Small Cell Lung Cancer News and Research

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Small cell lung cancer is a disease in which malignant (cancer) cells form in the tissues of the lung. Small cell lung cancer is an aggressive (fast-growing) cancer that can spread to other parts of the body. The cancer cells look small and oval-shaped when looked at under a microscope.

Tarceva Phase III EURTAC study in NSCLC patients with EGFR activating mutations meets primary endpoint

Genentech, a member of the Roche Group and OSI Pharmaceuticals, a wholly owned subsidiary of Astellas U.S. Holding Inc., a holding company owned by Astellas Pharma Inc., today announced that an independent data monitoring committee has recommended that the Phase III EURTAC study be stopped early because the study met its primary endpoint.

28 Jan 2011

Interim results from ganetespib Phase 2 trial in NSCLC to be presented at 11th IASLC annual meeting

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that Dr. Jonathan Goldman, M.D., Premiere Oncology will present interim results from a Phase 2 trial of ganetespib in non-small cell lung cancer at the International Association for the Study of Lung Cancer 11th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting.

28 Jan 2011

Iniparib Phase III study in metastatic triple-negative breast cancer does not meet primary goal

Sanofi-aventis and its subsidiary, BiPar Sciences, today announced that a randomized Phase III trial evaluating iniparib (BSI-201) in patients with metastatic triple-negative breast cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression-free survival

28 Jan 2011

ArQule's ARQ 197 Phase 1 clinical trial results in colorectal cancer presented at ASCO 2011

ArQule, Inc. today announced the presentation of Phase 1 results of a clinical trial among patients with metastatic colorectal cancer (CRC) treated with ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, in combination with irinotecan and cetuximab. ARQ 197 is under development by Daiichi Sankyo Co., Ltd. and ArQule.

24 Jan 2011

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

NewLink Genetics Corporation today announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California.

21 Jan 2011

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

ZIOPHARM Oncology, Inc., announced today that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL).

20 Jan 2011

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

ADVENTRX Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine (ANX-530) New Drug Application (NDA).

20 Jan 2011

Geron commences enrollment in imetelstat Phase 2 clinical trial in essential thrombocythemia

Geron Corporation today announced enrollment of the first patient in a Phase 2 clinical trial to evaluate the activity of the company's telomerase inhibitor drug, imetelstat (GRN163L), in patients with essential thrombocythemia (ET).

19 Jan 2011

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today highlighted a further analysis of the large randomized Phase II OPUS study demonstrating an association between early tumor shrinkage and long-term median overall survival (OS) of more than 2 years for patients with KRAS wild-type metastatic colorectal cancer (mCRC) treated with Erbitux® (cetuximab) plus FOLFOX standard chemotherapy.

19 Jan 2011

Pfizer initiates rolling submission of crizotinib NDA for ALK-positive advanced NSCLC

Pfizer Inc. announced today that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for crizotinib (PF-02341066), an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Pfizer expects to complete the submission in the first half of 2011.

13 Jan 2011

Daiichi Sankyo and ArQule initiate enrollment in ARQ 197 Phase 3 trial in NSCLC

Daiichi Sankyo Company, Limited and ArQule, Inc. today announced that the first patient has been enrolled in the Phase 3 trial of ARQ 197, an investigational selective inhibitor of the c-Met receptor tyrosine kinase, in combination with erlotinib, for patients diagnosed with non-squamous, non-small cell lung cancer (NSCLC) who have received one or two prior systemic anti-cancer therapies.

12 Jan 2011

Epigenetic therapy holds promise for cancer management

Syndax, a clinical-stage epigenetics oncology company, announced publication of data of entinostat combined with the demethylating agent Vidaza® (azacitidine) showing effect in reducing tumor burden in differentiated tumor cells in animal tumor models of non-small cell lung cancer (NSCLC). The data is being published in the January 15, 2011 issue of Cancer Research.

12 Jan 2011

Cyclacel opens enrollment of sapacitabine Phase 3 trial for AML

Cyclacel Pharmaceuticals, Inc., today announced that it has opened enrollment of the SEAMLESS pivotal Phase 3 trial for the Company's sapacitabine oral capsules as a front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.

11 Jan 2011

Study supports use of telomerase inhibitors for treatment of childhood cancers

Geron Corporation today announced the publication of preclinical data demonstrating that the company's telomerase inhibitor drug, imetelstat (GRN163L), currently in Phase 2 clinical trials, selectively targets cancer stem cells in pediatric tumors of neural origin.

11 Jan 2011

Oncolytics opens enrollment in REOLYSIN combination U.S. Phase I colorectal cancer study

Oncolytics Biotech Inc. announced today that a U.S. Phase I study of REOLYSIN® in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil (5-FU) + Irinotecan) in patients with oxaliplatin refractory/intolerant Kras mutant colorectal cancer (REO 022) is now open to enrollment. The principal investigator is Dr. Sanjay Goel of the Montefiore Medical Center at The Albert Einstein College of Medicine in New York.

10 Jan 2011

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Exelixis, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011.

10 Jan 2011

Infinity provides guidance on anticipated pipeline and business goals for 2011

Infinity Pharmaceuticals, Inc. today provided guidance on its anticipated pipeline and business goals for 2011. Infinity begins the year with a broad pipeline of four drug candidates in clinical development and a fifth expected to enter the clinic during the year. The company also enters 2011 with approximately $345 million in committed capital.

7 Jan 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

ZIOPHARM Oncology, a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector Technology.

7 Jan 2011

Antigenics announces name change to Agenus

Antigenics Inc. today announced that effective immediately it is changing its name to Agenus Inc. The company's stock will continue to be traded on NASDAQ under the symbol AGEN. The new name reflects the broadening of the company's product portfolio of clinical candidates beyond autologous antigen-based vaccines, as well as its commitment to actively pursuing licensing opportunities to leverage its development capabilities and expand its product portfolio.

6 Jan 2011

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

Sanofi-aventis and its wholly-owned subsidiary, BiPar Sciences, today announced that The New England Journal of Medicine published the final phase II data for the investigational drug iniparib demonstrating significant clinical benefit in women with metastatic triple negative breast cancer when iniparib was administered in combination with chemotherapy agents gemcitabine/carboplatin.

6 Jan 2011

Small Cell Lung Cancer News and Research

Tarceva Phase III EURTAC study in NSCLC patients with EGFR activating mutations meets primary endpoint

Interim results from ganetespib Phase 2 trial in NSCLC to be presented at 11th IASLC annual meeting

Iniparib Phase III study in metastatic triple-negative breast cancer does not meet primary goal

ArQule's ARQ 197 Phase 1 clinical trial results in colorectal cancer presented at ASCO 2011

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

FDA establishes PDUFA date for ADVENTRX's Exelbine NDA review

Geron commences enrollment in imetelstat Phase 2 clinical trial in essential thrombocythemia

New long-term survival data from OPUS, CRYSTAL studies demonstrate strong tumor shrinkage of Erbitux

Pfizer initiates rolling submission of crizotinib NDA for ALK-positive advanced NSCLC

Daiichi Sankyo and ArQule initiate enrollment in ARQ 197 Phase 3 trial in NSCLC

Epigenetic therapy holds promise for cancer management

Cyclacel opens enrollment of sapacitabine Phase 3 trial for AML

Study supports use of telomerase inhibitors for treatment of childhood cancers

Oncolytics opens enrollment in REOLYSIN combination U.S. Phase I colorectal cancer study

FDA grants Exelixis XL184 orphan drug designation for treatment of medullary thyroid cancer

Infinity provides guidance on anticipated pipeline and business goals for 2011

Intrexon Corporation, ZIOPHARM enter partnership to develop, commercialize DNA-based therapeutics

Antigenics announces name change to Agenus

Sanofi-aventis announces publication of positive BSI-201 phase II results for breast cancer

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