Baxter Initiates Phase I Clinical Trial of Treatment for Hemophilia A; Chelsea Announces Proposed Public Offering of Common Stock Print E-mail
By Staff and Wire Reports   
Thursday, 05 January 2012 20:26

Below is a look at some of the headlines for companies that made news in the healthcare sector on January 5, 2012.

Baxter International Inc. (NYSE:BAX) announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein. BAX 855 is based on Baxters ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] full-length rFVIII molecule and plasma/albumin-free (PAF) manufacturing process.

The Phase I trial is a prospective, open-label study that will assess the safety, tolerability and pharmacokinetics of BAX 855 in previously-treated patients aged 12 years or older with severe hemophilia A. When used for prophylaxis, Baxters ADVATE requires patients to infuse every two to three days to reduce the occurrence of bleeding episodes. This Phase I trial is the first step in assessing whether BAX 855 can be infused less frequently.

This trial is designed to provide new insights about our investigational longer-acting FVIII molecule, BAX 855, with the ultimate goal of improving care for patients living with hemophilia A, said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxters BioScience business. The Phase I results will serve as the foundation for advancing this important program through clinical development and determining whether BAX 855 can offer a treatment regimen requiring fewer infusions than ADVATE.

BAX 855 employs Baxters proprietary full-length plasma/albumin-free recombinant protein platform that does not contain any human or animal-derived additives. BAX 855 leverages Nektar Therapeutics (NKTR) proprietary PEGylation technology, which is designed to extend the duration of activity of proteins and larger molecules. Baxter and Nektar have a collaboration to develop PEGylated products designed to provide new long-acting therapies for hemophilia patients.

ADVATE was recently approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. With the inclusion of prophylaxis in the adult patient population, ADVATE became the only antihemophilic factor approved in the United States for prophylactic use in both children and adults. This approval was supported by a Phase IV prophylaxis study sponsored by Baxter demonstrating that ADVATE for routine prophylaxis significantly reduced median annual bleed rates (ABR) in hemophilia A patients.


Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP) announced its intention to offer, subject to market and other conditions, $20.0 million of its common stock in an underwritten public offering pursuant to its existing shelf registration statement. The company also intends to grant to the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock sold in the public offering to cover over-allotments, if any.

Leerink Swann LLC is acting as the sole book-running manager for the offering. Needham & Company, LLC and Roth Capital Partners, LLC are acting as the co-managers of the offering.

The securities described above are being offered by Chelsea pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering. The offering may be made only by means of a prospectus, copies of which may be obtained, when available, from Leerink Swann LLC, Attention: Syndicate Prospectus Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, by telephone at 617-918-4814, or by facsimile at 617-918-4914.

Also Thursday:

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that it entered into a collaboration agreement with Ventana Medical Systems, Inc., a member of the Roche Group, to develop a companion diagnostic for the immunohistochemical determination of luteinizing hormone-releasing hormone (LHRH) receptor expression, for the Company's doxorubicin LHRH targeted conjugate compound, AEZS-108.

AtheroNova, (OTCQB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, announced today that it has appointed Johan M. (Thijs) Spoor as a new member to the Board of Directors of the Company effective January 3, 2012.

Baxter International Inc. (NYSE: BAX) today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in two investor conferences during the second week of January 2012

Deaf-Talk, Inc., dba DT Interpreting (PINKSHEETS: MGQG) (DTI), the industry leader in on-demand video sign language interpreting, announced today that it has instituted DT Video Hub, an internet-based service that not only integrates with existing dedicated video conferencing equipment but also with Internet-connected tablets, PC notebooks, MACs, iPhones, iPad2s and Android mobile phones.

Dendreon Corporation (Nasdaq: DNDN) today announced revenue for the fourth quarter ended December 31, 2011, reporting gross product revenue of approximately $82 million.

Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that President and CEO Bruce Barclay is scheduled to present at the 30th Annual J.P. Morgan Healthcare Conference.

InterMune, Inc. (NASDAQ: ITMN)
today announced unaudited net sales of Esbriet® (pirfenidone) for the fourth quarter ended December 31, 2011, as well as information on the number of patients that initiated Esbriet therapy in Germany during 2011.

INSYS Therapeutics (PINKSHEETS: NEOL) announces the US Food and Drug Administration approval of its branded breakthrough cancer pain medication, SUBSYS® fentanyl sublingual spray.

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (PINKSHEETS: KBLB) is very happy to start the New Year by announcing that the Journal Proceedings of the National Academy of Sciencespublished a peer-reviewed scientific article describing the breakthrough creation of a spider silk fusion fiber, which was achieved by university scientists within the University of Wyoming and the University of Notre Dame, who are working cooperatively with Kraig Biocraft Laboratories.

Life Technologies Corporation (NASDAQ: LIFE) has received validation from the certification body of Association Francaise de Normalisation (AFNOR) for its MicroSEQ® Listeria spp. and MicroSEQ® Listeria monocytogenes assays, molecular tests that are designed to quickly and accurately detect the presence or absence of this food-borne pathogen that most recently has been associated with an outbreak in cantaloupes.

Ohr Pharmaceutical Inc. (OTCBB: OHRP) announced today that Dr. Irach B. Taraporewala, President and Chief Executive Officer, will present a corporate overview at the Biotech Showcase™ 2012 in San Francisco, CA on Monday, January 9, 2012 at 4:30 p.m. PT (7:30 p.m. ET).

Rainbow Coral Corp. (OTCBB: RBCC) has ambitious plans for 2012. Not only is the company working diligently to complete its acquisition of Nano3D Biosciences (n3D), but developing a business plan to market the breakthrough Bio-Assembler system to cell researchers around the world, as well.

Targacept, Inc. (NASDAQ:TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced that AstraZeneca has informed the company that it plans to progress the development of Targacept’s product candidate AZD1446 as a treatment for Alzheimer’s disease.

WaferGen Biosystems, Inc. (OTCBB:WGBS), an emerging genomic analysis company, today announced that the company plans to deliver its corporate presentation at the 5th Annual OneMedForum San Francisco 2012, at the Sir Francis Drake Hotel, San Francisco, Calif., January 9-12, 2012.


"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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