Capecitabine News and Research

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Æterna Zentaris Zentaris requests EMA Scientific Advice for Phase 3 program with perifosine

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has requested Scientific Advice from the European Medicines Agency (EMA) to assure the acceptability of the recently initiated Phase 3 programs for the development of its lead anticancer compound, perifosine, in its two lead indications, multiple myeloma and refractory advanced colorectal cancer.

15 Apr 2010

Keryx Biopharmaceuticals commences Phase 3 registration clinical trial for perifosine

Keryx Biopharmaceuticals, Inc. announced today the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer.

9 Apr 2010

Æterna Zentaris commences perifosine Phase 3 registration trial

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced the initiation of a Phase 3 registration clinical trial with perifosine (KRX-0401) ), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.

9 Apr 2010

ZIOPHARM Oncology commences Phase I/II study of Zybulin for metastatic breast cancer

ZIOPHARM Oncology, Inc., announced today it has initiated a Phase I/II study at Memorial Sloan-Kettering Cancer Center for the novel, mathematically - determined administration of oral indibulin (Zybulin™ or ZIO-301) in the treatment of metastatic breast cancer.

9 Apr 2010

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Genta Incorporated today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

7 Apr 2010

Investment report on Keryx Biopharmaceuticals from BeaconEquity.com

BeaconEquity.com announces an investment report featuring Keryx Biopharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

6 Apr 2010

Keryx Biopharmaceuticals' perifosine receives FDA Fast Track Designation

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.

5 Apr 2010

FDA grants Keryx Biopharmaceuticals Fast Track designation for perifosine

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, was granted Fast Track designation by the U.S. Food and Drug Administration for perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of refractory advanced colorectal cancer.

5 Apr 2010

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

Genta Incorporated today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company's newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development.

31 Mar 2010

ZIOPHARM Oncology reports fourth quarter net income of $1.0M against loss last year

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, announced today its financial results for the fourth quarter and full year 2009, and the filing of its Annual Report on Form 10-K with the Securities and Exchange Commission.

18 Mar 2010

Two Phase 3 studies of Sutent in advanced breast cancer fail to meet primary endpoints

Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone.

12 Mar 2010

Herceptin as add-on to standard chemotherapy for gastric cancer earns Decision Resources' gold standard status

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, for the treatment of gastric cancer, Roche/Genentech/ Chugai's Herceptin as an add-on to standard chemotherapy earns Decision Resources' proprietary clinical gold standard status in 2013, following its approval for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive gastric cancer in 2010.

9 Mar 2010

Genentech's Avastin combination Phase III study in advanced stomach cancer does not meet primary endpoint

Genentech, Inc., a wholly owned member of the Roche Group, today announced that a Phase III study (AVAGAST) did not meet its primary endpoint of showing Avastin® (bevacizumab) plus Xeloda® (capecitabine) or 5-FU and cisplatin chemotherapy extended the lives of people with inoperable or advanced stomach (gastric) cancer, compared to chemotherapy alone.

23 Feb 2010

CINJ researchers test malaria drug for colorectal cancer treatment

While new cases of colorectal cancer continue to decline in the United States, it remains the third leading cause of cancer death in the nation, according to the American Cancer Society. That is why researchers at The Cancer Institute of New Jersey are looking to add a drug known for fighting malaria to traditional chemotherapy for colorectal cancer to see if treatment can be made more effective for patients.

23 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

FDA approves new drug combination for hormone positive and HER2-positive advanced breast cancer

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

30 Jan 2010

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

29 Jan 2010

Genentech announces Phase III study of Avastin in women treated with chemotherapy for advanced breast cancer

Genentech, Inc., a wholly owned member of the Roche Group, today announced results from a Phase III study (RIBBON 2) of Avastin® (bevacizumab) in women who had previously been treated with initial (first-line) chemotherapy for advanced HER2-negative breast cancer and needed additional (second-line) treatment.

14 Dec 2009

CTRC-AACR San Antonio Breast Cancer Symposium presents new data on emerging breast cancer therapies

Breast cancer continues to be a dynamic field of research, and the CTRC-AACR San Antonio Breast Cancer Symposium, now in its 32nd year, is the premier destination to present new data on emerging therapies.

14 Dec 2009

Pfizer announces results from studies evaluating neratinib

Pfizer Inc. today announced results from studies evaluating neratinib (HKI-272), an investigational, orally administered, pan-ErbB inhibitor, in patients with human epidermal growth factor receptor-2 (HER2, also known as ErbB2) positive breast cancer at the 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

14 Dec 2009

Capecitabine News and Research

Æterna Zentaris Zentaris requests EMA Scientific Advice for Phase 3 program with perifosine

Keryx Biopharmaceuticals commences Phase 3 registration clinical trial for perifosine

Æterna Zentaris commences perifosine Phase 3 registration trial

ZIOPHARM Oncology commences Phase I/II study of Zybulin for metastatic breast cancer

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Investment report on Keryx Biopharmaceuticals from BeaconEquity.com

Keryx Biopharmaceuticals' perifosine receives FDA Fast Track Designation

FDA grants Keryx Biopharmaceuticals Fast Track designation for perifosine

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

ZIOPHARM Oncology reports fourth quarter net income of $1.0M against loss last year

Two Phase 3 studies of Sutent in advanced breast cancer fail to meet primary endpoints

Herceptin as add-on to standard chemotherapy for gastric cancer earns Decision Resources' gold standard status

Genentech's Avastin combination Phase III study in advanced stomach cancer does not meet primary endpoint

CINJ researchers test malaria drug for colorectal cancer treatment

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

FDA approves new drug combination for hormone positive and HER2-positive advanced breast cancer

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

Genentech announces Phase III study of Avastin in women treated with chemotherapy for advanced breast cancer

CTRC-AACR San Antonio Breast Cancer Symposium presents new data on emerging breast cancer therapies

Pfizer announces results from studies evaluating neratinib

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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