Data Supports Phase 2 ALPINE Study of Tarextumab in Pancreatic Cancer and Phase 2 PINNACLE Trial in Small Cell Lung Cancer

MADRID and REDWOOD CITY, Calif., Sept. 29, 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 promising data on safety and anti-tumor activity from the ALPINE and PINNACLE Phase 1b clinical studies of tarextumab (anti-Notch2/3, OMP-59R5) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

"The Phase 1b tarextumab data presented at ESMO 2014 support our randomized Phase 2 clinical programs with this novel antibody targeting the Notch pathway," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "In the ALPINE study of patients with pancreatic cancer, we are seeing promising anti-tumor activity and tolerability in combination with standard of care. Notably, we now have pharmacodynamic evidence of Notch pathway inhibition, which provides clinical validation that tarextumab is hitting its desired target. In our PINNACLE trial of small cell lung cancer patients, we have seen a number of partial responses and tarextumab has been well tolerated in combination with standard platinum and etoposide chemotherapy."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=873389

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. 


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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

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.

Prior to joining Silk Road Medical, Michael was the Vice President of Research and Development at Boston Scientific's Electrophysiology Division and previously held senior technical leadership roles at Baxano Surgical, Inc., BARRx Medical, and Boston Scientific Neurovascular / Target Therapeutics. He has over 20 years of experience in the medical device field and holds over 120 issued or pending US patents.

Read More: http://www.prnewswire.com/news-releases/silk-road-medical-appoints-ground-breaking-innovator-as-chief-technology-officer-268257952.html

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.

Tarextumab is being tested in combination with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival (PFS) of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-initiates-randomized-phase-123000405.html

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.

The carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. Plaque formation in these arteries can put patients at risk for stroke. Stroke is the nation's third leading cause of death, killing nearly 160,000 Americans every year.  Approximately 130,000 Americans are treated for narrowing of the carotid arteries each year. 

Read More: http://www.prnewswire.com/news-releases/silk-road-medical-completes-enrollment-in-the-roadster-clinical-trial-for-carotid-artery-disease-267377181.html

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).

“The NACDD’s endorsement of Prevent is a tremendous validation of how digital therapeutics can revolutionize behavioral medicine and help combat chronic disease at scale”

The mission of the NACDD is to work with public health departments, associations and private partners across the United States to prevent and control chronic disease. One of NACDD’s areas of focus is the prevention of type 2 diabetes. People with diagnosed diabetes, on average, have medical expenditures approximately 2.3 times higher than those without diabetes. Thirty-seven percent of American adults have prediabetes (the clinical precursor to type 2 diabetes), and without lifestyle changes to improve their health, 15% to 30% of those will develop type 2 diabetes within five years.

Read More: http://www.businesswire.com/news/home/20140715006190/en/Omada-Health-Endorsed-National-Association-Chronic-Disease#.U8bQQvldWsA

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.

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-granted-broad-fzd-123000431.html