MADRID and REDWOOD CITY, Calif, Sept. 28, 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, presented safety and efficacy data from two Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in pancreatic cancer and non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.
Results from the Phase 1b studies demonstrate that demcizumab, in combination with standard-of-care chemotherapy, is well tolerated, especially in patients where the company's risk mitigation, monitoring and truncated dosing strategies have been employed. Encouraging tumor response rates were presented at ESMO from a study of demcizumab with gemcitabine or gemcitabine plus Abraxane® (paclitaxel protein-bound particles for injectible suspension) (albumin bound) in patients with first-line pancreatic cancer, and from the study of demcizumab plus pemetrexed and carboplatin for the first-line treatment of Stage III/IV NSCLC. OncoMed's Phase 1b studies identified the demcizumab dosing schedules for the company's planned randomized Phase 2 proof-of-concept trials.
"As we advance to Phase 2 clinical trials of demcizumab, we have successfully identified strategies that result in both favorable tolerability and compelling response rates," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "To date, sixty-four patients have been enrolled and treated on the demcizumab truncated dosing schedule that will be used in our randomized Phase 2 studies. The majority of these patients have now been followed for greater than 100 days without any moderate-to-severe cardiopulmonary toxicities and a number of patients remain on treatment."
"Based on the data generated from our Phase 1b studies in pancreatic and non-small cell lung cancer we have identified a dosing regimen with impressive anti-tumor activity and an acceptable safety profile. We have confidence that these data enable the advancement of both programs into planned randomized Phase 2 studies in pancreatic cancer and NSCLC. Results from our Phase 1b demcizumab program not only signal the potential safety and anti-tumor activity for this drug, but also provide encouragement for the potential of an anti-cancer stem cell hypothesis," said Paul J. Hastings, Chairman and Chief Executive Officer.
Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=873324
OncoMed's Demcizumab Phase 1b Clinical Trials Show Encouraging Safety and Anti-Tumor Activity at ESMOResults Support Advancing Demcizumab Into Randomized Phase 2 Clinical Trials
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.
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.