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. 

Results Provide Additional Basis for Planned U.S. Phase 3 Trial in Large Hemispheric Stroke

NEW YORK, Feb. 22, 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 additional efficacy data from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in patients with large hemispheric stroke. The results were presented by the study’s two principal investigators, Kevin N. Sheth, MD of Yale University and W. Taylor Kimberly, MD of Massachusetts General Hospital, in two oral presentations during the International Stroke Conference (ISC) 2016, held February 17-19, 2016 at the Los Angeles Convention Center in Los Angeles, California.

CIRARA is the Company’s lead product candidate for the treatment of CNS-related edema. The GAMES-RP study was a prospective double-blind, randomized, placebo-controlled Phase 2 trial comparing CIRARA to placebo. Top line results had previously been presented at the Neurocritical Care Society annual general meeting in October 2015 and announced by Remedy in a press release.
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The additional analyses presented at ISC included adjudicated mortality, 6-month functional outcome data, and a post hoc analysis in patients 70 years or younger.

Read More: http://finance.yahoo.com/news/remedy-pharmaceuticals-announces-additional-results-123000039.html

Higher Doses of Tarextumab Appear to Correlate with Improved Progression-free and Overall Survival

REDWOOD CITY, Calif., Feb. 22, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, announced updated survival data from a Phase 1b clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of small cell lung cancer.
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The Phase 1b dose-escalation trial enrolled 27 previously untreated patients with extensive-stage small cell lung cancer to assess the safety, biomarker, and anti-tumor activity of tarextumab in combination with etoposide and platinum-based chemotherapy.  Doses of tarextumab ranged from 5 mg/kg to 15 mg/kg and a Phase 2 combination dose of 15mg/kg every three weeks was selected.  Among all patients in the trial, median progression-free survival (PFS) was 4.4 months and the median overall survival (OS) was 10.3 months.  Additional survival benefit was observed in 15 patients who received higher doses of tarextumab (at or above 12.5 mg/kg every three weeks) in combination with standard-of-care therapy, with a median PFS of 5.8 months and median OS of 16 months. 

"These more mature follow-up data from our Phase 1b trial of tarextumab plus chemotherapy in small cell lung cancer patients provide early signs of encouraging efficacy.  Of note, we are seeing a dose-efficacy association with a manageable side effect profile for tarextumab in the small cell lung cancer Phase 1b clinical trial.  This Phase 1b data supports our ongoing Phase 2 PINNACLE trial," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer.  "Small cell lung cancer responds quickly to chemotherapy, but has a high rate of recurrence.  By targeting cancer stem cells, and Notch3 in particular, we hope to have a positive impact on patient outcomes."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=956052

By Chelsea Clinton, Vice Chair of the Clinton Foundation

Just a few weeks ago, the Clinton Foundation hosted its fifth annual Health Matters Activation Summit, where 450 of the top health industry leaders from around the United States advanced the national conversation on how to improve access to healthcare at the systemic level, with a focus on our communities.
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Every year, at the Summit we bring people together who are invested in the health of others and their communities to discuss the data, science, and trends so we can identify how we do more. At this year’s Summit, many of our conversations included and highlighted young industry leaders who are playing a greater role than ever in the discussions and solutions, reflecting a larger trend that has us at the Clinton Foundation excited. Through the Foundation’s various initiatives — including the students who gather each year for Clinton Global Initiative University (CGI U) — we have seen, heard and supported young social entrepreneurs drive some of the social sector’s most promising efforts to reduce health disparities around the world.

I am inspired by the next generation of innovators who participated in the Health Matters Summit and are implementing their forward-looking ideas. I wish I had gotten to meet them all! Keep an eye out for these three, who are working hard to transform the health landscape as we know it. 
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Sean Duffy: Addressing Chronic Disease Through Digital TherapeuticsSean Duffy often thinks about the future of health. And through Omada Health, he’s trying to shape it.

Omada Health is a pioneer in a budding field of medicine that the company terms digital therapeutics. Whereas behavioral health interventions for preventable diseases have traditionally been given face to face, Sean’s company is leveraging digital technology to deliver these programs to patients’ homes. The program Prevent, for example, helps people reduce their risk for type 2 diabetes over the course of 16 weeks through resources such as a health coach, tools to monitor food intake, and support from peers around the clock — all offered digitally. The medical student-turned-CEO is working to create a world where people at risk for diabetes can turn to their tablets for a healthcare experience that is just as effective as a trip to the doctor.

Read More: https://medium.com/@ClintonFdn/meet-3-young-leaders-who-are-transforming-the-health-industry-d002b486a916#.mjlz1v55v

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.
The two oral presentations will be conducted by principal investigators and leading neuroscience researchers at Yale University and Massachusetts General Hospital.
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“We are thrilled to have this exciting data presented to a group of illustrious clinicians at the world’s largest and most prestigious medical meeting dedicated to the science and treatment of cerebrovascular disease,” commented Sven Jacobson, CEO of Remedy Pharmaceuticals. “Edema is one of the most significant mortality risks associated with stroke and other acute CNS conditions. In fact, in the first week following an ischemic stroke, 78% of all deaths are attributable to edema and in hemorrhagic stroke, 93% of deaths are caused by this type of swelling. CNS edema continues to be a condition characterized by major unmet medical need. We look forward to sharing the full results of the Phase 2 trial evaluating CIRARA for reduction of the devastating consequences associated with edema after a severe stroke.”

Read More: https://beta.finance.yahoo.com/news/remedy-pharmaceuticals-announces-acceptance-two-143556262.html

Phase 2 PINNACLE Study in Small Cell Lung Cancer Continues Following DSMB and FDA Review

REDWOOD CITY, Calif., Feb. 08, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, announced updates on the tarextumab (anti-Notch 2/3, OMP-59R5) Phase 2 programs in pancreatic cancer (the "ALPINE" study) and small cell lung cancer (the "PINNACLE" study).  OncoMed will continue the PINNACLE Phase 2 trial of tarextumab in small cell lung cancer following a review of unblinded safety and efficacy data from both the ALPINE and PINNACLE studies by the U.S. Food and Drug Administration (FDA) and the PINNACLE Data Safety Monitoring Board (DSMB).  The PINNACLE study remains blinded to OncoMed, investigators and patients.  OncoMed has discontinued dosing of tarextumab in the Phase 2 ALPINE clinical study. 
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"After communicating with the FDA and the PINNACLE trial DSMB we have received feedback that appropriate safety monitoring is in place to continue the PINNACLE trial," said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed.  "While we remain blinded to the PINNACLE trial data, differences in pancreatic and small cell lung cancer biology, combined with our understanding of the potential mechanisms of tarextumab, give us confidence to continue the PINNACLE Phase 2 clinical trial."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=953725