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FDA accepts Sangamo's IND for repeat-dosing in Phase 1 clinical trial of SB-728-T ZFN-based therapeutic

Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that the US Food and Drug Administration (FDA) has reviewed and accepted an Investigational New Drug (IND) application to initiate an open-label, repeat-dosing Phase 1 clinical trial (SB-728-T-902) of the company's ZFN-based therapeutic, SB-728-T. A single dose Phase 1 clinical study of SB-728-T was initiated in February 2009 and is ongoing at the University of Pennsylvania.

23 Sep 2009

Pluristem commences dosing in Phase I clinical trial for the treatment of critical limb ischemia

Pluristem Therapeutics Inc. (NasdaqCM: PSTI; DAX: PJT) today announced the dosing of the first patient in the U.S. with its placenta-derived stem cell product, PLX-PAD, the Company’s leading candidate, in a Phase I clinical trial for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

23 Sep 2009

Phase 2 trial results of Bayer's Nexavar in combination with capecitabine announced

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar(R) (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer.

23 Sep 2009

Phase 1b interim clinical trial results of IMO-2055, Tarceva and Avast combination announced

Idera Pharmaceuticals (Nasdaq: IDRA) today presented interim data from a phase 1b, single arm clinical trial evaluating IMO-2055, an agonist of Toll-like Receptor (TLR) 9, in combination with Tarceva® and Avastin® in patients with non-small cell lung cancer (NSCLC).

23 Sep 2009

Phase 1 extension study results of Plexxikon's PLX4032 in metastatic melanoma patients encouraging

Plexxikon Inc. today announced encouraging clinical data from a Phase 1 extension study of PLX4032 (RG7204) in metastatic melanoma patients, which expand the results announced from the initial phase of the study. PLX4032 is a novel, oral and highly selective drug that targets the BRAFV600E cancer-causing mutation that occurs in about 50 percent of melanomas and about eight percent of all solid tumors.

23 Sep 2009

Drug trial for OSI-906 begins

TGen Clinical Research Services at Scottsdale Healthcare today announced the start of a clinical trial for a drug designed to combat adrenocortical carcinoma (ACC), a rare but deadly cancer that attacks the adrenal glands.

23 Sep 2009

CERE-110 trial to stop the progression of Alzheimer's disease

Researchers in the Memory Disorders Program at Georgetown University Medical Center are now recruiting volunteers for a national gene therapy trial - the first study of its kind for the treatment of patients with dementia due to Alzheimer's disease.

23 Sep 2009

BioMarin commences PEG-PAL Phase 2 clinical trial for phenylketonuria

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the first patient has initiated treatment in the Phase 2 clinical study of PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase) for the treatment of phenylketonuria (PKU). Initial top-line results are expected in mid-2010.

23 Sep 2009

Amgen announces results of Phase 3 head-to-head trial evaluating denosumab versus Zometa

Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,046 patients with advanced breast cancer that met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa.

22 Sep 2009

NicOx announces publication of blood pressure results from the phase 3 study of naproxcinod

NicOx S.A. (NYSE Euronext Paris: COX) today announced that an important scientific article has been published in the September issue of the American Journal of Cardiology. The publication describes the blood pressure results from the 301 phase 3 study for naproxcinod in detail. Naproxcinod is the first-in-class Cyclooxygenase-Inhibiting Nitric Oxide Donating (CINOD) anti-inflammatory agent for the relief of the signs and symptoms of osteoarthritis (OA).

22 Sep 2009

Researchers to present results of HORIZONS-AMI trial at TCT scientific symposium

Two subset analyses from the landmark HORIZONS-AMI trial show that the anticoagulant bivalirudin lowers major bleeding and cardiac death versus the combination of heparin and a GP IIb/IIIa inhibitor in patients with ST-segment myocardial infarction (STEMI) who have disease of the left anterior descending artery (LAD), while in STEMI patients at highest risk for death, bivalirudin also confers the greatest mortality benefit.

22 Sep 2009

IRSF announces funding of new clinical study with disease-modifying therapy treatment for Rett syndrome

Today, the International Rett Syndrome Foundation announced that it will provide $200,000 in 2009 to support a newly proposed clinical trial with a growth-factor based treatment for Rett Syndrome. The study will be carried out by a team of clinical trials specialists at the Boston Children's Hospital, led by Dr. Omar Khwaja MD, PhD and will be the first potentially disease modifying therapy ever to be tested in Rett syndrome patients.

22 Sep 2009

Amgen announces Phase 3 results evaluating Vectibix in combination with FOLFIRI chemotherapy

Amgen (Nasdaq: AMGN) today announced detailed results from the Phase 3 '181' trial evaluating Vectibix((R)) (panitumumab) in combination with FOLFIRI (an irinotecan based chemotherapy), as a second-line treatment for metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved progression-free survival (PFS) in patients with KRAS wild-type mCRC.

22 Sep 2009

Bayer's regorafenib showed 50% stabilization rate in RCC patients

Bayer today announced results from a Phase II trial of regorafenib (BAY 73-4506), a potent oral multi-kinase inhibitor, which demonstrated that treatment with regorafenib resulted in a 31 percent partial response rate and 50 percent stabilization rate in patients with metastatic renal cell carcinoma (RCC).

22 Sep 2009

Interim data from Micromet's T-cell engaging BiTE antibody study for treating solid tumors

Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today presented first interim data from a phase 1 dose-escalation clinical study for BiTE antibody MT110, the first T-cell engaging antibody for the treatment of solid tumors.

22 Sep 2009

Vitae Pharmaceuticals initiates Phase 1 clinical trial of its novel cardiovascular agent

Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has initiated a Phase 1 clinical trial of its novel cardiovascular agent, VTP-27999.

21 Sep 2009

Provectus' Phase 2 clinical trial of PV-10 for metastatic melanoma complete

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical trial of PV-10 for metastatic melanoma. The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma.

21 Sep 2009

Enzo Biochem and NEI join to conduct a human clinical trial of Enzo’s chronic autoimmune uveitis therapeutic

Enzo Biochem, Inc. (NYSE: ENZ), announced today that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Eye Institute, part of the National Institute of Health, to conduct a human clinical trial of Optiquel™, Enzo’s oral, proprietary therapeutic for chronic autoimmune uveitis.

21 Sep 2009

Clinical trial results of topical INCB18424 inhibitor announced by Incyte Corporation

Incyte Corporation (Nasdaq:INCY) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis.

21 Sep 2009

Anavex completes manufacturing of Alzheimer's disease drug ANAVEX 2-73 for its clinical trials

Anavex Life Sciences Corp., ("ANAVEX") (OTCBB: AVXL) today announced the completion of scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.

21 Sep 2009

Drug Trial News

FDA accepts Sangamo's IND for repeat-dosing in Phase 1 clinical trial of SB-728-T ZFN-based therapeutic

Pluristem commences dosing in Phase I clinical trial for the treatment of critical limb ischemia

Phase 2 trial results of Bayer's Nexavar in combination with capecitabine announced

Phase 1b interim clinical trial results of IMO-2055, Tarceva and Avast combination announced

Phase 1 extension study results of Plexxikon's PLX4032 in metastatic melanoma patients encouraging

Drug trial for OSI-906 begins

CERE-110 trial to stop the progression of Alzheimer's disease

BioMarin commences PEG-PAL Phase 2 clinical trial for phenylketonuria

Amgen announces results of Phase 3 head-to-head trial evaluating denosumab versus Zometa

NicOx announces publication of blood pressure results from the phase 3 study of naproxcinod

Researchers to present results of HORIZONS-AMI trial at TCT scientific symposium

IRSF announces funding of new clinical study with disease-modifying therapy treatment for Rett syndrome

Amgen announces Phase 3 results evaluating Vectibix in combination with FOLFIRI chemotherapy

Bayer's regorafenib showed 50% stabilization rate in RCC patients

Interim data from Micromet's T-cell engaging BiTE antibody study for treating solid tumors

Vitae Pharmaceuticals initiates Phase 1 clinical trial of its novel cardiovascular agent

Provectus' Phase 2 clinical trial of PV-10 for metastatic melanoma complete

Enzo Biochem and NEI join to conduct a human clinical trial of Enzo’s chronic autoimmune uveitis therapeutic

Clinical trial results of topical INCB18424 inhibitor announced by Incyte Corporation

Anavex completes manufacturing of Alzheimer's disease drug ANAVEX 2-73 for its clinical trials

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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