Therapeutics News and Research

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CrystalGenomics to present Phase I MAD study data at Arrowhead Summit

CrystalGenomics, Inc. and CG Pharmaceuticals, Inc. a drug discovery and development biopharmaceutical company, has announced that Dr. William Schmidt, its Vice President of Clinical Development, has been invited to present a talk on Development of CG100649, Tissue-selective Dual Inhibitor of COX-2 and Carbonic Anhydrase for Treatment of Osteoarthritis at Arrowhead's upcoming 4th Annual Pain Therapeutics Summit, to be held on October 4-5, 2010 in Philadelphia.

5 Oct 2010

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Celldex Therapeutics, Inc. today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

5 Oct 2010

FDA awards $2.9 million to support tuberculosis research projects

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Enzo Biochem, Inc., announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI).

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

Agile Therapeutics, Inc., a pharmaceutical development company specializing in women's healthcare products, today announced the Company has completed patient enrollment in its pivotal, Phase 3 NEW CHOICE Study of AG200-15, Agile's lead contraceptive patch. Agile's NEW CHOICE Study enrolled 1500 women at over 100 sites throughout the U.S. The study is comparing the efficacy and tolerability of AG200-15 to a low-dose, oral contraceptive.

4 Oct 2010

IRSF awards $1.5M in research grants for Rett syndrome treatment

The International Rett Syndrome Foundation (IRSF) announced today that it will award an additional $1.5M in research grants, bringing the 2010 total to $2.15 million for innovative basic and translational research that moves treatments for Rett syndrome a step closer to the clinic.

4 Oct 2010

NIH to award $64M under Transformative Research Projects program

The National Institutes of Health will award up to $64 million over five years to encourage exploration of exceptionally innovative and original research ideas that have the potential for extraordinary impact.

4 Oct 2010

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) will be presented at the Ninth International Kidney Cancer Symposium (IKCS) in Chicago, Illinois, October 1-2, 2010.

4 Oct 2010

New American Therapeutics acquires U.S. rights to market Denavir drug

New American Therapeutics, Inc., announced today that it acquired all U.S. rights to manufacture, market and sell the antiviral topical drug Denavir owned by Novartis.

4 Oct 2010

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Isotechnika Pharma Inc. announces that the results of the CONFIRM1 clinical trial conducted by its medical device partner, Atrium Medical Corporation, were presented by Glenn Van Langenhove, MD, PhD (Middelheim Hospital in Antwerp, Belgium), the principal investigator, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 Scientific Symposium in Washington, DC last week.

3 Oct 2010

Argos' AGS-003 in combination with sunitinib demonstrates favorable PFS for renal cell carcinoma

Argos Therapeutics announced that its Arcelis immunotherapy for renal cell carcinoma (RCC), AGS-003, demonstrated favorable progression-free survival (PFS) and safety in combination with sunitinib, based upon updated results from an ongoing Phase 2 trial.

1 Oct 2010

Noven acquires global rights to Daytrana from Shire affiliates

Noven Pharmaceuticals, Inc. today announced that it has completed the acquisition of global rights to Daytrana® (methylphenidate transdermal system) from affiliates of Shire plc.

1 Oct 2010

Chelsea prices common stock public offering

Chelsea Therapeutics International, Ltd. announced today that it has priced a public offering of approximately 7.14 million shares of its common stock at a price of $4.90 per share which will result in gross proceeds of $35 million. Net proceeds to the company, after underwriting discounts and commissions and expenses, will be approximately $32.8 million.

1 Oct 2010

Researchers study potential of menstrual blood-derived stem cells for stroke therapy

The potential for stem cells derived from menstrual blood to benefit stroke sufferers will be jointly investigated by researchers at the University of South Florida, Cryo-Cell International, Inc., a global stem cell company based in Oldsmar, FL, and Saneron CCEL Therapeutics, Inc. a Tampa-based biotechnology company.

1 Oct 2010

Albert Einstein College of Medicine receives grant to study role of proteins in health and disease

The National Institute of General Medical Sciences (NIGMS) has awarded Albert Einstein College of Medicine of Yeshiva University a five-year, $30 million grant to study the structure and function of thousands of biomedically important proteins.

1 Oct 2010

Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has initiated a phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of AVL-292, a novel, orally available, covalent drug that targets Bruton's tyrosine kinase (Btk). AVL-292 is the first product candidate to enter clinical evaluation from Avila's proprietary covalent drug platform, Avilomics™.

30 Sep 2010

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that AVEO has regained worldwide rights from Merck (through its subsidiary, Schering Corporation) to develop and commercialize AV-299 (also known as SCH 900105), its anti-hepatocyte growth factor (HGF) antibody candidate.

30 Sep 2010

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

Repros Therapeutics Inc. today announced that the Company has been granted a Type B meeting to be held on November 8, 2010 with the Division of Reproductive and Urologic Products to review the Company's Phase III pivotal efficacy protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

30 Sep 2010

Therapeutics News and Research

CrystalGenomics to present Phase I MAD study data at Arrowhead Summit

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

FDA awards $2.9 million to support tuberculosis research projects

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Agile completes enrollment in AG200-15 Phase 3 contraceptive patch study

IRSF awards $1.5M in research grants for Rett syndrome treatment

NIH to award $64M under Transformative Research Projects program

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

New American Therapeutics acquires U.S. rights to market Denavir drug

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Argos' AGS-003 in combination with sunitinib demonstrates favorable PFS for renal cell carcinoma

Noven acquires global rights to Daytrana from Shire affiliates

Chelsea prices common stock public offering

Researchers study potential of menstrual blood-derived stem cells for stroke therapy

Albert Einstein College of Medicine receives grant to study role of proteins in health and disease

Avila commences AVL-292 Phase 1 clinical study for B cell cancers and autoimmune diseases

AVEO regains global rights for development, commercialization of AV-299 anti-HGF antibody candidate

FDA grants Type B meeting to review Phase III pivotal efficacy protocols for Androxal

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