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Helix completes GLP toxicology study milestone in L-DOS47 development program

Helix BioPharma Corp. today announced that it has completed its definitive GLP, rodent and primate, repeat-dose toxicology studies with L-DOS47. These studies demonstrated a good safety profile in an expanded number of rodent and primate test animals, building upon Helix's positive findings from its preliminary non-GLP toxicology studies.

12 Oct 2010

UCB, Synosia Therapeutics announce new strategic partnership in neurology

UCB and Synosia Therapeutics announced today a new strategic partnership in neurology. Synosia has granted UCB a license for exclusive, worldwide rights to the development compound SYN-115 and rights to a second compound, SYN-118, for non-orphan indications. Both are in Phase II clinical development for the treatment of Parkinson's disease.

12 Oct 2010

Halozyme Therapeutics to advance core proprietary programs through key clinical inflection points

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced a focusing of its resources on advancing its core proprietary programs through key clinical inflection points in 2011 and 2012, and supporting strategic alliances with Roche and Baxter such as validation of Halozyme's commercial scale manufacturing process to produce kilogram quantities of enzyme.

12 Oct 2010

Erbitux-based therapy helps in early tumor shrinkage, long-term survival in mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany has announced that new data presented today at the 35th Congress of the European Society for Medical Oncology (ESMO) have shown that patients with KRAS wild-type metastatic colorectal cancer (mCRC) who experienced early tumor shrinkage (within 8 weeks) during 1st line Erbitux (cetuximab) based treatment lived a median of 28.3 months.

12 Oct 2010

Early cancer drug trials flawed by inconsistencies in prohibited drug lists, study finds

Researchers in Canada and France have raised concerns about substantial inconsistencies in a basic aspect of the way Phase-I and Phase-II cancer clinical trials are designed.

11 Oct 2010

Access highlights clinical benefits of MuGard at ESMO conference

Access Pharmaceuticals, Inc., a biopharmaceutical company specializing in products for cancer and supportive care, announced the highlights from a poster presentation on European clinical experience of MuGard at this year's European Society of Medical Oncology Conference in Milan, Italy.

11 Oct 2010

Merck Serono announces first results from Erbitux BALI-1 study in metastatic triple-negative breast cancer

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the first results from the BALI-1 study of Erbitux® (cetuximab) in the treatment of metastatic triple-negative breast cancer (TNBC), an aggressive cancer in which early relapse and metastasis are common. The data, presented during the 35th Congress of the European Society for Medical Oncology (ESMO), demonstrate that Erbitux has the potential to improve outcomes for women with this relentlessly devastating cancer.

11 Oct 2010

Abbott presents data from 4 briakinumab pivotal studies in psoriasis

In four separate pivotal clinical studies presented on Friday, a greater percentage of moderate to severe chronic plaque psoriasis patients treated with briakinumab, Abbott's investigational IL-12/23 inhibitor (ABT-874), achieved 75 percent or better skin clearance rates than those treated with etanercept (Enbrel®), methotrexate or placebo. Abbott presented data from all briakinumab pivotal studies in psoriasis at the European Association of Dermatology and Venereology scientific sessions.

11 Oct 2010

Boehringer Ingelheim announces results from afatinib clinical trials at 35th ESMO

Boehringer Ingelheim Pharmaceuticals, Inc. announced today results from two clinical trials for its investigational cancer compound afatinib* (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

Results from a pre-specified interim analysis of a randomized, placebo-controlled Phase 3 study, COU-AA-301, demonstrate that patients treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo.

11 Oct 2010

ArQule announces SPA with FDA for ARQ 197 Phase 3 trial design for NSCLC

ArQule, Inc. today announced a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of a Phase 3 trial of ARQ 197 in patients with non-small cell lung cancer (NSCLC) of non-squamous histology.

11 Oct 2010

Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Innate Therapeutics today announced that the company has begun treating patients in a Phase 2a clinical study of its lead molecule, MIS416, in patients with progressive multiple sclerosis (MS).

11 Oct 2010

Genentech initiates GDC-0449 Phase II clinical trial in BCC patients

Curis, Inc. a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that its collaborator Genentech, a member of the Roche Group, has initiated a Phase II clinical trial of GDC-0449, an orally-administered small molecule Hedgehog Pathway Inhibitor, as a single-agent therapy for patients with operable basal cell carcinoma (BCC).

11 Oct 2010

Micromet to initiate MEDI-565 Phase 1 trial in patients with advanced gastrointestinal cancer

Micromet, Inc. today announced that its licensee for MT111, MedImmune, plans to initiate a Phase 1 trial in patients with advanced gastrointestinal cancers based on an investigational new drug (IND) application recently accepted by the U.S. Food and Drug Administration (FDA).

11 Oct 2010

AVEO presents tivozanib Phase 2 study results at ESMO Congress

AVEO Pharmaceuticals, Inc. a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) were presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

Geron commences GRNOPC1 hESC-based cell therapy in patients with spinal cord injury

Geron Corporation today announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1. The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries. Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

11 Oct 2010

ACT Biotech reports positive interim data from Telatinib Phase 2 trial for advanced gastric cancer

ACT Biotech Inc., a privately held biotechnology company based in San Francisco, California, today announced positive interim data from a Phase 2 trial of the Company's lead oral kinase inhibitor, Telatinib, for the first-line treatment of patients with advanced gastric cancer. This proof-of-concept, multi-center, open label trial was designed to test the efficacy and safety of full-dose Telatinib, administered continuously, as a first-line treatment in combination with a standard regimen of capecitabine and cisplatin in US and European patients.

11 Oct 2010

Eli Lilly presents ALIMTA Phase III trial results at ESMO Annual Meeting

Eli Lilly and Company announced today that its global Phase III trial evaluating ALIMTA (pemetrexed for injection) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (SCCHN) did not meet its primary endpoint for overall survival. Data were presented for the first time today at the 35th Annual Meeting of the European Society for Medical Oncology (ESMO).

11 Oct 2010

ArQule announces ARQ 197 Phase 2 clinical trial results at ESMO annual meeting

ArQule, Inc. today announced the presentation of final results from a Phase 2 clinical trial in non-small cell lung cancer (NSCLC) of ARQ 197, a selective small molecule inhibitor of the c-MET receptor tyrosine kinase, at the annual meeting of the European Society for Medical Oncology (ESMO).

11 Oct 2010

Allos announces favorable survival data from FOLOTYN Phase 2b study

Allos Therapeutics, Inc. today announced the presentation of favorable survival data from the Company's international, randomized Phase 2b investigational study of FOLOTYN relative to erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC). In this study, patients receiving FOLOTYN had a 16 percent reduction in the risk of death compared to erlotinib in the overall (intent-to-treat) population.

11 Oct 2010

Drug Trial News

Helix completes GLP toxicology study milestone in L-DOS47 development program

UCB, Synosia Therapeutics announce new strategic partnership in neurology

Halozyme Therapeutics to advance core proprietary programs through key clinical inflection points

Erbitux-based therapy helps in early tumor shrinkage, long-term survival in mCRC patients with KRAS wild-type tumors

Early cancer drug trials flawed by inconsistencies in prohibited drug lists, study finds

Access highlights clinical benefits of MuGard at ESMO conference

Merck Serono announces first results from Erbitux BALI-1 study in metastatic triple-negative breast cancer

Abbott presents data from 4 briakinumab pivotal studies in psoriasis

Boehringer Ingelheim announces results from afatinib clinical trials at 35th ESMO

COU-AA-301 Phase 3 study demonstrates improvement in CRPC survival rate

ArQule announces SPA with FDA for ARQ 197 Phase 3 trial design for NSCLC

Innate Therapeutics initiates MIS416 Phase 2a clinical study in patients with progressive multiple sclerosis

Genentech initiates GDC-0449 Phase II clinical trial in BCC patients

Micromet to initiate MEDI-565 Phase 1 trial in patients with advanced gastrointestinal cancer

AVEO presents tivozanib Phase 2 study results at ESMO Congress

Geron commences GRNOPC1 hESC-based cell therapy in patients with spinal cord injury

ACT Biotech reports positive interim data from Telatinib Phase 2 trial for advanced gastric cancer

Eli Lilly presents ALIMTA Phase III trial results at ESMO Annual Meeting

ArQule announces ARQ 197 Phase 2 clinical trial results at ESMO annual meeting

Allos announces favorable survival data from FOLOTYN Phase 2b study

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