|OXiGENE Closes Enrollment of ZYBRESTAT; Cerus Announces FDA Agreement for INTERCEPT Platelets|
|By Staff and Wire Reports|
|Wednesday, 24 April 2013 19:44|
OXiGENE, Inc. (Nasdaq: OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that enrollment has been completed in a randomized Phase 2 clinical trial testing the combination of ZYBRESTAT® (fosbretabulin; CA-4P) plus bevacizumab to treat patients with advanced ovarian cancer. This trial, GOG-0186I, is being conducted by the Gynecologic Oncology Group (GOG) under the sponsorship of Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
This is the first and currently the only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent in ovarian cancer, without including any cytotoxic chemotherapy. The fosbretabulin tromethamine is being provided to CTEP under a Cooperative Research and Development Agreement (CRADA) with OXiGENE and the bevacizumab is being provided under a CRADA with Genentech, Inc.
Cerus Corporation (NASDAQ: CERS) announced the U.S. FDA has accepted its proposed modular Premarket Approval (PMA) application shell for review of the INTERCEPT Blood System for platelets. A PMA shell is an outline of the application process that defines the structure, content and timing of each module. FDA and the applicant need to agree on a shell prior to initiation of a modular PMA submission.
A modular PMA review process is based on submission of a compilation of sections or "modules" at 90-day intervals that together become a complete PMA application. Under a modular approach, FDA is able to review each module separately, allowing the applicant to receive timely feedback and potentially resolve deficiencies earlier in the review process than would be expected with a traditional PMA application. Cerus currently has a PMA application with respect to its plasma system that is being submitted in four modules. The PMA application shell accepted by the FDA for the platelet system provides for three modular submissions, with the first module scheduled for submission at the end of September.
3SBio Inc. (NASDAQ: SSRX), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has entered into an amendment (the "Amendment") to its previously announced agreement and plan of merger dated as of February 8, 2013, by and among Decade Sunshine Limited ("Parent"), Decade Sunshine Merger Sub ("Merger Sub") and the Company (the "Merger Agreement", and the Merger Agreement as so amended, the "Amended Merger Agreement"), pursuant to which Merger Sub will be merged with and into the Company, with the Company surviving the merger as a wholly-owned subsidiary of Parent (the "Merger").
In newly published news, CEL-SCI Corporation (NYSE MKT: CVM) has provided investors a much needed update on the Phase III Clinical Trial of its investigational drug Multikine.
CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for orthopedic and general surgery, announced today that the Company will participate in the 12th Annual Needham Healthcare Conference on Tuesday, April 30, 2013 at 2:20 PM Eastern Time.
Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, today announced an important milestone, commemorating five years of providing biosimilars to the European market and delivery of more than five million doses of high-quality biosimilar medicines at a lower cost to patients in Europe and Australia.
Ingen Technologies, Inc. (PINKSHEETS: IGNT) is pleased to announce that the final revisions of the cash and purchase price of the Purchase and Agreement of Acquisition have been accepted by both parties and is anticipated to close this week. Details were not disclosed.
LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME) ("LED Medical"), a strategic partner in Second Step Laboratory Services with PMI is pleased to announce the results of an independent study published in "Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology" (Vol. 114 No. 3) that confirms the use of quantitative cytology ("QC") testing, as an adjunctive tool, successfully identifying high-risk potentially malignant disorders of the oral mucosa.
MMRGlobal, Inc. (OTCQB: MMRF) today announced that Unisoft Group/Unis-Tonghe Technology (Zhengzhou) Co., Ltd. (Unis) Vice President and Chairman Luo Jianhui is scheduled to arrive in Los Angeles this Sunday for meetings with MMRGlobal CEO Robert H. Lorsch.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has priced an underwritten sale of common stock in a transaction involving J.P. Morgan Asset Management and one other institutional investor.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences, will be presenting at the Needham 12th Annual Healthcare Conference in New York City.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is pleased to announce the official opening of its Tokyo, Japan office, which will strengthen the Company's ability to bring game-changing products, procedures, and services to the second largest spine market in the world.
Omeros Corporation (NASDAQ: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today announced that it will present at the 12th Annual Needham Healthcare Conference next week.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced it has been named a recipient of the 2013 "Partnership Pioneers of the Year" award in recognition of its innovative strategic partnership with Pfizer and ICON.
Plandai Biotechnology, Inc. (OTCQB: PLPL), a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced arrival of the first shipment of factory equipment to its production facility in South Africa.
Senomyx, Inc. (NASDAQ: SNMX), a company using proprietary taste science technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that Kent Snyder, the Company's Chief Executive Officer, and John Poyhonen, President and Chief Operating Officer, will present an overview of the Company's technology and programs on Wednesday, May 1, at 10:00 a.m. Eastern Time (7:00 a.m. Pacific Time) during the 12th Annual Needham Healthcare Conference.