Baxter Initiates Phase I Clinical Trial With Anti-MIF Antibody; Tragacept Announces Plans to Develop TC-5214 Print E-mail
By Staff and Wire Reports   
Wednesday, 05 September 2012 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 5, 2012.

Baxter International Inc. (NYSE: BAX )
announced the company has begun dosing patients with malignant solid tumors in a Phase I clinical trial of a monoclonal antibody, representing the company's efforts to extend its oncology portfolio with advanced biological research and development.

The candidate is a fully-human, recombinant anti-MIF (anti-macrophage migration inhibitory factor) monoclonal antibody with potential to be a new therapeutic agent in treatment of cancer. Monoclonal antibodies target a specific antigen in the body rather than traditional, systemic regimens. The anti-MIF antibody targets the MIF protein, a protein that induces inflammatory responses in the body and that has also been shown to influence the growth and spread of tumors. By inhibiting the cancer-promoting effects of MIF, the anti-MIF antibody may be capable of restricting the growth of tumors.


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Targacept (NASDAQ: TRGT)
, a clinical-stage biopharmaceutical company developing novel NNR Therapeutics ™, announced it plans to pursue development of TC-5214 as a treatment for overactive bladder (OAB). Based on TC-5214's unique pharmacokinetic profile, an analysis of data from a completed clinical program and findings from additional preclinical studies, the company plans to initiate a Phase 2b study of TC-5214 in the first half of 2013.

“Current treatments for OAB have efficacy and tolerability shortcomings that limit their utility for many patients. The extensive renal excretion of TC-5214 suggests that a low dose of the drug should produce high bladder concentrations that could diminish sensations of urgency and be well tolerated,” said Michael Chancellor, M.D., Professor, Oakland University, William Beaumont School of Medicine and Chairman of the Urology Department at Beaumont Hospital. “Development of an oral drug with targeted effects at nicotinic receptors located in the bladder would represent a welcomed advance towards a potential new treatment paradigm for patients with OAB.”



Also Wednesday:



ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced the completion of enrollment in its ongoing pivotal Phase III trial with pimavanserin in patients with Parkinson’s disease psychosis (PDP).

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN)
today announced that Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the Morgan Stanley Global Healthcare Conference in New York City at 9:45 a.m. Eastern time on Wednesday, September 12, 2012.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today complete results from its Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients.

Alimera Sciences, Inc., (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has accepted for consideration additional data in the form of an appendix to Alimera's comments on the preliminary Appraisal Consultation Document (ACD) previously issued by NICE for the ILUVIEN®Single Technology Appraisal (STA).

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

Array BioPharma Inc. (NASDAQ: ARRY)
announced that Francis Bullock, Ph.D., and Kevin Koch, Ph.D., have decided not to stand for reelection to its Board of Directors and that David Snitman, Ph.D., intends to resign from the Board of Directors.

Baxter International Inc. (NYSE: BAX)
previously announced that it will host its 2012 Investor Conference on Tuesday, October 9, 2012 at the Ritz-Carlton Hotel in Chicago, IL, from 8:00 a.m. until approximately 3:30 p.m. CT.

Bristol-Myers Squibb Company (NYSE: BMY)
will take part in the Morgan Stanley Global Health Care Conference on Monday, September 10, 2012, in New York.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
today announced that it is seeking nominations for its Science Education Leadership Award program, which honors innovative science teachers in middle and high schools throughout New England.

Cytomedix, Inc. (OTCQB: CMXI)
, a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, today announced that the Company's AutoloGel™ System will be highlighted in an oral abstract and a poster presentation at the 4th Congress of the World Union of Wound Healing Societies (WUWHS 2012) being held from September 2-6, in Yokohama, Japan.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care focused company using blood purification to modulate the immune system, reduce severe inflammation, and mitigate organ failure caused by life-threatening illnesses, announced that Dr. Phillip Chan, Chief Executive Officer, will present at the 14th Annual Healthcare Conference at the Rodman & Renshaw Global Investment Conference.

Dyadic International, Inc. (OTC Pink: DYAI)
, a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins for the industrial enzyme, bioenergy, bio-based chemical and biopharmaceutical industries, announced today that its research and development center in the Netherlands is a participant in the HealthBread Project, a new multidisciplinary research program that has been awarded approximately one million Euro from the European Community's Seventh Framework Programme (FP7).

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
announced today that it has amended the Company’s Loan and Security Agreement with MidCap Financial, LLC ("MidCap" or the “Lender”) effective August 27, 2012.

Galectin Therapeutics (NASDAQ: GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that as of October 1, 2012, its corporate offices will be moved to Atlanta, Georgia, while maintaining a laboratory-based effort in the Boston area.

GenSpera, Inc. (OTCBB:GNSZ)
announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has cleared for initiation a Phase II human clinical trial of its lead compound, G-202, in the treatment of prostate cancer patients who have failed prior hormonal therapy.

Gilead Sciences, Inc. (Nasdaq: GILD)
today announced that its corporate presentation will be webcast from Baird’s 2012 Healthcare Conference in New York.

Idera Pharmaceuticals, (NASDAQ: IDRA)
a biotechnology company developing Toll-like receptor candidates for the treatment of autoimmune diseases and for use as vaccine adjuvants, today announced that members of the management team will be presenting at the Rodman & Renshaw Annual Global Investment Conference taking place at the Waldorf Astoria in New York City.

Immunotech Laboratories, Inc. (PINKSHEETS: IMMB)
signed a contract with strategic partners in Bulgaria to register a company called Immunotech Laboratories B.G. LLC. Immunotech Laboratories, Inc. will own 34% of the Bulgarian subsidiary.

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI)
will be presenting at the following upcoming conferences:  Rodman & Renshaw Annual Global Investment Conference – New York City, September 10, 2012, at 4:55 p.m. ET.

InSite Vision Incorporated (OTCBB: INSV)
today introduced DuraSite 2®, its next-generation enhanced drug delivery system which provides a broad platform for developing superior ophthalmic therapeutics.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that it expects to submit its Biologic License Application (BLA) for Natpara™ (recombinant human parathyroid hormone (rhPTH [1-84])) in mid-2013.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
will present at the Stifel Nicolaus Annual Healthcare Conference in Boston on Thursday, September 6, 2012 at 8:35 a.m. ET.

OncoSec Medical Inc. (OTCBB: ONCS)
, a company developing its advanced-stage ImmunoPulse and NeoPulse technologies to treat solid tumor cancers, received a new Method of Use and Device patent (Patent Application No. 200780014313.0, "Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection") for the OncoSec Medical System (OMS) electroporation device platform from the State Intellectual Property Office of the People's Republic of China.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
today announced an update to the projected timeframe for enrollment of patients in the Light Study, the cardiovascular outcomes clinical trial evaluating Contrave® (naltrexone SR/ bupropion SR).

Pharmacyclics, Inc. (Nasdaq: PCYC)
today reported financial results and recent developments for its fiscal year and fourth quarter ended June 30, 2012.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN)
, a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in oncology and CNS, today provided an update on its strategic business goals for 2012.

Safeguard Scientifics, Inc. (NYSE: SFE)
, a holding company that builds value in growth-stage life sciences and technology companies, today announced that it will be hosting Investor Day 2012 at The Yale Club of New York City on Tuesday, October 9, 2012.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP)
today announced that five presentations describing the investigation of methylnaltrexone bromide as a potential treatment for opioid-induced constipation in adult patients with chronic, non-cancer pain will occur during The National Conference on Pain for Frontline Practitioners, or “PAINWeek”.

Shire plc (LSE: SHP, NASDAQ: SHPG)
, today announced that its lead regenerative medicine product, DERMAGRAFT (human fibroblast-derived dermal substitute) has received regulatory approval from Health Canada as a class IV medical device for the treatment of diabetic foot ulcers (DFUs), a complication of diabetes.

Sigma-Aldrich® Corporation (NASDAQ: SIAL)
today announced that its recent acquisition, BioReliance, the biopharma and early development services business under SAFC, will introduce a new assay to detect DNA damage from products with dermal routes of exposure.

SpectraScience, Inc. (OTCQB: SCIE) (PINKSHEETS: SCIE)
, a San Diego-based medical device company, today announced it has successfully completed installation and training for the WavSTAT4 Optical Biopsy System with PENTAX Europe at multiple customer sites, including the United Kingdom (London), France (Paris and Nantes), The Netherlands (Maastricht and Breda), and Germany (Erlangen).

WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology and medical device R&D outsourcing company with operations in China and the United States, and Open Monoclonal Technology, Inc. (OMT), an innovator in novel transgenic animals for development of human therapeutic antibodies, today announced that they have entered into an agreement to use OMT’s OmniRat™ to develop therapeutic antibody candidates for commercialization by WuXi’s global customers.

Zalicus Inc. (NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that it has initiated the first of two Phase 2a clinical studies with Z160, its first-in-class, oral, state-dependent, selective N-type calcium channel blocker for the treatment of chronic neuropathic pain indications.



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