Preclinical News and Research

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Study demonstrates once-a-week TB drug is as effective as daily dose

Researchers at the Council for Scientific and Industrial Research (CSIR) are one step closer to providing Tuberculosis (TB) sufferers with a once-a-week medicinal regime rather than their current daily doses.

18 Feb 2010

FDA issues Complete Response Letter for Horizant in treatment of RLS

GlaxoSmithKline and XenoPort, Inc. Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

18 Feb 2010

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

BioMimetic Therapeutics, Inc. today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment™ Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009.

18 Feb 2010

Athersys completes enrollment in phase I MultiStem allogeneic stem cell therapy clinical trial

Athersys, Inc. and Angiotech Pharmaceuticals, Inc. announced that Athersys has completed patient enrollment for its phase I clinical trial of MultiStem(R), its allogeneic stem cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Top line results of the trial are expected to be announced midyear, upon completion of the four-month patient follow-up visits and analysis of results.

17 Feb 2010

Senesco Technologies announces financial results for quarter ended December 31, 2009

Senesco Technologies, Inc. today reported financial results for the three months ended December 31, 2009.

17 Feb 2010

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Otonomy, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of OTO-104 in patients with Meniere's disease, a debilitating disorder of the inner ear affecting balance and hearing.

17 Feb 2010

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Marcadia Biotech Inc. today announced that it has initiated a Phase 1 clinical trial of MAR701, a novel dual agonist of the incretin hormone receptors for glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP). Marcadia plans to initially develop this compound as a treatment for type 2 diabetes with once-weekly dosing. The Phase 1 trial will evaluate MAR701 in healthy volunteers at escalating dose levels.

17 Feb 2010

Soligenix' LPM oral drug delivery technology receives Hong Kong patent

Soligenix, Inc., a late-stage biotechnology company, announced today that it has received a Hong Kong patent which addresses its Lipid Polymer Micelle (LPM™) technology for the improved oral delivery of drugs. The issued Hong Kong patent, HK 1071054, entitled "Stabilized Reverse Micelle Compositions and Uses Thereof" covers lipid structures (reverse micelles) that promote the intestinal absorption of peptides and other sensitive drugs that cannot otherwise be given orally.

17 Feb 2010

Special issue reviews current state of science in fetal therapy

Repairing birth defects in the womb. Inserting a tiny laser into the mother's uterus to seal off an abnormal blood flow and save fetal twins. Advancing the science that may allow doctors to deliver cells or DNA to treat sickle cell anemia and other genetic diseases before birth.

17 Feb 2010

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for drug dependence, smoking cessation and obesity, announced today that the company has retained Exponential Pharma Ventures LLC to assist in establishing a clinical development partnership for its cocaine dependence program with a fully integrated pharmaceutical company.

17 Feb 2010

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Alkermes, Inc. today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC).

16 Feb 2010

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

Oncolytics Biotech Inc. today announced that it has received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that the Company previously reached an agreement on with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process.

16 Feb 2010

EntreMed's ENMD-2076 for AML receives FDA's orphan drug designation

EntreMed, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company's lead oncology drug candidate, ENMD-2076, for the treatment of acute myeloid leukemia (AML).

16 Feb 2010

Octapharma initiates Phase III studies for new, high purity IVIG in treatment of primary immune deficiency

Octapharma AG today announced the start of the first of a series of Phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG). The study will investigate the efficacy and safety of this novel immunoglobulin in the treatment of primary immune deficiency and, together with results from additional upcoming studies, will support its regulatory filing in Europe and the US.

16 Feb 2010

Idera Pharmaceuticals presents TLR antagonist preclinical hyperlipidemia data at Keystone Symposia conference

Idera Pharmaceuticals, Inc. presented data on the evaluation of a Toll-like receptor (TLR) antagonist in a preclinical hyperlipidemia model today at the Keystone Symposia conference “Advances in Molecular Mechanisms of Atherosclerosis” being held in Banff, Alberta, Canada. Idera’s proprietary TLR antagonists have dual activity for both TLR7 and TLR9, and present a potentially innovative approach for the treatment of certain autoimmune diseases.

15 Feb 2010

Debiopharm receives AFSSAPS approval of CTA for Debio 0932 inhibitor, triggers milestone payment to Curis

Curis, Inc., announced today that its licensee Debiopharm S.A. has received approval from France's regulatory authority Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8 million milestone payment from Debiopharm for the achievement of this development objective.

12 Feb 2010

Better and standardized animal models needed for musculoskeletal regenerative medicine

Clinical testing and development of novel therapies based on advances in tissue engineering and regenerative medicine that will one day enable the repair and replacement of diseased or damaged human muscle, bone, tendons, and ligaments depends on the availability of good animal models.

12 Feb 2010

Second-quarter fiscal 2010 results announced by Pharmacyclics

Pharmacyclics, Inc. today reported financial results for its second fiscal quarter ended December 31, 2009.

12 Feb 2010

3SBio, Ascentage Pharma announce cancer therapeutics collaboration

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, and Ascentage Pharma Group Corporation, Ltd. ("Ascentage Pharma") announced today that they have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis. The alliance will leverage Ascentage Pharma's expertise in structure-based small molecule design, lead optimization and preclinical development with 3SBio's proven drug development and commercialization capabilities in China.

12 Feb 2010

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

Amicus Therapeutics announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida.

11 Feb 2010

Preclinical News and Research

Study demonstrates once-a-week TB drug is as effective as daily dose

FDA issues Complete Response Letter for Horizant in treatment of RLS

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

Athersys completes enrollment in phase I MultiStem allogeneic stem cell therapy clinical trial

Senesco Technologies announces financial results for quarter ended December 31, 2009

FDA clears Otonomy's IND for clinical trial of OTO-104 in Meniere's disease patients

Marcadia Biotech commences Phase 1 clinical trial of MAR701 for type 2 diabetes

Soligenix' LPM oral drug delivery technology receives Hong Kong patent

Special issue reviews current state of science in fetal therapy

Embera NeuroTherapeutics establishes clinical development partnership for its cocaine dependence program

Positive topline data from Alkermes' phase 1 clinical study of ALKS 37 announced

Oncolytics Biotech receives U.K. MHRA approval for REOLYSIN combination Phase 3 trial

EntreMed's ENMD-2076 for AML receives FDA's orphan drug designation

Octapharma initiates Phase III studies for new, high purity IVIG in treatment of primary immune deficiency

Idera Pharmaceuticals presents TLR antagonist preclinical hyperlipidemia data at Keystone Symposia conference

Debiopharm receives AFSSAPS approval of CTA for Debio 0932 inhibitor, triggers milestone payment to Curis

Better and standardized animal models needed for musculoskeletal regenerative medicine

Second-quarter fiscal 2010 results announced by Pharmacyclics

3SBio, Ascentage Pharma announce cancer therapeutics collaboration

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

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