REDWOOD CITY, Calif., March 17, 2016 (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 Phase 1b clinical trial of OncoMed's investigational agent demcizumab (anti-DLL4, OMP-21M18), with Merck's anti-Programmed Cell Death 1 (PD1) therapy pembrolizumab (KEYTRUDA®). The combination of these agents may act as a double blockade for cancer-induced immune suppression with potential application to a number of solid tumor cancers.
The Phase 1b clinical trial is enrolling patients with advanced or metastatic solid tumors to receive escalating dose cohorts of demcizumab plus an approved dose of pembrolizumab. Once an optimal combination dose is established, three expansion study cohorts will be enrolled in non-small cell lung cancer (NSCLC), anti-PD1 refractory solid tumors and castrate-resistant prostate cancer.
The primary objective of the trial is to determine the safety and tolerability of the demcizumab-pembrolizumab combination. The trial will also look at comparative pharmacokinetic profiles, incidence of antibodies against demcizumab or pembrolizumab, biomarker and immunological response, response rates and survival outcome in patients with advanced solid tumors, NSCLC, castrate-resistant prostate cancer and anti-PD1 antibody refractory cancers.
Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=961144
OncoMed Initiates Phase 1b Immuno-Oncology Combination Clinical Trial for Demcizumab and Pembrolizumab (anti-PD1)
Silk Road Medical Announces CE Mark Approval and First Patients Treated with the Next Generation ENROUTE® Transcarotid Neuroprotection System
Via: PR Newswire
SUNNYVALE, Calif., March 15, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced CE Mark approval for its next generation ENROUTE Transcarotid Neuroprotection System (NPS). The ENROUTE NPS remains the only device specifically designed and indicated for TransCarotid Artery Revascularization (TCAR), a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke.
Remedy Pharmaceuticals Appoints Thomas MacAllister as Vice President of Research and Development and General Counsel
Via: Business Wire
NEW YORK--(BUSINESS WIRE)--Remedy Pharmaceuticals, a privately-held, Phase 3-ready pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced that the Company appointed Thomas MacAllister as Vice President of Research and Development, and General Counsel.
OncoMed Pharmaceuticals Announces Full Year and Fourth Quarter 2015 Financial Results and 2016 Guidance
Projects Two Years' Cash Runway — without Partner-related Milestones/Opt-ins
Remedy Pharmaceuticals Announces Successful Completion of End-of-Phase 2 Meeting with FDA On A Novel Drug Treatment For CNS-Related Edema
NEW YORK, New York, March 4, 2016 — Remedy Pharmaceuticals, a privately-held, pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which took place on March 2, 2016.
Remedy Pharmaceuticals Announces Additional Results From Phase 2 CNS-Related Edema Study of CIRARA™ Presented at International Stroke Conference
Via: Yahoo! Finance
A more than three-fold reduction in mortality in patients ≤70 years old; adjudicated neurological mortality reduced more than three-fold, and death from edema reduced 10-fold.
Higher Doses of Tarextumab Appear to Correlate with Improved Progression-free and Overall Survival
Via: Clinton Foundation
By Chelsea Clinton, Vice Chair of the Clinton Foundation
Remedy Pharmaceuticals Announces Acceptance of Two Oral Presentations on Phase 2 Results of CIRARA™ for CNS-Related Edema at ISC 2016
Via: Yahoo! Finance
NEW YORK, Feb. 08, 2016 (GLOBE NEWSWIRE) -- Remedy Pharmaceuticals, a privately-held, phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced that results from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in large ischemic strokes will be presented during two oral presentations at the upcoming International Stroke Conference (ISC) 2016, being held February 17-19, 2016 at the Los Angeles Convention Center in Los Angeles, California.
Phase 2 PINNACLE Study in Small Cell Lung Cancer Continues Following DSMB and FDA Review