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
Via: Med City News
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.
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.
SUNNYVALE, Calif., July 23, 2014 /PRNewswire/ -- Silk Road Medical, Inc., a developer of advanced devices for the transcarotid treatment of intra- and extra-cranial cerebrovascular disease, announced today the appointment of Michael P. Wallace to the position of Chief Technology Officer. In this new role, Michael will lead the company's Research and Development efforts across its family of transcarotid access and treatment devices.
OncoMed Pharmaceuticals Initiates Randomized Phase 2 "ALPINE" Clinical Trial of Tarextumab (Anti-Notch 2/3, OMP-59R5) for Pancreatic Cancer
REDWOOD CITY, Calif., July 16, 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 announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE" (Antibody therapy in first-LinePancreatic cancer Investigating anti-Notch Efficacy and safety) clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), being studied for the treatment of pancreatic cancer.
SUNNYVALE, Calif., July 16, 2014 /PRNewswire/ -- Silk Road Medical, Inc. announced today the completion of enrollment in its pivotal ROADSTER study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure. The device under study is the Company's ENROUTE™ Transcarotid Neuroprotection System (NPS) which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow. Data from the trial will be used to support 510(k) clearance of the ENROUTE Transcarotid NPS as well as PMA approval of the ENROUTE Transcarotid Stent System.
Omada Health Endorsed by the National Association of Chronic Disease Directors as a Premier Online Provider for Patients Seeking the Diabetes Prevention Program (DPP)
Via: Business Wire
SAN FRANCISCO--(BUSINESS WIRE)--Omada Health, a pioneer in the emerging field of digital therapeutics, today announced the National Association of Chronic Disease Directors (NACDD) has selected its flagship product, Prevent, an online program to fight prediabetes, as a premier solution for patients seeking an online Diabetes Prevention Program (DPP).
REDWOOD CITY, Calif., July 2, 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 announced the issuance of a broad U.S. patent relating to FZD-Fc soluble receptors, including OncoMed's clinical-stage candidate ipafricept (FZD8-Fc, OMP-54F28). The new patent, U.S. Patent No. 8,765,913, includes claims covering certain FZD-Fc compositions of matter, as well as claims covering methods of treating cancer with such soluble receptors. Polynucleotides encoding the claimed FZD-Fc polypeptides and cells producing such polypeptides are also covered.
MINNEAPOLIS, June 17, 2014 /PRNewswire/ -- Techne Corporation TECH +2.06% (d/b/a Bio-Techne) announced today that it has agreed to acquire ProteinSimple for $300 million in cash. The closing of the acquisition is subject to the satisfaction of customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The acquisition is not subject to any financing contingencies. The transaction will be financed through a combination of cash on hand and a new revolving line of credit facility that Bio-Techne expects to obtain prior to the closing of the acquisition.
REDWOOD CITY, Calif., June 4, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, will present new data at the upcoming 19th European Hematology Association (EHA) Congress related to the company's anti-Notch1 (OMP-52M51) clinical-stage program.