Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase I study of ACE-536, a ligand trap designed to increase red blood cells and hemoglobin by inhibiting member of the TGF-beta superfamily involved in late stages of erythropoiesis...Ascendis Pharma A/S, of Copenhagen, Denmark, said a Phase II study of ACP-001 in growth hormone-deficient adults met all primary and secondary endpoints, the primary endpoint being the change in IGF-I levels from baseline compared to daily growth hormone

In patients who achieved clinical success but had recurrence, the mean degree of contracture had yet to return to pre-treatment levels after three years...Pfizer Inc., of New York, previewed data on oral JAK inhibitor tofacitinib to be presented at next month's American College of Rheumatology annual meeting, including new data from three Phase III trials (ORAL Standard, ORAL Scan and ORAL Step) and meta-analyses across the Phase III program

Clinical response data was reported for 53 patients and showed a composite complete remission rate (CRc) of 45 percent, with the majority of CRc cases represented by complete remission with incomplete hematologic recovery and no CRs observed in the first 84 days...BrainStorm Cell Therapeutics Inc., of New York, and CNS Therapeutics Inc., of St. Paul, Minn., began a Phase I/II trial at the Hadassah Medical Center in Jerusalem to evaluate BrainStorm's NurOwn treatment for patients with amyotrophic

The drug was previously included as part of a six-year option agreement with GlaxoSmithKline plc, but the big pharma passed on the compound in 2008...The South San Francisco-based firm raised $165 million a few months later to push cabozantinib through clinical trials. (See BioWorld Today, Dec. 6, 2010, and March 11, 2011.) The results of initial trials seemed to garner mixed feedback at ASCO...Astellas Pharma Global Development Inc., of Deerfield, Ill., said AGS-1C4D4 reduced tumor formation and

NovaDel Pharma Inc., of Bridgewater, N.J., opened an investigational new drug application with the FDA for Duromist, an oral spray formulation of New York-based Pfizer Inc.'s Viagra (sildenafil) for erectile dysfunction

The New York-based big pharma, which paid $50 million in cash and equity up front and would have owed up to $390 million more in milestones, cited reprioritization as its reason to return rights last fall, despite the drug's impressive Phase II data in GBM. (See BioWorld Today, Sept. 7, 2010.) Analysts have estimated that the Phase III rindopepimut program could run Celldex about $50 million...Antares Pharma Inc., of Ewing, N.J., closed an underwritten public offering of 12.5 million shares of

VistaGen's platform, known as Human Clinical Trials in a Test Tube, actually combines several stem cell technologies, including those developed by Gordon Keller, who heads up VistaGen's scientific advisory board and works out of a lab at the University Health Network's McEwen Centre for Regenerative Medicine in Toronto...It also has a clinical-stage candidate, AV-101, an oral prodrug designed to convert in the brain into active metabolite 7-chlorokynurenic acid, an agonist of N-methyl-D-aspartate

BioAlliance Pharma SA, of Paris, updated its preliminary survival data from Livatag (doxorubicin Transdrug) in hepatocellular carcinoma, with Phase II follow-up results showing a median survival of 32 months in the Livatag group compared to 15 months for patients receiving best of care...Intercept Pharmaceuticals Inc., of New York, reported positive results from a 59-patient, Phase II trial of obeticholic acid (OCA) given as monotherapy in primary biliary cirrhosis

The study is part of a 2009 collaboration between Athersys and New York-based Pfizer Inc...Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said partner ChronTech Pharma AB (formerly Tripep AB), of Stockholm, Sweden, started a Phase IIb study of its ChronVac-C DNA vaccine in hepatitis C virus delivered using Inovio's electroporation DNA vaccine delivery technology, in combination with standard of care...In addition to safety, the trial will measure defined clinical endpoints, such as changes in

The specialty pharma company, which previously hoped to sell 5.77 million shares between $12 and $14 per share, now plans to raise about $40 million by selling 8 million shares at $5 each...Ziopharm Oncology Inc., of New York, completed its public offering of 9.6 million shares, with underwriter Barclays Capital Inc...Net proceeds from the offering were about $59.4 million and are expected to fund drug development and clinical trial expansion. (See BioWorld Today, Feb. 4, 2011.)

Staff Writer Tranzyme Pharma Inc., of Durham, N.C., filed for a proposed $75 million initial public offering to support clinical development of product candidates ulimorelin and TZP-102 for the treatment of acute (hospital-based) and chronic gastrointestinal motility disorders...NeoStem, Inc., of New York, closed two concurrent offerings and received $19.2 million in gross proceeds...The company said it is focused on two key ion channel targets against which it has already developed a pipeline of

Acceleron Pharma Inc., of Cambridge, Mass., presented interim results from the first-in-human Phase I trial of angiogenesis inhibitor ACE-041 that showed clinical efficacy in end-stage cancer patients, the company said...Ziopharm Oncology Inc., of New York, announced that preclinical data on darinaparsin (Zinapar, or ZIO-101) demonstrated potent efficacy effects in various solid tumor models

7TM Pharma A/S completed a Phase I trial of its first-in-class CB1 receptor antagonist, TM38837, for obesity...Data were presented at the Chemotherapy Foundation Symposium in New York...Astex Therapeutics, of Cambridge, UK, will report clinical data on three anticancer candidates at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Nov. 16-19 in Berlin

Horizon Pharma Inc., of Northbrook, Ill., said results from a long-term safety study of HZT-501, a single-tablet formulation of ibuprofen and high-dose famotidine, showed that the drug's safety was comparable to ibuprofen alone...Tonix Pharmaceuticals Inc., of New York, said results of a new analysis from a Phase IIa study showed that bedtime administration of very low dosage cyclobenzaprine was associated with reductions in an objective measure of non-REM sleep instability, and those reductions

Action Pharma A/S, of Aarhus, Denmark, initiated Phase IIb trials of its investigational drug AP214 by administering the first dose to a patient...Genta Inc., of Berkeley Heights, N.J., initiated Phase IIb trials of tesetaxel for metastatic breast cancer at memorial Sloan-Kettering Cancer Center in New York, and at the Accelerated Community Oncology Research Network, in Memphis, Tenn...Of 22 subjects who were evaluable for anemia response, nine, or 41 percent, had achieved clinical improvement

Pfizer Inc., of New York, reported data showing that 57 percent of ALK-positive advanced non-small-cell lung cancer patients treated with crizotinib (PF-02341066), an investigational oral anaplastic lymphoma kinase (ALK) inhibitor, had either a complete or partial response to treatment...Verona Pharma plc, of London, started a clinical trial of VRP700 for chronic cough

The pharma firm will cover all development and sales costs, while OncoGenex banked $20 million up front, a $10 million equity investment and could receive up to $370 million in milestones plus tiered royalties in the largely back-end-loaded deal. (See BioWorld Today, Dec. 22, 2009.) Nearly all of investors' focus on OncoGenex has been in prostate cancer program, due to the promising midstage data and the overall excitement in the prostate cancer space following this year's approval of Dendreon

Data were presented at the International Congress of the Growth Hormone Research Society and the Insulin-like Growth Factors Society meeting in New York...Archimedes Pharma US Inc., of Bedminster, N.J., reported results from a pivotal study showing that Fentanyl Pectin nasal spray for breakthrough cancer pain met its primary endpoint in demonstrating a significant difference in summed pain intensity difference 30 minutes after dosing

Results also demonstrated statistically significant improvements in clinical symptom scores and reductions in the incidence of bronchiolitis obliterans syndrome...Keryx Biopharmaceuticals Inc., of New York, initiated a long-term Phase III trial of iron-based phosphate binder Zerenex (ferric citrate) for dialysis patients with end-stage renal disease