Enrollment of 177 Patients Completed Over Eight Months Ahead of Schedule
REDWOOD CITY, Calif., Aug. 31, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced that it has completed patient enrollment in its Phase 2 "ALPINE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of pancreatic cancer more than eight months ahead of schedule. The ALPINE study enrolled 177 patients with advanced pancreatic cancer who had not received prior treatment. Enrollment in the randomized, double-blinded, multi-center clinical study began in July 2014.
"We are encouraged to have accrued patients in this expanded trial over eight months ahead of our original projections and by the enthusiasm of theALPINE investigators for the potential of tarextumab in combination with chemotherapy for the treatment of patients with pancreatic cancer," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "The ALPINE clinical study will be the first of our ongoing Phase 2 trials testing novel anti-cancer stem cell therapeutics to read out, and we expect to report data from this trial in the second half of 2016. The primary endpoint of the study is overall survival."
The Phase 2 ALPINE trial is designed to evaluate the efficacy of tarextumab in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. The Phase 2 clinical trial will compare the overall survival of patients receiving tarextumab 15 mg/kg every two weeks versus placebo in combination with Abraxane plus gemcitabine. Secondary and exploratory endpoints, including progression-free survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated. Overall survival, progression-free survival and overall response rates will be assessed using a predictive biomarker for high tumor Notch3 expression. Increased Notch3 expression is estimated to occur in approximately 70 percent of pancreatic tumors and is associated with poor patient outcomes.
Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=929392
OncoMed Pharmaceuticals Completes Enrollment of Phase 2 ALPINE Clinical Trial of Tarextumab in Pancreatic Cancer
REDWOOD CITY, Calif., July 28, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in its anti-RSPO3 antibody (OMP-131R10) Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers.
We caught up with leading founders in digital health to tap their insider expertise on everything you need to know about building a company in healthcare—from recruiting top talent and building a company on human-centered design principles to hospital sales and putting your customers first. Here are the four newest installments in our Startup Elements series:
Sean Duffy, cofounder and CEO of Rock Health portfolio company Omada Health discusses how the company shapes their internal and external practices around human-centered design principles.
Via: Mass Device
Outset Medical, previously Home Dialysis Plus, said it raised $91 million in a new funding round, with $51 million in equity and $40 million in debt funding. Funds are slated to continue development and promotion of its Tablo all-in-one dialysis system.
Dialysis player Outset Medical attracted a lot of media attention last month when it released an SEC filing for a $60 million equity financing. Now, it's ready to give a much more detailed account of the financing and the plans for its Tablo product, which it touts as the first consumer-friendly, all-in-one dialysis device to get through the FDA.
OncoMed and Lilly Enter Clinical Supply Agreement to Evaluate the Combination of Demcizumab and Alimta(R) (pemetrexed for injection) in Lung Cancer
REDWOOD CITY, Calif., April 2, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced today that it has entered into an agreement with Eli Lilly and Company. Demcizumab, OncoMed's anti-DLL4 antibody, is being tested in combination with Lilly's Alimta® (pemetrexed for injection) and carboplatin for the treatment of first-line advanced non-small cell lung cancer (NSCLC). Under the terms of this agreement, Lilly will provide clinical supply of Alimta for OncoMed's ongoing Phase 2 DENALI trial.
OncoMed to Present Data on Multiple Anti-Cancer Stem Cell Candidates at the American Association of Cancer Research Meeting
REDWOOD CITY, Calif., March 19, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED) will present new data related to its clinical and preclinical anti-cancer stem cell and immuno-oncology candidates in a total of seven presentations at the upcoming American Association of Cancer Research (AACR) Meeting to be held April 18-22, 2015 in Philadelphia, PA.
Silk Road Medical Announces FDA 510(k) Clearance of the ENROUTE® Transcarotid Neuroprotection System
Via: PR Newswire
Novel system to protect against stroke via direct carotid access and robust blood flow reversal initiates a new era in carotid revascularization
Direct access stenting of the carotid artery shows promising results, especially for patients with difficult anatomy at high-risk for both surgery and transfemoral carotid artery stenting (CAS), according to data presented February 3, 2015, at the International Symposium on Endovascular Therapy in Hollywood, FL.
OncoMed Initiates Dosing in Phase 2 Clinical Trial of Demcizumab for the Treatment of Non-Small Cell Lung Cancer
REDWOOD CITY, Calif., Feb. 4, 2015 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the double-blinded, placebo-controlled, randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of patients with first-line advanced-stage non-small cell lung cancer (NSCLC).