Amicus Presents Preclinical Studies for Gaucher Disease; AVI BioPharma Results From Phase I Clinical Trial Print E-mail
By Staff and Wire Reports   
Thursday, 09 February 2012 20:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 9, 2012.

Amicus Therapeutics (Nasdaq: FOLD)
presented preclinical studies of AT3375 as a monotherapy and in combination with enzyme replacement therapy for Gaucher disease during the 8th Annual Lysosomal Disease Network WORLD Symposium (LDN WORLD).

AT3375 is a next-generation, small molecule pharmacological chaperone that targets the glucocerebrosidase (GCase) enzyme deficient in Gaucher disease, a mechanism with the potential to address Gaucher and Parkinson's. AT3375 was the lead compound selected from a series of chaperones designed by Amicus to improve upon the properties of AT2101 (isofagomine tartrate), a first-generation chaperone that Amicus was originally developing for Gaucher disease.

The oral presentation at LDN WORLD was titled, "Preclinical Results Exploring the Use of Pharmacological Chaperone AT3375 Alone and in Combination with Recombinant Human Beta-Glucosidase for Gaucher Disease." Key highlights were as follows:

In combination with ERT, AT3375 binds to and stabilizes the recombinant enzyme, minimizing its thermal denaturation and loss of activity in vitro. AT3375 co-administered with ERT increased active enzyme in plasma and Gaucher-disease relevant tissues (liver, spleen and lung) compared to AT2101 co-administered with ERT. In addition, ERT co-administered with either chaperone increased enzyme activity compared to ERT alone. When used as a monotherapy, AT3375 increased GCase activity in patient-derived cells with greater potency compared to AT2101. In mouse models, higher levels of AT3375, orally administered as a monotherapy, were present in the brain and the compound was cleared more rapidly than AT2101. AT3375 increased brain GCase levels with greater potency compared to AT2101.


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AVI BioPharma, Inc. (NASDAQ: AVII)
announced positive safety results from all six dose cohorts in the single ascending dose studies of AVI-6002 and AVI-6003, AVI's lead drug candidates being evaluated for the treatment of Ebola virus and Marburg virus, respectively. AVI is conducting this work under a Department of Defense contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office.

Data from 60 subjects in 12 cohorts from the AVI-6002 and AVI-6003 studies combined were evaluated by an independent Data and Safety Monitoring Board (DSMB), which issued recommendations for both studies to progress as planned to multiple ascending dose studies after no safety concerns were identified. The Phase I single ascending dose trials were designed to characterize the safety, tolerability and pharmacokinetics of each therapeutic candidate in healthy adult volunteers.



Also Thursday:



Acetylon Pharmaceuticals today announced that Celgene Corporation (NASDAQ: CELG) will invest a total of $15 million in Acetylon via the purchase of Series B-2 Preferred Stock.

Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that it will host a conference call and live webcast to report its fourth quarter and full year 2011 financial results on Thursday, February 16 at 8:30 a.m. ET.

Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that Tom Moore, Chairman & CEO of Advaxis, will present a corporate overview of the Company at the 14th Annual BIO CEO & Investor Conference at the Waldorf=Astoria in New York City on February 13, 2012 at 10:30am EST in the Duke of Windsor room.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today that its scientists have discovered a novel method for monitoring RNAi activity in blood samples, representing a potential major advance for future development of RNAi therapeutics, other therapeutic modalities, and diagnostics.

Array BioPharma Inc. (Nasdaq: ARRY)
today announced that its President and Chief Scientific Officer, Kevin Koch, will speak at the Leerink Swann Healthcare Conference in New York.

ArQule, Inc. (Nasdaq: ARQL)
today announced that the Company will present at the Leerink Swann 2012 Global Healthcare Conference on February 16, 2012 at 11:00 a.m.

Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that Ron Cohen, M.D., President & CEO, will present at the Leerink Swann 2012 Global Healthcare Conference on Thursday, February 16, 2012 at 4:00 pm ET at the Walfdorf=Astoria Hotel in New York, NY.

BioClinica®, Inc. (NASDAQ: BIOC)
, a global provider of clinical trial management solutions, today announced its financial results for the fourth quarter and year ended December 31, 2011.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
, announced today that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects.

Celldex Therapeutics, Inc. (NASDAQ: CLDX)
today announced that Thomas Davis, M.D., Senior Vice President and Chief Medical Officer of Celldex Therapeutics, Inc., will participate with other industry executives in a therapeutic workshop panel discussion titled Drugs Need Friends Too – Companion Diagnostics and Drug Development.

Covidien (NYSE: COV), a leading global provider of healthcare products, will present at the Leerink Swann 2012 Global Healthcare Conference in New York, New York, on February 16, 2012.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST)
today announced that it has received a Paragraph IV Notice Letter from Hospira, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of CUBICIN® (daptomycin for injection).

Cyanotech Corporation (Nasdaq Capital Market: CYAN), a world leader in microalgae-based, high-value nutrition and health products, today announced financial results for the third quarter and first nine months of fiscal year 2012, ended December 31, 2011.

EasyMed Services, Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6)
, a leading provider of mobile technology solutions for the healthcare industry, is pleased to announce that it has successfully completed the following milestones.

ForeverGreen Worldwide Corporation (OTCBB: FVRG.OB)
, a leading provider of nutritional foods and other healthy products, today announced that company CEO Ron Williams traveled to Japan last week to launch new growth initiatives.

Galectin Therapeutics, Inc. (OTC: GALT)
, the leading developer of therapeutics that target galectin receptors to treat cancer and fibrosis, today announced that Dr. Peter G. Traber, Chief Executive Officer, President and Chief Medical Officer, is scheduled to present a corporate update at the BIO CEO & Investor Conference on Tuesday, February 14, 2012, at 10:30am ET at the Waldorf- Astoria Hotel in New York City.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC)
, a biotechnology company focused on the development of novel immune-based cancer therapies, announced today that its president and CEO, Manish Singh Ph.D., will be presenting at the upcoming 14th annual BIO CEO & Investor Conference at the Waldorf Astoria in New York City.

Impax Laboratories, Inc. (NASDAQ: IPXL) today provided an update on the status of its resolution of the previously disclosed warning letter issued by the U.S. Food and Drug Administration (FDA) covering its Hayward manufacturing facility.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that John Higgins, President and Chief Executive Officer of Ligand will present at the BIO CEO and Investor Conference on Monday, February 13, 2012 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time).

mPhase Technologies, Inc. (OTCBB: XDSL) announced today that it is in negotiations with a Private Equity group to invest a minimum of $2 million in mPhase.

NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company") announced today that it has received the final tranche of $2.5M from Seaside 88, LP (“Seaside”), thereby completing the total of $5M financing.

Repligen Corporation (NASDAQ:RGEN)
announced today that it will disclose preliminary financial results for the third quarter of fiscal year 2012 on Tuesday, February 21, 2012, before the market opens.

In recognition of its multi-faceted 2011-12 pharmacy immunization program, Rite Aid (NYSE: RAD) has been honored with the American Pharmacists Association's Immunization Champion Award in the national corporation/institution category.

Star Scientific (NASDAQ: CIGX) subsidiary, Rock Creek Pharmaceuticals, is pleased to announce IRB approval, and successful identification and selection of five clinical sites in Texas, Illinois and Florida for its upcoming "ASAP" (Anatabloc Supplementation Autoimmune Prevention) thyroid study.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it will webcast its corporate presentation at the 14th Annual BIO CEO + Investor Conference on Monday, February 13, 2012, at 8:30 am Eastern.

Synergy Pharmaceuticals, Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, today announced that its President and CEO, Gary S. Jacob, Ph.D, will present at the 14th Annual BIO CEO & Investor Conference.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced fourth quarter 2011 financial results for the three month period ended December 31, 2011.

UnitedHealthcare, a UnitedHealth Group (NYSE:UNH) company, has completed its acquisition of XLHealth Corporation, (XLHealth) a sponsor of Medicare Advantage health plans with a primary focus on Medicare recipients with special needs, such as those with chronic illness and those eligible for Medicaid (“dual eligibles”).

Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases and Hydra Biosciences, Inc., a leader in the discovery and development of novel ion channels, today announced that they have entered into a collaboration to advance development of Zalicus’ preclinical ion channel modulator product candidates for the treatment of pain.



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