Novavax Offers Top-Line Results from Phase 2 Trial of RSV Vaccine Candidate; Medtronic Receives FDA Clearance Print E-mail
By Staff and Wire Reports   
Tuesday, 02 April 2013 19:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2013.

Novavax, Inc. (Nasdaq: NVAX) announced top-line data from the Phase II dose-ranging clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age accomplished the trial's protocol-specified objectives and supports progression to the next stage of advanced clinical testing. The trial represents an important step towards establishing the safety and immunogenicity of the vaccine candidate for use in a maternal immunization strategy. In such a strategy, the antibodies in vaccinated women can be expected to be naturally transferred to their infants in utero and thereby may confer passive protection at the earliest stage of life when these infants are extremely vulnerable to severe respiratory disease due to RSV.

This randomized, blinded, placebo-controlled Phase II clinical trial evaluated the safety and immunogenicity of two-dose levels of Novavax' RSV F protein nanoparticle vaccine candidate with and without aluminum phosphate (alum) as an adjuvant. The study enrolled 330 women of childbearing age who received either one or two intramuscular injections of a single-dose of vaccine or placebo, at study day 0 and day 28. Doses of 60 and 90 µg were tested, either with or without alum as an adjuvant. Safety and immunogenicity data for this clinical trial have been evaluated through day 56. Safety will continue to be evaluated over a total period of six months and immunogenicity for four months for each participant. The clinical trial is being conducted in collaboration with PATH, an international nonprofit organization that transforms global health through innovation. PATH committed funding of approximately $2 million to support this trial with the aim of advancing the development of an RSV vaccine to protect infants through maternal immunization in low-resource countries.

In this trial, the vaccine candidate was generally well-tolerated and the safety profile was similar to that observed previously in the Phase I clinical trial. The principal observation was transient mild to moderate injection site pain, predictably somewhat more frequent in the adjuvanted vaccine recipients. There were no clinically important differences in systemic adverse events between placebo and active vaccine recipients and no vaccine related SAEs. The most commonly reported systemic reactogenicity was comprised mainly of mild to moderate headache, fatigue and muscle ache, which are frequently noted after treatment by many vaccines. There were no differences in safety assessments across doses (60 and 90 µg) or worsening of reactogenicity with a second-dose. Laboratory testing did not reveal clinically significant changes in normal blood chemistries or hematology parameters.

The primary objectives of the study measured the difference in anti-F IgG elicited by the use of alum adjuvant, one versus two immunizations, and across doses (60 and 90 µg). The use of alum enhanced both the single and two-dose regimen anti-F IgG responses, with the greatest responses observed using a two-dose regimen. Peak geometric mean titers of anti-F IgG in the two-dose alum groups ranged from 12,000-14,000 representing a 13 to 16-fold rise, compared to a 6 to 10-fold rise in the non-alum groups. Minimal increases were observed by increasing the doses (60 to 90 µg). Peak geometric mean RSV A neutralizing antibodies in the alum groups ranged from log[2] 9.5-10.5, representing a 3.1 to 3.8-fold rise. Palivizumab-like antibody titers rose 8 to 9-fold, with four-fold rises in ≥92% of vaccinees in the two-dose alum adjuvanted vaccine groups. Overall, the immune responses observed in this Phase II clinical trial were similar to, or exceeded immune responses seen in the Phase I clinical trial using the Novavax nanoparticle vaccine.



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Medtronic, Inc. (NYSE: MDT)
announced U.S. FDA 510(k) clearance and the first U.S. clinical uses of its new Affinity Fusion® oxygenation system. This system, which is designed to serve as a patient's lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for patient safety and ease of use. Notably, system enhancements are designed to prevent and remove air bubbles that can enter the blood during the procedure, which may potentially reduce the risk of stroke.

The Affinity Fusion oxygenation system's new design enhancements include:

A proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood; o Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which can reduce blood turbulence during the surgical procedure;

Enhanced setup and customization capabilities, including a new oxygenator system holder, which gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.



Also Tuesday:




Amarantus BioScience, Inc. (OTCQB: AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, has appointed Adam J. Simon, Ph.D., to its Board of Advisors.

Frazier Healthcare is pleased to announce that it has signed a definitive agreement to acquire AndersonBrecon, the contract pharmaceutical packaging business and wholly owned subsidiary of AmerisourceBergen Corporation (NYSE: ABC)

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)
today announced FDA acceptance of its IND and the treatment of the first fifteen (15) patients in its clinical trial using Ampion™ to treat osteoarthritis (OA) of the knee.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today announced that it had made a donation to the Chronic Disease Fund (CDF) in support of patients with chronic myeloid leukemia (CML) who are resistant or intolerant to prior therapy.

Baxter International Inc. (NYSE: BAX)
is incorporating innovative technologies and has recently established new partnerships in its commitment to environmental sustainability and increasing access to healthcare.

CEL-SCI Corporation (NYSE MKT: CVM)
announced today that it has released a new video about its investigational cancer drug Multikine* and the dedicated manufacturing facility to produce Multikine near Baltimore, MD, USA.

Centene Corporation (NYSE: CNC)
announced today that on April 1, 2013, it completed the purchase of Specialty Therapeutic Care Holdings, Inc. (d/b/a AcariaHealth), one of the nation's largest, independent, comprehensive specialty pharmacy companies, from Enhanced Equity Funds.

China Cord Blood Corporation (NYSE: CO)
("CCBC" or the "Company"), the first and largest cord blood banking operator in China, today announced that the cord blood bank operated by its Beijing subsidiary has been granted the AABB Accreditation, as a certification of its quality excellence of providing cord blood processing and storage services.

Compugen Ltd. (NASDAQ: CGEN)
disclosed today the initiation of its second focused discovery program, aimed at identification of novel targets for antibody-drug conjugate (ADC) cancer therapy focusing on clinical situations with poor survival rates and/or recurrent cancers.

Diagnostic Imaging International Corp. (OTCQB:DIIG)
announced today that it has filed its 2012 10-K report and provided an update on its financial results for 2012.

Full Research Reports on the Following Micro-Cap Stocks: DMHI International Inc. (OTCQB: DHMI), Kalahari Greentech Inc. (PINKSHEETS: KHGT), Bebida Beverage Company (PINKSHEETS: BBDA) and Medifirst Solutions Inc. (OTCQB: MFST).

Entia Biosciences (OTCQB: ERGO)
, a food science biotechnology company and emerging leader in the field of Nutrigenomics, has now received three Patent Notices of Allowance covering the use of Ergothioneine and its genetic transporter in the treatment of a wide variety of diseases, including those affecting the immune and central nervous systems.

Ingen Technologies, Inc.'s (PINKSHEETS: IGNT)
is pleased to announce that on April 1, 2013, Ingen and ATMC Inc. have executed the "Letter of Intent" to merge the two companies. Ingen has moved forward to acquire ATMC Inc.

InSite Vision Incorporated (OTCBB: INSV)
today announced that it agreed to sell its royalty on future sales of Besivance®, to SWK Funding LLC, a wholly-owned subsidiary of SWK Holdings Corporation (OTCBB: SWKH) and Bess Royalty, L.P. for up to $16 million. Besivance (besifloxacin ophthalmic suspension) 0.6% is marketed globally by Bausch + Lomb for the treatment of bacterial conjunctivitis.

Life Technologies Corporation (NASDAQ: LIFE)
today announced it launched two Ion AmpliSeq™ Community Panels: the Ion AmpliSeq™ BRCA1 and BRCA2 Panel design and the Ion AmpliSeq™ Colon and Lung Cancer Panel design.

MMRGlobal, Inc. (OTCQB: MMRF)
, a leading provider of Personal Health Records ("PHRs"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that it filed its Annual Report on Form 10-K for the period ended December 31, 2012 with the U.S. Securities and Exchange Commission on April 1, 2013.

NewLink Genetics Corporation (NASDAQ: NLNK)
, a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the initiation of a double-blind, randomized, placebo-controlled Phase 2 clinical study of its first IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, indoximod, in patients with metastatic breast cancer.

Omeros Corporation (NASDAQ: OMER)
today announced positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 (MASP-2) program, in a well-established animal model of thrombotic microangiopathy (TMA), a disorder that occurs in the microcirculation (e.g., venules and capillaries) of the body's organs, most commonly the kidney and brain.

PAREXEL International Corporation (NASDAQ: PRXL)
will release financial results for the Third Quarter of Fiscal Year 2013 on Tuesday, April 30, 2013 after the close of the stock market.  The announcement will be available on PAREXEL's website at www.PAREXEL.com and on the PR Newswire website at www.prnewswire.com.

Pathfinder Cell Therapy, Inc. (OTCQB: PFND)
, a biotechnology company focused on the treatment of diseases characterized by organ-specific cell damage, today announced publication of groundbreaking preclinical data demonstrating that the Company's unique cell-based therapy is able to regenerate and enable functional repair of damaged tissue even when extracted from a different species and tissue type.

Quture International, Inc. (OTCQB: QUTR)
announced today that real-time clinical data was recently collected for approximately 800 perioperative patients at the University of Miami/Jackson Memorial Hospital (UoM).

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN)
, a clinical stage biopharmaceutical company developing potential best-in-class oncology therapies, today announced that it will present mechanism of action data on RX-5902 during a poster session at the American Association for Cancer Research (AACR) 104th Annual Meeting being held in Washington, DC, April 6-10, 2013, at the Washington Convention Center.

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, announces that two posters related to the Company's microRNA-based diagnostic assays will be featured at the American Association for Cancer Research (AACR) Annual Meeting 2013, to be held April 6-10 at the Walter E. Washington Convention Center in Washington, D.C.

Zalicus Inc. (Nasdaq Global Market: ZLCS)
, a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain, today announced that it has been granted a patent by the U.S. Patent and Trademark office (USPTO) covering novel formulations of its product candidate Z160.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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