Capecitabine News and Research

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Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Genentech, a member of the Roche Group, today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.

7 Jul 2010

EMA grants Scientific Advice to Aeterna Zentaris for Phase 3 trial of anticancer compound perifosine

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer.

30 Jun 2010

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Keryx Biopharmaceuticals, Inc. today announced that abstract O-0017, entitled "Subset Analysis of 5-FU Refractory Patients from a Randomized Ph II Study of Perifosine + Capecitabine (P-CAP) vs. Placebo + Capecitabine (CAP) in Patients with 2nd or 3rd Line Metastatic CRC" has been selected for oral presentation at the upcoming 12th World Congress on Gastrointestinal Cancer, to be held in Barcelona, Spain from June 30 - July 2, 2010.

30 Jun 2010

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

29 Jun 2010

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

Groundbreaking studies will be presented at the ESMO 12th World Congress on Gastrointestinal Cancer next week in Barcelona, Spain, including exciting new data on treatment for neuroendocrine tumors. "The presentations this year are very significant for clinicians, and outline real progress in the development of agents that are effective in managing and treating gastrointestinal diseases," says Eric Van Cutsem, MD, PhD of the University Hospital Gasthuisberg in Leuven, Belgium and Congress co-chair.

23 Jun 2010

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

ZIOPHARM Oncology, Inc. announced guidance today regarding the Company's planned pivotal Phase III trial for palifosfamide in metastatic soft tissue sarcoma, including details of the proposed study's design, timing and regulatory review.

21 Jun 2010

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colorectal cancer.

10 Jun 2010

NICE decides not to recommend lapatinib for women with advanced breast cancer

The National Institute for Health and Clinical Excellence has decided not to recommend the oral drug lapatinib (Tyverb) for women with advanced breast cancer, except for use in clinical trials.

10 Jun 2010

Positive initial results from Nektar Therapeutics' NKTR-102 Phase 2 study for metastatic breast cancer

Nektar Therapeutics today announced positive preliminary initial results from a two-stage Phase 2 clinical study evaluating single-agent NKTR-102 in women with advanced/metastatic breast cancer patients who have received a prior taxane. The increased use of taxanes in breast cancer often renders tumors resistant to these drugs by the time the disease recurs, thereby underscoring the urgent need for new treatment options with novel mechanisms of action for metastatic disease.

10 Jun 2010

Multiple presentations on nab-driven chemotherapy at 46th ASCO

Abraxis BioScience, Inc. presented abstracts describing 10 trials of nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension), for the treatment of breast cancer at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

9 Jun 2010

ZIOPHARM presents positive data from PICASSO Phase II trial for soft tissue sarcoma at 46th ASCO

ZIOPHARM Oncology, Inc. announced today that Dr. Claire Verschraegen of the University of New Mexico, Albuquerque and first author of the abstract, "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)," (Abstract #10004) presented in an oral session today updated positive data from PICASSO.

8 Jun 2010

Phase Ib/II trial data for trastuzumab-DM1 in combination with pertuzumab presented at ASCO 2010

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of clinical data from a Phase Ib/II trial conducted by Roche and Genentech to investigate the safety and preliminary efficacy of trastuzumab-DM1 (T-DM1) used in combination with Roche's investigational antibody, pertuzumab.

7 Jun 2010

ACT Biotech's Telatinib receives orphan drug designation from FDA for treatment of gastric cancer

ACT Biotech Inc., a privately held biotechnology company developing a portfolio of oral kinase inhibitors as anti-cancer drugs, announced today that the company's highly selective oral kinase inhibitor, Telatinib, has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of gastric cancer.

3 Jun 2010

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

Pfizer Oncology will present new data highlighting the company's focused approach to cancer drug development through the identification and validation of molecular targets. These results will be presented at the 46th Annual American Society of Clinical Oncology meeting in Chicago from June 4-8.

21 May 2010

ZIOPHARM Oncology to present phase II data from PICASSO trial for soft tissue sarcoma at ASCO meeting

ZIOPHARM Oncology, Inc. announced today that Dr. Claire Verschraegen of the University of New Mexico, Albuquerque, lead author of the abstract on the palifosfamide study entitled, "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)", will present in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting on Monday, June 7th at 2:15 pm in the Vista Room (location S 406).

21 May 2010

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrinology, today reported financial and operating results as at and for the three months ended March 31, 2010.

13 May 2010

Array BioPharma reports 18.4M revenue for third-quarter fiscal 2010

Array BioPharma Inc. today reported financial results for the third quarter of fiscal 2010.

4 May 2010

ZIOPHARM reports a net loss of $17.7 million in first quarter 2010

ZIOPHARM Oncology, Inc., a biopharmaceutical company that is seeking to develop and commercialize a diverse, risk sensitive portfolio of in-licensed cancer drugs addressing unmet medical needs, today reported its financial results for the three months ended March 31, 2010 and updated the Company's continued progress with its clinical programs.

3 May 2010

Immunogen reports a net loss of $12.1 million in third quarter 2010

ImmunoGen, Inc., a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today announced financial results for the three-month period ended March 31, 2010 - the third quarter of the Company's 2010 fiscal year (3QFY10).

30 Apr 2010

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

Genentech, Inc., a wholly owned member of the Roche Group, announced today that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Herceptin® (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer.

23 Apr 2010

Capecitabine News and Research

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

EMA grants Scientific Advice to Aeterna Zentaris for Phase 3 trial of anticancer compound perifosine

Ph II data of perifosine + capecitabine in metastatic CRC to be presented at gastrointestinal cancer congress

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

New presentations on neuroendocrine tumors at ESMO 12th World Congress on Gastrointestinal Cancer

ZIOPHARM Oncology announces guidance on palifosfamide Phase III trial in metastatic soft tissue sarcoma

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

NICE decides not to recommend lapatinib for women with advanced breast cancer

Positive initial results from Nektar Therapeutics' NKTR-102 Phase 2 study for metastatic breast cancer

Multiple presentations on nab-driven chemotherapy at 46th ASCO

ZIOPHARM presents positive data from PICASSO Phase II trial for soft tissue sarcoma at 46th ASCO

Phase Ib/II trial data for trastuzumab-DM1 in combination with pertuzumab presented at ASCO 2010

ACT Biotech's Telatinib receives orphan drug designation from FDA for treatment of gastric cancer

New data highlighting Pfizer's approach to cancer drug development to be presented at ASCO meeting

ZIOPHARM Oncology to present phase II data from PICASSO trial for soft tissue sarcoma at ASCO meeting

Aeterna Zentaris posts net loss of $5.9 million for first-quarter 2010

Array BioPharma reports 18.4M revenue for third-quarter fiscal 2010

ZIOPHARM reports a net loss of $17.7 million in first quarter 2010

Immunogen reports a net loss of $12.1 million in third quarter 2010

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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