REDWOOD CITY, Calif., Jan. 29, 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, today announced that the U.S. Food and Drug Administration's Office of Orphan Products Development (OOPD) has granted orphan drug designation to tarextumab (anti-Notch 2/3, OMP-59R5) for the treatment of both pancreatic cancer and small cell lung cancer.


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CNS-Related Edema Company Remedy Pharmaceuticals Strengthens Leadership Team in Preparation for Phase 3 Trial
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Remedy Pharmaceuticals, a clinical stage pharmaceutical company focused on the development and commercialization of an innovative central nervous system drug, CIRARA™, announced today that the Company strengthened its leadership team with the appointment of Ann Tunstall as Vice President of Regulatory and Operational Affairs, and Alan Cutler as Vice President of Chemistry Manufacturing and Controls.

"We’re excited to have Ann and Alan join our executive team,” commented Sven Jacobson, CEO of Remedy Pharmaceuticals. “They bring a wealth of experience and tremendous knowledge, which we believe will be a great asset to the company as we move closer to initiating our Phase 3 trial targeting brain swelling following severe stroke. We also look forward to their contributions as we accelerate our clinical trial efforts in other CNS conditions where swelling is an important determinant of outcome such as spinal cord injury, traumatic brain injury and subarachnoid hemorrhage.”

Read More: http://www.reuters.com/article/ny-remedy-pharmaceutical-idUSnBw055226a+100+BSW20160105

Evidence of Clinical Activity in Patients With Tumors Positive for Predictive Biomarkers of Notch1 Overexpression Using OncoMed's Immunohistochemistry Assay

BARCELONA, Spain and REDWOOD CITY, Calif., Nov. 19, 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 data today from the company's ongoing Phase 1a clinical trial of anti-Notch1 (OMP-52M51) in patients with certain advanced solid tumors during an oral plenary session at the 26thEORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.

The purpose of the anti-Notch1 Phase 1a clinical trial is to determine a maximum tolerated dose and to assess safety, pharmacokinetics, immunogenicity and preliminary efficacy in patients, including patients with tumors overexpressing the Notch1 target as measured by a predictive diagnostic test. Among 31 patients evaluable for safety, anti-Notch1 had a manageable safety profile. The most common adverse event was on-target diarrhea, which was treated with supportive care. A Phase 2 single-agent dose of 1.5 mg/kg every three weeks was established and will be used in an expansion cohort of the Phase 1a trial that will only enroll patients with tumors that overexpress Notch1 as measured by OncoMed's predictive biomarker assay.

"Encouraging data presented today highlight why we are enthusiastic about the anti-Notch1 clinical program. We have successfully identified a single-agent dose and schedule that shows a manageable safety profile as well as early signs of anti-tumor activity," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "OncoMed researchers have identified a number of tumor types where Notch1 may be contributing to tumor growth and progression. In this study, we are using a proprietary immunohistochemistry test to assess Notch1 activation status and correlating those results to the drug's activity. We are seeing early signs of anti-tumor activity in several patients, with the most impressive signals observed in patients whose tumors appear to overexpress the activated form of Notch1."


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ROADSTER pivotal results (presented by Christopher J. Kwolek, MD) In the recent CREST trial, transfemoral carotid artery stenting (CAS) showed an excess periprocedural stroke rate (4.1%) when compared to carotid endarterectomy (CEA) (2.3%), while CEA was shown to carry risks of surgical complications including cranial nerve injury (CNI) (4.8%). ROADSTER is a prospective, multicenter, investigational device exemption study designed to evaluate the safety and effectiveness of a novel hybrid carotid revascularization procedure using the ENROUTE transcarotid neuroprotection system (NPS) (Silk Road Medical, Inc.). The primary endpoint was a composite of any stroke (S), myocardial infarction (MI), or death (D) through 30 days. Symptomatic and asymptomatic patients who were at high risk for complications from CEA were eligible. Between November 2012 and July 2014, 208 patients (67 lead-in, 141 pivotal) were enrolled at 18 hospitals. FDA-approved carotid stent systems, chosen according to site preference, were delivered through the direct carotid access point under high-rate flow reversal afforded by the ENROUTE NPS. Baseline pivotal population characteristics included 26% symptomatic, 35% female, and 47% age 75 or older; 56% of patients had physiologic risk factors, and 69% had anatomic risks. In the intention to treat (ITT) population, the rates for S/D/MI, S/D, and any stroke were 3.5%, 2.8%, and 1.4%, respectively. In a per protocol (PP) analysis (n = 136), the outcomes were 2.9%, 2.2% and 0.7%, respectively. There were no strokes in patients age 75 or older, nor in symptomatic patients. Transient CNI at 30 days was 0.7% and fully resolved. The upper 95% confidence interval of the hierarchical primary endpoint event rate in ROADSTER (3.5%) was statistically significantly less than the objective performance criterion (11%; P = .0047). Notably, the any stroke rate of 1.4% (0.7%, PP) in a high surgical risk population is the lowest to date for CAS and comparable to the periprocedural standard surgical risk CEA arm of CREST (2.3%). The ENROUTE transcarotid NPS appears to be safe and effective for obtaining direct carotid access and preventing embolic events during CAS.

Read More: http://www.prnewswire.com/news-releases/late-breaking-clinical-trial-results-announced-at-viva-14-281541771.html

REDWOOD CITY, Calif., Nov. 3, 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, has been granted a new patent (U.S. Patent No. 8,858,941) in the United States for OncoMed's anti-DLL4/anti-VEGF bispecific antibody (OMP-305B83) and use of the bispecific antibody in the treatment of cancer. The new patent includes both composition-of-matter and method of treatment claims for the antibody. Related patent applications are pending in the United States, Europe, Japan, China and a number of other countries worldwide.

OncoMed's anti-DLL4/ant-VEGF bispecific antibody is one of many exciting programs in our preclinical development portfolio," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer. "The activity of anti-DLL4, with its robust anti-cancer stem cell and dysangiogenic properties, is expected to complement the anti-angiogenic activity of anti-VEGF to create a potent anti-tumor combination. We plan to initiate clinical trials of our novel bispecific antibody as early as late 2014 or early 2015."

OncoMed recently filed an Investigational New Drug (IND) application for its anti-DLL4/anti-VEGF bispecific antibody (OMP-305B83), a novel humanized antibody generated using OncoMed's proprietary antibody technology platform. Preclinical studies suggest that the bispecific antibody may exhibit multiple mechanisms of action: (1) by targeting DLL4 and downregulating Notch pathway signaling, the antibody is expected to have an anti-CSC effect; and (2) by targeting DLL4 and VEGF, two central regulators of tumor angiogenesis, the antibody is expected to disrupt and inhibit tumor angiogenesis. In preclinical studies, the combined inhibition of DLL4 and VEGF has resulted in significant anti-tumor activity in a variety of patient-derived xenograft models.  OncoMed's anti-DLL4/anti-VEGF bispecific antibody is part of OncoMed's collaboration with Celgene Corporation.

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Phase I Data on Anti-Notch1 Selected for Oral Plenary Presentation

REDWOOD CITY, Calif., Oct. 30, 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, will present clinical data from three anti-cancer stem cell clinical programs at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Meeting to be held November 18-21, 2014 in Barcelona, Spain.

Among the presentations will be clinical data from OncoMed's anti-Notch1 (OMP-52M51) solid tumor clinical trial. Interim results from the Phase 1a study have been selected for an oral plenary session presentation. Additional data will be presented from the demcizumab (anti-DLL4, OMP-21M18) and tarextumab (anti-Notch2/3, OMP-59R5) programs.


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Wright Medical Group Inc. (WMGI:US), a U.S. maker of bone implants, will merge with Tornier NV, creating a new company valued at $3.3 billion in the latest proposed tax inversion since tighter rules were announced last month.

The legal address for the new company, to be called Wright Medical Group NV, will be in the Netherlands, where Tornier has been based for about eight years, the companies said yesterday in a statement. Wright has been based in Memphis, Tennessee, where the new combined company’s U.S. headquarters will remain, according to the statement.

“This combination will create the premier extremities-biologics company with a broad global reach,” Robert Palmisano, Wright’s president and chief executive officer, said in the statement. “Together, we will have one of the most comprehensive upper and lower extremity product portfolios in the market.”

Read More: http://www.businessweek.com/news/2014-10-27/wright-medical-will-merge-with-tornier-in-all-stock-deal

MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced the U.S. Food and Drug Administration (FDA) approval of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm. This approval follows a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The Lutonix® 035 DCB—the first and only FDA-approved DCB in the U.S.— is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.

“The Lutonix® 035 DCB gives clinicians another option as they seek to provide prolonged patency to patients confronted with femoropopliteal occlusive disease.”

FDA approval of the Lutonix® 035 DCB was supported by results of the LEVANT 2 pivotal study, a global, prospective, single-blind, randomized, 54-site study (42 sites in the U.S. and 12 in Europe) that enrolled all patients under one protocol. At one year, the LEVANT 2 study demonstrated improved patency of the Lutonix® 035 DCB compared to standard PTA: 73.5 percent vs. 56.8 percent, p<0.001 by Kaplan-Meier time-to-event analysis. It also demonstrated clinical benefits of sustained improvement in Rutherford Class and improved walking distance scores. The LEVANT 2 study followed a rigorous blinding protocol designed to reduce bias in the results to accurately and scientifically assess and compare the long-term performance of key clinical measures. The LEVANT clinical program, which includes registry data, enrolled more than 1,000 patients and demonstrated robust safety of the device comparable to PTA, including the same low rate of distal embolic events and rate of reintervention for thrombotic events.

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 OncoMed (OMED) presented updated results from two phase 1b trials of
demcizumab (anti-DLL4) at the ESMO 2014 Congress over the weekend. Both
studies demonstrated encouraging tumor response rates. In the pancreatic cancer
study, demcizumab + gemcitabine + ABRAXANE demonstrated a 41% partial 
response (PR) rate and a 45% stable disease (SD) rate, resulting in an overall
clinical benefit rate of 86%. In the non-squamous NSCLC study, demcizumab +
ALIMTA + carboplatin demonstrated 3% CR, 45% PR, and 39% SD, resulting
in an overall clinical benefit rate of 88%. Demcizumab was described as
generally well tolerated in both studies. The truncated dosing schedule for
demcizumab appeared to prevent the onset of late cardiopulmonary toxicity, as
none of the 64 patients in the two studies who received the truncated dosing 
experienced any moderate-to-severe cardiopulmonary toxicities. Phase 2 studies
in these two cancer indications are expected to commence by the end of 2014. 

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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."

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