REDWOOD CITY, Calif., Aug. 28, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), announced today that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on enrollment in the company's vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials. Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols.

"We are pleased by the FDA's action to allow the resumption of enrollment in the vantictumab clinical trials," said Jakob Dupont, MD, OncoMed's Chief Medical Officer. "Patient safety is our top priority. The revised protocols were developed with input from the vantictumab clinical investigators and academic bone experts and are intended to mitigate the risks of future adverse events as we seek an optimal efficacious dose to take forward in the development of this first-in-class WNT pathway inhibitor."

The partial clinical hold occurred on July 1, 2014 following the company's voluntary halt to its Wnt pathway programs due to observed on-target mild-to-moderate bone-related adverse events. The FDA removed the partial clinical hold to permit the enrollment of vantictumab clinical trials following its review of a substantial clinical safety and efficacy data package and revised study protocols submitted by the company. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.

"The diligence and dedication of OncoMed's clinical development team to temporarily halt the vantictumab studies and submit a comprehensive response to the FDA has led to a prompt action by the agency," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. "We look forward to proceeding with the vantictumab Phase 1b clinical studies, and to the potential opt in by our partner Bayer based on data from these trials, to realize the future potential of this novel first-in-class WNT pathway inhibitor."


Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=868147

About half of all strokes could be caused by a narrowing of the carotid artery – the pipeline that ushers blood flow through the neck and to the brain. The Bay Area’s Silk Road Medical may have found a less-invasive way to increase the blood flow to the brain, using traditional stenting concepts but kicking ‘em up a notch.

To do so, Silk Road has just raised $15 million from four investors as part of a $22.5 million round, according to regulatory filings. This brings total investment in the company, founded in 2007, to more than $50 million. The company has listed Warburg Pincus and The Vertical Group as its main investors, though more are clearly involved.

The company has got a “transcarotid stent” that’s equipped with what’s called dynamic flow reversal, a mechanism that protects the brain by temporarily redirecting blood flow away from the brain while the stent is being inserted. It also carries away debris that’s inadvertently created during the procedure, Silk Road said, trapping it in a filter outside the body.

Read more: http://medcitynews.com/2014/08/silk-road-medical-raising-22-5-million-less-invasive-stroke-preventing-stent/#ixzz3B4aylzLz

REDWOOD CITY, Calif., Aug. 7, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today reported financial results and reviewed corporate events for the quarter ended June 30, 2014.

"We continue to execute on our research and development objectives, advancing our product candidates and building our portfolio of proprietary and innovative discovery programs," said OncoMed's Chairman and Chief Executive Officer, Paul J. Hastings. "The recent start of the Phase 2 ALPINE trial of tarextumab in pancreatic cancer represents an important milestone for the company, and we expect further pipeline progress and presentations of clinical and preclinical data in the second half of 2014."

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-announces-second-quarter-123000459.html