. Once prostate cancer starts to spread, it's difficult to treat, and the prognosis often isn't encouraging. In the past few weeks, though, there's been all sorts of excitement about new drugs and treatment options. They're still being studied, but there's good news about that, too. It means they're available through clinical trials (often for free) and these trials are being held all over the country.
If the idea of joining a clinical trial seems intimidating, that's a common reaction. But here's everything you need to know to get started.

See more: clinical oncology

MONTREAL, July 31 Aegera Therapeutics Inc. is pleased
to announce the dosing of the first patient in a fifth phase 1 and 2
clinical oncology study of AEG35156, a second generation antisense
therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis
protein family.
The study, made possible, in part, by funding from The Leukemia
Lymphoma Society, is entitled A Phase 1-2, Multicenter, Open-Label Study
of the X- Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in
Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia, Small
Lymphocytic Lymphoma and Follicular Lymphoma. It is being conducted at the
Princess Margaret Hospital (PMH) located in Toronto, Ontario, and is led by
Principal Investigator Dr. Christine Chen, with co-Principal Investigators
Dr. Aaron Schimmer and Dr. Joe Brandwein, all from the PMHs Department of
Hematology and Oncology.
The primary objective of this study is to determine the recommended
dose of AEG35156 in patients with relapsed or refractory chronic
lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular
lymphoma (FL), and to determine the safety profile and response rate to
AEG35156 in these patient populations.
Preliminary evidence of activity in lymphoma was observed in phase 1
studies with AEG35156, stated Dr. Jacques Jolivet, Aegeras VP Clinical.
This clinical trial will specifically study the role played by XIAP
knockdown in inducing antitumor activity in CLL, SLL and FL.Our clinical program around AEG35156 continues to expand and broaden
as we seek to move this therapeutic forward to approval, added Aegeras
President and Chief Executive Officer, Dr. Michael J. Berendt. By adding
these lymphoma indications to AEG35156s ongoing phase 1 and 2 studies in
leukemia (AML), pancreatic, breast, and non-small cell lung cancer, we
continue to seek to position AEG35156 as an important therapeutic option
that could address important unmet medical needs across a spectrum of
cancer indications. I must also thank, once again, The Leukemia Lymphoma
Society for their financial support of this study which is the first
funding granted for a clinical trial under their new Therapy Acceleration
Program.
The Leukemia Lymphoma Society Canada (LLSC) National Board Chairman,
Robert Rollwagen, added, The initiation of patient enrollment and dosing
in Aegeras clinical trial marks an exciting time for lymphoma patients and
LLSC. We are pleased to help accelerate the testing of a new therapeutic
option for blood cancer patients and that Canadian lymphoma patients are
among the first to participate in this trial.
About AEG35156
Cancer cells acquire multiple mutations that disable their normal
response to apoptotic triggers. AEG35156, a second generation antisense
which targets XIAP, is designed to lower the apoptotic threshold of cancer
cells, enhancing their sensitivity to intrinsic death and chemotherapy,
without harming healthy cells. Aegeras published data with AEG35156, both
in vitro and in vivo, strongly supports this hypothesis, and validates XIAP
as a novel drug target for the development of anti-cancer therapeutics.
About Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical stage biotechnology company focused
on developing drugs that control apoptosis to address major unmet medical
needs. In addition to AEG35156, Aegera has three additional programs in
clinical development for the treatment of cancer and neuropathic pain.
Details of these programs can be found on Aegeras website at
http://www.aegera.com.
About The Leukemia Lymphoma Society
The Leukemia Lymphoma Society(R), headquartered in White Plains, NY,
with 68 chapters in the United States and Canada, is the worlds largest
voluntary health organization dedicated to funding blood cancer research
and providing education and patient services. The LLS mission: Cure
leukemia, lymphoma, Hodgkins disease and myeloma, and improve the quality
of life of patients and their families. Since its founding in 1949, LLS has
invested more than $600 million in research specifically targeting
leukemia, lymphoma and myeloma. Last year alone, LLS made 5.1 million
contacts with patients, caregivers and healthcare professionals.
For more information about blood cancer, visit http://www.LLS.org or call the
LLS Information Resource Center (IRC), a call center staffed by masters
level social workers, nurses and health educators who provide information,
support and resources to patients and their families and caregivers. IRC
information specialists are available at (800) 955-4572, Monday through
Friday, 9 a.m. to 6 p.m. ET.
For further information:
  Aegera Therapeutics Inc.
  Donald Olds, MSc, MBA
  Chief Operating Officer CFO
  (514) 288-5532 *295
  Email: donald.olds@aegera.com
SOURCE Aegera Therapeutics Inc.

More info about clinical oncology

Aegera Therapeutics Inc. is pleased to announce the dosing of the first patient in a fifth phase 1 and 2 clinical oncology study of AEG35156, a second generation antisense therapeutic targeting XIAP, a key member of the Inhibitor of Apoptosis protein family.
The study, made possible, in part, by funding from The Leukemia Lymphoma Society, is entitled A Phase 1-2, Multicenter, Open-Label Study of the X- Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma and Follicular Lymphoma. It is being conducted at the Princess Margaret Hospital (PMH) located in Toronto, Ontario, and is led by Principal Investigator Dr. Christine Chen, with co-Principal Investigators Dr. Aaron Schimmer and Dr. Joe Brandwein, all from the PMHs Department of Hematology and Oncology.
The primary objective of this study is to determine the recommended dose of AEG35156 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and follicular lymphoma (FL), and to determine the safety profile and response rate to AEG35156 in these patient populations.
Preliminary evidence of activity in lymphoma was observed in phase 1 studies with AEG35156, stated Dr. Jacques Jolivet, Aegeras VP Clinical. This clinical trial will specifically study the role played by XIAP knockdown in inducing antitumor activity in CLL, SLL and FL.
Our clinical program around AEG35156 continues to expand and broaden as we seek to move this therapeutic forward to approval, added Aegeras President and Chief Executive Officer, Dr. Michael J. Berendt. By adding these lymphoma indications to AEG35156s ongoing phase 1 and 2 studies in leukemia (AML), pancreatic, breast, and non-small cell lung cancer, we continue to seek to position AEG35156 as an important therapeutic option that could address important unmet medical needs across a spectrum of cancer indications. I must also thank, once again, The Leukemia Lymphoma Society for their financial support of this study which is the first funding granted for a clinical trial under their new Therapy Acceleration Program.
The Leukemia Lymphoma Society Canada (LLSC) National Board Chairman, Robert Rollwagen, added, The initiation of patient enrollment and dosing in Aegeras clinical trial marks an exciting time for lymphoma patients and LLSC. We are pleased to help accelerate the testing of a new therapeutic option for blood cancer patients and that Canadian lymphoma patients are among the first to participate in this trial.
About AEG35156
Cancer cells acquire multiple mutations that disable their normal response to apoptotic triggers. AEG35156, a second generation antisense which targets XIAP, is designed to lower the apoptotic threshold of cancer cells, enhancing their sensitivity to intrinsic death and chemotherapy, without harming healthy cells. Aegeras published data with AEG35156, both in vitro and in vivo, strongly supports this hypothesis, and validates XIAP as a novel drug target for the development of anti-cancer therapeutics.
About Aegera Therapeutics Inc.
Aegera Therapeutics is a clinical stage biotechnology company focused on developing drugs that control apoptosis to address major unmet medical needs. In addition to AEG35156, Aegera has three additional programs in clinical development for the treatment of cancer and neuropathic pain. Details of these programs can be found on Aegeras website at http://www.aegera.com.
About The Leukemia Lymphoma Society
The Leukemia Lymphoma Society(R), headquartered in White Plains, NY, with 68 chapters in the United States and Canada, is the worlds largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The LLS mission: Cure leukemia, lymphoma, Hodgkins disease and myeloma, and improve the quality of life of patients and their families. Since its founding in 1949, LLS has invested more than $600 million in research specifically targeting leukemia, lymphoma and myeloma. Last year alone, LLS made 5.1 million contacts with patients, caregivers and healthcare professionals.
Aegera Therapeutics Inc.
http://www.aegera.

See more: clinical oncology

An international, prospective clinical trial found the number of circulating tumor cells (CTCs) is a strong indicator of progression-free and overall survival among metastatic colorectal cancer patients, according to a report published in the July 1 issue of the Journal of Clinical Oncology.
The study, conducted in the US, the Netherlands, and the United Kingdom, found that metastatic colorectal cancer patients with fewer than three circulating tumor cells in their bloodstream had significantly better overall survival than patients with more than three CTCs.
Given the variety of cancer drugs available today, the ability to monitor CTCs in conjunction with radiological assessment may help physicians and patients make more informed and timely treatment decisions, said lead investigator and author Steven J. Cohen, M.D.*, Attending Physician at Fox Chase Cancer Center. Obtaining measurements of CTCs for patients with metastatic colorectal cancer beginning a new therapy can provide additional information about their prognosis, and may also be followed serially to assist with clinical management.
These findings were included in a report titled, Relationship of Circulating Tumor Cells to Tumor Response, Progression-Free Survival, and Overall Survival in Patients with Metastatic Colorectal Cancer, which summarizes data from a prospective trial involving 430 colorectal cancer patients at 55 clinical centers using the CellSearcha System to count CTCs. Researchers counted the number of circulating tumor cells in the peripheral blood of patients at baseline and after starting first-, second-, or third-line therapy.
The CellSearch System is the first diagnostic test to automate the process of identifying and counting circulating tumor cells (CTCs) in a blood sample. This system helps physicians to predict disease progression and patient survival any time during therapy through its ability to locate minute numbers of circulating tumor cells in the approximately 40 billion cells contained in a 7.5 ml sample of blood an achievement never before documented in any diagnostic tool.
Clinical studies continue to validate the significance of circulating tumor cells in treating patients with metastatic breast, colorectal or prostate cancer, said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. This study demonstrates the clinical value of circulating tumor cells in predicting progression-free and overall survival rates.
According to the American Cancer Society, colorectal cancer claims approximately 55,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic colorectal cancer occurs when tumor cells spread to other locations in the body and grow. Although there are several options for the treatment of metastatic colorectal cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient.
The U.S. Food and Drug Administration (FDA) first cleared The CellSearch System in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer. The FDA has since granted expanded clearance for the CellSearch System as an aid in monitoring metastatic colorectal and metastatic prostate cancer patients.
About Veridex
Veridex, LLC, a Johnson Johnson company, is an organization dedicated to providing physicians with high-value in vitro diagnostic oncology products. Veridexs products may significantly benefit patients through earlier disease detection and may enable personalized strategies to help improve patient management and outcomes. For more information, please visit http://www.veridex.com.

See more: clinical oncology

Cephalon, Inc. (Nasdaq: CEPH) announced that in a phase 2 study published online in the Journal of Clinical Oncology, 92 percent of patients with relapsed indolent B-cell and mantle cell non-Hodgkins lymphoma (NHL) responded to treatment with TREANDA(R) (bendamustine hydrochloride) for Injection plus rituximab. This combination study is one of three studies in patients with NHL that Cephalon submitted in December 2007 to the U.S. Food and Drug Administration requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. TREANDA was approved by the FDA in March 2008 for the treatment of patients with chronic lymphocytic leukemia and is not currently approved for use in NHL.
A variety of treatment options have been employed in patients with indolent B-cell and mantle cell lymphomas, but resistance to treatment in this patient population often limits effective therapeutic options, said Dr. Charles Morris, Vice President, Worldwide Clinical Research at Cephalon. Based on what we saw in this study, the combination of TREANDA with rituximab appears to elicit a high rate of durable responses and encouraging progression-free survival.
About the Study
In this multi-center, open-label, single arm, Phase 2 study, 66 patients with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab therapy were treated. Patients received rituximab 375 mg/meter squared intravenously on day one and TREANDA 90 mg/meter squared intravenously on days two and three of a 28-day cycle for up to six cycles. An additional dose of rituximab was given one week before the first cycle and four weeks after the last cycle.
Overall response rate was 92 percent with a complete response rate (CR) of 41 percent. A CR means that after treatment with the TREANDA and rituximab combination, patients had no detectable evidence of disease. These responses were durable, with a median duration of 21 months overall (19 months for the mantle cell population). Additionally, the combination of TREANDA and rituximab was associated with progression-free survival (PFS) of 23 months overall and for patients with mantle cell lymphoma.
In this published study, the combination of both treatments was generally well tolerated. The most common adverse events in the trial included myelosuppression (a condition in which bone marrow activity is decreased), nausea, infection, fatigue, constipation, and diarrhea.
This combination study is one of three studies in patients with NHL that Cephalon submitted to the FDA in December 2007 requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. The other two studies evaluated the efficacy and safety of TREANDA as monotherapy in this patient population. In all three studies, patients treated with TREANDA had a high rate of response and a manageable side effect profile, with myelosuppression as the most common side effect. Cephalon anticipates a review decision on this application by the agency by October 31, 2008.
About Non-Hodgkins Lymphoma
According to the American Cancer Society, an estimated 66,000 people in the United States will be diagnosed in 2008 with NHL. There are approximately 30 different types of NHL, which have been divided into two major categories: indolent (or slow growing) and aggressive. Indolent B-cell lymphoma and mantle cell lymphoma (one of the more aggressive sub-types) are difficult to treat because patients are prone to relapse after treatment.
About TREANDA
TREANDA has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that TREANDA can lead to cell death via several pathways. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) and potentially by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of TREANDA remains unknown.
Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries.
About Cephalon Oncology
Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds. In addition to TREANDA, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX(R) (arsenic trioxide) injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets two additional oncology products: Myocet(R) (liposomal doxorubicin), indicated in combination with cyclophospamide for the first-line treatment of metastatic breast cancer and Targretin(R) (bexarotene) a treatment for advanced cutaneous T-cell lymphoma.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the companys headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The companys European headquarters are located in Maisons-Alfort, France.
The companys proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalons current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including the results of any clinical programs with respect to TREANDA or the timing or approval of any current or future filings for regulatory approval of TREANDA or other Cephalon Oncology compounds; interpretation of clinical results, particularly with respect to the TREANDA clinical trials; manufacturing development and capabilities; market prospects for its products; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as or other words and terms of similar meaning. Cephalons performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
http://www.cephalon.com
View drug information on Actiq; Naltrexone Hydrochloride Tablets; Nuvigil.

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See more: clinical oncology

a
Cephalon, Inc. (Nasdaq:
CEPH) announced that in a phase 2 study published online in the
Journal of Clinical Oncology, 92 percent of patients with relapsed indolent
B-cell and mantle cell non-Hodgkins lymphoma (NHL) responded to treatment
with TREANDA(R) (bendamustine hydrochloride) for Injection plus rituximab.
This combination study is one of three studies in patients with NHL that
Cephalon submitted in December 2007 to the U.S. Food and Drug
Administration requesting approval of TREANDA for the treatment of patients
with indolent NHL who have progressed during or following treatment with
rituximab or a rituximab-containing regimen. TREANDA was approved by the
FDA in March 2008 for the treatment of patients with chronic lymphocytic
leukemia and is not currently approved for use in NHL.
A variety of treatment options have been employed in patients with
indolent B-cell and mantle cell lymphomas, but resistance to treatment in
this patient population often limits effective therapeutic options, said
Dr. Charles Morris, Vice President, Worldwide Clinical Research at
Cephalon. Based on what we saw in this study, the combination of TREANDA
with rituximab appears to elicit a high rate of durable responses and
encouraging progression-free survival.
About the Study
In this multi-center, open-label, single arm, Phase 2 study, 66
patients with relapsed, indolent B-cell or mantle cell lymphoma without
documented resistance to prior rituximab therapy were treated. Patients
received rituximab 375 mg/meter squared intravenously on day one and
TREANDA 90 mg/meter squared intravenously on days two and three of a 28-day
cycle for up to six cycles. An additional dose of rituximab was given one
week before the first cycle and four weeks after the last cycle.
Overall response rate was 92 percent with a complete response rate (CR)
of 41 percent. A CR means that after treatment with the TREANDA and
rituximab combination, patients had no detectable evidence of disease.
These responses were durable, with a median duration of 21 months overall
(19 months for the mantle cell population). Additionally, the combination
of TREANDA and rituximab was associated with progression-free survival
(PFS) of 23 months overall and for patients with mantle cell lymphoma.
In this published study, the combination of both treatments was
generally well tolerated. The most common adverse events in the trial
included myelosuppression (a condition in which bone marrow activity is
decreased), nausea, infection, fatigue, constipation, and diarrhea.
This combination study is one of three studies in patients with NHL
that Cephalon submitted to the FDA in December 2007 requesting approval of
TREANDA for the treatment of patients with indolent NHL who have progressed
during or following treatment with rituximab or a rituximab-containing
regimen. The other two studies evaluated the efficacy and safety of TREANDA
as monotherapy in this patient population. In all three studies, patients
treated with TREANDA had a high rate of response and a manageable side
effect profile, with myelosuppression as the most common side effect.
Cephalon anticipates a review decision on this application by the agency by
October 31, 2008.
About Non-Hodgkins Lymphoma
According to the American Cancer Society, an estimated 66,000 people in
the United States will be diagnosed in 2008 with NHL. There are
approximately 30 different types of NHL, which have been divided into two
major categories: indolent (or slow growing) and aggressive. Indolent
B-cell lymphoma and mantle cell lymphoma (one of the more aggressive
sub-types) are difficult to treat because patients are prone to relapse
after treatment.
About TREANDA
TREANDA has a unique chemical structure with two primary components, an
alkylating group and a benzimidazole component. Preclinical data suggest
that TREANDA can lead to cell death via several pathways. TREANDA damages
the DNA in cancer cells, which leads to cell death by a process known as
apoptosis (programmed cell death) and potentially by an alternate cell
death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of
normal cell division). The exact mechanism of action of TREANDA remains
unknown.
Cephalon holds exclusive rights to market and develop TREANDA in the
United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine
HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas
licensee, Mundipharma International Corporation Limited, under the
tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a
single-agent or in combination with other anti-cancer agents for indolent
NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive
rights to develop and market bendamustine HCl in Japan and selected Asia
Pacific Rim countries.
About Cephalon Oncology
Cephalon Oncology is a strategic business unit focused on the
development and commercialization of oncology products and resources for
patients and healthcare providers. The Cephalon Oncology portfolio includes
a number of promising investigational and marketed compounds. In addition
to TREANDA, the Cephalon Oncology therapeutic portfolio in the United
States includes TRISENOX(R) (arsenic trioxide) injection, a product
approved in the United States for the treatment of patients with relapsed
or refractory acute promyelocytic leukemia, and CEP-701, an oral small
molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in
phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets two additional oncology products: Myocet(R)
(liposomal doxorubicin), indicated in combination with cyclophospamide for
the first-line treatment of metastatic breast cancer and Targretin(R)
(bexarotene) a treatment for advanced cutaneous T-cell lymphoma.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and commercialization of
innovative products in four core therapeutic areas: central nervous system,
pain, oncology and addiction. A member of the Fortune 1000, Cephalon
currently employs approximately 3,000 people in the United States and
Europe. U.S. sites include the companys headquarters in Frazer,
Pennsylvania, and offices, laboratories or manufacturing facilities in West
Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis,
Minnesota. The companys European headquarters are located in
Maisons-Alfort, France.
The companys proprietary products in the United States include:
PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet)
[C-II], TRISENOX(R) (arsenic trioxide) injection, TREANDA, AMRIX(R)
(cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R)
(naltrexone for extended-release injectable suspension), GABITRIL(R)
(tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and
ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also
markets numerous products internationally.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalons current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products, including the results of any clinical programs with respect to
TREANDA or the timing or approval of any current or future filings for
regulatory approval of TREANDA or other Cephalon Oncology compounds;
interpretation of clinical results, particularly with respect to the
TREANDA clinical trials; manufacturing development and capabilities; market
prospects for its products; sales and earnings guidance; and other
statements regarding matters that are not historical facts. You may
identify some of these forward-looking statements by the use of words in
the statements such as or other words and terms of similar meaning.
Cephalons performance and financial results could differ materially from
those reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries as well as more specific risks
and uncertainties facing Cephalon such as those set forth in its reports on
Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Therefore, you should
not rely on any such factors or forward-looking statements. Furthermore,
Cephalon does not intend to update publicly any forward-looking statement,
except as required by law. The Private Securities Litigation Reform Act of
1995 permits this discussion.
Cephalon, Inc.
http://www.cephalon.

More info about clinical oncology

Study Reports 92 Percent Response Rate to Combination Treatment FRAZER, Pa., July 15, 2008 /PRNewswire-FirstCall/ Cephalon, Inc. announced today that in a phase 2 study published online today in the Journal of Clinical Oncology, 92 percent of patients with relapsed indolent B-cell and mantle cell non-Hodgkins lymphoma (NHL) responded to treatment with Treanda(R) (bendamustine hydrochloride) for Injection plus rituximab. This combination study is one of three studies in patients with NHL that Cephalon submitted in December 2007 to the U.S. Food and Drug Administration requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. TREANDA was approved by the FDA in March 2008 for the treatment of patients with chronic lymphocytic leukemia and is not currently approved for use in NHL.
A variety of treatment options have been employed in patients with indolent B-cell and mantle cell lymphomas, but resistance to treatment in this patient population often limits effective therapeutic options, said Dr. Charles Morris, Vice President, Worldwide Clinical Research at Cephalon. Based on what we saw in this study, the combination of TREANDA with rituximab appears to elicit a high rate of durable responses and encouraging progression-free survival.

More info about clinical oncology

See more: clinical oncology

Medical negligence is where doctors or any other professional in the medical profession have been found in breach of a duty of care. For example if a doctor failed to diagnose a medical condition or diagnosed the wrong condition this would be classed as medical negligence.
Doctors, dentists, midwives, nurses, physiotherapists, psychologists and psychiatrists all have "duty of car" to ensure their patients receive the correct treatment in a proper ethical manner. If you or someone feels that they incurred an injury or suffered emotionally because one of these medical professionals not doing their job probably then you maybe able to make a medical negligence claim against them or the organisation they work for. Maybe the treatment you received went wrong in which case the treating doctor is required by his governing body the "General medical Council" to inform the patient that the treatment went wrong. At the very least you are entitled to an explanation.
Injuries such as these can arise out of for example, cancer treatment, accident and emergency treatments, anaesthetics, cardiothoracic surgery, cardiology, gastroenterology, oncology, keyhole surgery, mental health, neurosurgery, obstetrics and gynaecology, oncology, ophthalmology, orthopaedics, paediatrics, plastic surgery, psychiatry, sterilisation, urology, dentistry, vascular surgery and the list goes on. Also if you or a family member suffered brain damage or psychological injuries like nervous shock or the worst scenario death these are fine examples of medical/clinical negligence.
It is not just patients of the NHS, those who were treated in private hospitals as private patients will also be able to claim for breach of contract if your medical treatment was substandard.
Claiming financial compensation for clinical or medical negligence can be quite a lengthy and complex matter. Because of which it is paramount that you enlist the help of a professional personal injury specialist. If this puts you claiming it shouldn't. When someone claims for personal injuries (compensation) for a road traffic accident it is generally easy for your personal in jury lawyer to establish who was at fault and whether the injuries were due to that accident. If the accident wasn't your fault, and your injuries were obviously related to the accident (like whiplash), you will have a strong case. With claims against the medical profession the claimant will need to obtain medical records and get statements to prove that:
That there were serious errors in your medical treatment which no competent doctor would have made
The doctor or other healthcare professional owed a duty to take care of the claimant and not cause injury
There was a breach of that duty to take care
That breach of duty has caused harm to the claimant
Damage or other losses have resulted from that harm
Claiming compensation for clinical/medical negligence is your civil and legal right. Without claiming you could be putting someone else at risk. Sadly it take unfortunate situations like a medical error of judgement to occur for people in the medical profession to wake up and make changes to their practice to ensure this type of malpractice doesn't happen again.

See more: clinical oncology

See more: clinical oncology

) Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkin's Lymphoma
7/15/2008

FRAZER, Pa., July 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today that in a phase 2 study published online today in the Journal of Clinical Oncology, 92 percent of patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma (NHL) responded to treatment with TREANDA(R) (bendamustine hydrochloride) for Injection plus rituximab. This combination study is one of three studies in patients with NHL that Cephalon submitted in December 2007 to the U.S. Food and Drug Administration requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. TREANDA was approved by the FDA in March 2008 for the treatment of patients with chronic lymphocytic leukemia and is not currently approved for use in NHL.
"A variety of treatment options have been employed in patients with indolent B-cell and mantle cell lymphomas, but resistance to treatment in this patient population often limits effective therapeutic options," said Dr. Charles Morris, Vice President, Worldwide Clinical Research at Cephalon. "Based on what we saw in this study, the combination of TREANDA with rituximab appears to elicit a high rate of durable responses and encouraging progression-free survival."
About the Study
In this multi-center, open-label, single arm, Phase 2 study, 66 patients with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab therapy were treated. Patients received rituximab 375 mg/meter squared intravenously on day one and TREANDA 90 mg/meter squared intravenously on days two and three of a 28-day cycle for up to six cycles. An additional dose of rituximab was given one week before the first cycle and four weeks after the last cycle.
Overall response rate was 92 percent with a complete response rate (CR) of 41 percent. A CR means that after treatment with the TREANDA and rituximab combination, patients had no detectable evidence of disease. These responses were durable, with a median duration of 21 months overall (19 months for the mantle cell population). Additionally, the combination of TREANDA and rituximab was associated with progression-free survival (PFS) of 23 months overall and for patients with mantle cell lymphoma.
In this published study, the combination of both treatments was generally well tolerated. The most common adverse events in the trial included myelosuppression (a condition in which bone marrow activity is decreased), nausea, infection, fatigue, constipation, and diarrhea.
This combination study is one of three studies in patients with NHL that Cephalon submitted to the FDA in December 2007 requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. The other two studies evaluated the efficacy and safety of TREANDA as monotherapy in this patient population. In all three studies, patients treated with TREANDA had a high rate of response and a manageable side effect profile, with myelosuppression as the most common side effect. Cephalon anticipates a review decision on this application by the agency by October 31, 2008.
About Non-Hodgkin's Lymphoma
According to the American Cancer Society, an estimated 66,000 people in the United States will be diagnosed in 2008 with NHL. There are approximately 30 different types of NHL, which have been divided into two major categories: indolent (or slow growing) and aggressive. Indolent B-cell lymphoma and mantle cell lymphoma (one of the more aggressive sub-types) are difficult to treat because patients are prone to relapse after treatment.
About TREANDA
TREANDA has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that TREANDA can lead to cell death via several pathways. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) and potentially by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of TREANDA remains unknown.
Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries.
About Cephalon Oncology
Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds. In addition to TREANDA, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX(R) (arsenic trioxide) injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets two additional oncology products: Myocet(R) (liposomal doxorubicin), indicated in combination with cyclophospamide for the first-line treatment of metastatic breast cancer and Targretin(R) (bexarotene) a treatment for advanced cutaneous T-cell lymphoma.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including the results of any clinical programs with respect to TREANDA or the timing or approval of any current or future filings for regulatory approval of TREANDA or other Cephalon Oncology compounds; interpretation of clinical results, particularly with respect to the TREANDA clinical trials; manufacturing development and capabilities; market prospects for its products; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
CONTACT: Media: Jenifer Antonacci, +1-610-738-6674, jantonac@cephalon.com,
or Investors: Robert (Chip) Merritt, +1-610-738-6376,
cmerritt@cephalon.com, both of Cephalon, Inc.
Web site: http://www.cephalon.com/
Company News On-Call: http://www.prnewswire.com/comp/134563.

More info about clinical oncology

) Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkin's Lymphoma
7/15/2008

FRAZER, Pa., July 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today that in a phase 2 study published online today in the Journal of Clinical Oncology, 92 percent of patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma (NHL) responded to treatment with TREANDA(R) (bendamustine hydrochloride) for Injection plus rituximab. This combination study is one of three studies in patients with NHL that Cephalon submitted in December 2007 to the U.S. Food and Drug Administration requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. TREANDA was approved by the FDA in March 2008 for the treatment of patients with chronic lymphocytic leukemia and is not currently approved for use in NHL.
"A variety of treatment options have been employed in patients with indolent B-cell and mantle cell lymphomas, but resistance to treatment in this patient population often limits effective therapeutic options," said Dr. Charles Morris, Vice President, Worldwide Clinical Research at Cephalon. "Based on what we saw in this study, the combination of TREANDA with rituximab appears to elicit a high rate of durable responses and encouraging progression-free survival."
About the Study
In this multi-center, open-label, single arm, Phase 2 study, 66 patients with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab therapy were treated. Patients received rituximab 375 mg/meter squared intravenously on day one and TREANDA 90 mg/meter squared intravenously on days two and three of a 28-day cycle for up to six cycles. An additional dose of rituximab was given one week before the first cycle and four weeks after the last cycle.
Overall response rate was 92 percent with a complete response rate (CR) of 41 percent. A CR means that after treatment with the TREANDA and rituximab combination, patients had no detectable evidence of disease. These responses were durable, with a median duration of 21 months overall (19 months for the mantle cell population). Additionally, the combination of TREANDA and rituximab was associated with progression-free survival (PFS) of 23 months overall and for patients with mantle cell lymphoma.
In this published study, the combination of both treatments was generally well tolerated. The most common adverse events in the trial included myelosuppression (a condition in which bone marrow activity is decreased), nausea, infection, fatigue, constipation, and diarrhea.
This combination study is one of three studies in patients with NHL that Cephalon submitted to the FDA in December 2007 requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. The other two studies evaluated the efficacy and safety of TREANDA as monotherapy in this patient population. In all three studies, patients treated with TREANDA had a high rate of response and a manageable side effect profile, with myelosuppression as the most common side effect. Cephalon anticipates a review decision on this application by the agency by October 31, 2008.
About Non-Hodgkin's Lymphoma
According to the American Cancer Society, an estimated 66,000 people in the United States will be diagnosed in 2008 with NHL. There are approximately 30 different types of NHL, which have been divided into two major categories: indolent (or slow growing) and aggressive. Indolent B-cell lymphoma and mantle cell lymphoma (one of the more aggressive sub-types) are difficult to treat because patients are prone to relapse after treatment.
About TREANDA
TREANDA has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that TREANDA can lead to cell death via several pathways. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) and potentially by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of TREANDA remains unknown.
Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asia Pacific Rim countries.
About Cephalon Oncology
Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds. In addition to TREANDA, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX(R) (arsenic trioxide) injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets two additional oncology products: Myocet(R) (liposomal doxorubicin), indicated in combination with cyclophospamide for the first-line treatment of metastatic breast cancer and Targretin(R) (bexarotene) a treatment for advanced cutaneous T-cell lymphoma.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. The company's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including the results of any clinical programs with respect to TREANDA or the timing or approval of any current or future filings for regulatory approval of TREANDA or other Cephalon Oncology compounds; interpretation of clinical results, particularly with respect to the TREANDA clinical trials; manufacturing development and capabilities; market prospects for its products; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
CONTACT: Media: Jenifer Antonacci, +1-610-738-6674, jantonac@cephalon.com,
or Investors: Robert (Chip) Merritt, +1-610-738-6376,
cmerritt@cephalon.com, both of Cephalon, Inc.
Web site: http://www.cephalon.com/
Company News On-Call: http://www.prnewswire.com/comp/134563.

More info about clinical oncology

More info about clinical oncology