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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

MOH approves BrainStorm's NurOwn stem cell therapy for Phase I/II clinical trial

BrainStorm Cell Therapeutics Inc. a leading developer of adult stem cell technologies and therapeutics, today announced that the Israeli Ministry of Health (MOH) has granted clearance for a Phase I/II clinical trial using the company's autologous NurOwn stem cell therapy in patients with amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease.

11 Oct 2010

BioSante presents update on LibiGel clinical study at NAMS Annual Meeting

BioSante Pharmaceuticals, Inc. presented a LibiGel clinical study update at the 21st Annual Meeting of The North American Menopause Society (NAMS) on October 8, 2010, with more than 1,000 experts and practitioners in menopause and women's health in attendance.

11 Oct 2010

OXiGENE announces ZYBRESTAT Phase 2/3 study results at ESMO Congress

OXiGENE, a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that an ongoing analysis of positive results reported earlier from a randomized, controlled, Phase 2/3 study of ZYBRESTAT (fosbretabulin, CA4P) were presented today at the 35th European Society of Medical Oncology (ESMO) Congress in Milan, Italy by Julie Ann Sosa, M.D., F.A.C.S., of Yale University.

11 Oct 2010

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

A Novartis Pharmaceuticals Corporation Phase III study of Afinitor® (everolimus) tablets in combination with Sandostatin® LAR Depot (octreotide acetate for injectable suspension) extended median progression-free survival (PFS), or time without tumor growth, in patients with advanced carcinoid tumors compared to taking octreotide LAR alone.

11 Oct 2010

Combination of MET and erlotinib delays lung cancer progression: Study

A subset of lung cancer patients seem to live longer and experience delays in disease progression when a new drug that targets a cancer-associated molecule called MET is added to treatment with erlotinib, the results of a double-blind Phase-II trial show.

11 Oct 2010

Promising clinical data of ImmunoGen's lorvotuzumab mertansine to be presented at ESMO conference

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics using its Targeted Antibody Payload (TAP) technology, today announced the presentation of encouraging clinical data for the Company's lorvotuzumab mertansine (IMGN901) targeted anticancer compound at the 35th European Society for Medical Oncology (ESMO) Conference being held in Milan, Italy, October 8-12, 2010.

11 Oct 2010

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

Seattle Genetics, Inc. and Millennium The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced positive top-line results from a phase II clinical trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 58 relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients.

11 Oct 2010

Seattle Genetics reports SGN-75 phase I clinical trial data

Seattle Genetics, Inc. today reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing.

11 Oct 2010

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the first subject has been dosed in the global phase III program of XIAFLEX® for the treatment of Peyronie's disease. Peyronie's disease is the development of scar tissue on the penis that can cause the penis to curve during erection, often interfering with or preventing intercourse and resulting in psychological distress or bother for the patient.

11 Oct 2010

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

BiondVax Pharmaceuticals Ltd., an Israeli biopharmaceutical company at the forefront of global efforts towards the development of a Universal Influenza Vaccine, today announced that it has begun to immunize subjects in a Phase IIa clinical trial of the Multimeric-001 Universal Flu Vaccine candidate. The study will evaluate the safety and immunogenicity of the Multimeric-001 vaccine.

11 Oct 2010

Phase-II clinical trial of MLN8237 drug shows promising results for treating ovarian cancer

A drug being developed as a treatment for ovarian cancer has shown single agent activity with durable disease control in some patients in a Phase-II clinical trial, an international research group has reported.

11 Oct 2010

First-line treatment with erlotinib drug improves progression-free survival in patients with advanced lung cancer

For patients with advanced lung cancer whose tumors carry EGFR activating mutations, first-line treatment with erlotinib nearly tripled progression-free survival compared to a standard chemotherapy combination, show results from the first prospective Phase-III study to report findings in this setting.The new results from the OPTIMAL trial were reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.

11 Oct 2010

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

Infinity Pharmaceuticals, Inc. today announced promising preliminary results from a Phase 1 study of IPI-926, its novel, oral small molecule that targets the Hedgehog pathway.

11 Oct 2010

Anti-HER2 antibody-drug conjugate effective as first-line therapy for advanced breast cancer: Research

A new type of breast cancer treatment has shown encouraging activity as a first-line therapy in HER2-positive metastatic disease, researchers reported at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy.

11 Oct 2010

Phase I study of Shigella dysenteriae bioconjugate vaccine meets primary, secondary endpoints

GlycoVaxyn AG, a leader in the development of innovative vaccines, announced today that the Phase I study of its Shigella dysenteriae bioconjugate vaccine has been completed and met the primary and secondary endpoints: demonstration of safety and immunogenicity.

8 Oct 2010

Drug Trial News

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

MOH approves BrainStorm's NurOwn stem cell therapy for Phase I/II clinical trial

BioSante presents update on LibiGel clinical study at NAMS Annual Meeting

OXiGENE announces ZYBRESTAT Phase 2/3 study results at ESMO Congress

Afinitor-Sandostatin LAR Depot combination extends median PFS in patients with advanced carcinoid tumors

Combination of MET and erlotinib delays lung cancer progression: Study

Promising clinical data of ImmunoGen's lorvotuzumab mertansine to be presented at ESMO conference

Millennium, Seattle Genetics announce positive top-line results of SGN-35 phase II clinical trial

Seattle Genetics reports SGN-75 phase I clinical trial data

Auxilium commences dosing in global XIAFLEX phase III program for Peyronie's disease

BiondVax commences Multimeric-001 flu vaccine Phase IIa clinical study

Phase-II clinical trial of MLN8237 drug shows promising results for treating ovarian cancer

First-line treatment with erlotinib drug improves progression-free survival in patients with advanced lung cancer

Infinity announces preliminary results of IPI-926 Phase 1 study in patients with solid tumors

Anti-HER2 antibody-drug conjugate effective as first-line therapy for advanced breast cancer: Research

Phase I study of Shigella dysenteriae bioconjugate vaccine meets primary, secondary endpoints

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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