Acusphere Inc., of Watertown, Mass., closed its public offering of 6.5 percent convertible exchangeable preferred stock, netting about $41.5 million in proceeds. Piper Jaffray & Co. acted as the sole book-running manager, and SG Cowen & Co. and C.E. Unterberg, Towbin were co-managers. Proceeds will go toward Phase III trials with AI-700, a product designed to detect myocardial perfusion. (See BioWorld Today, Feb. 22, 2005.)
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said in vivo data presented at the Macula Society meeting in Key Biscayne, Fla., on the use of RNA interference to silence expression of vascular endothelial growth factor demonstrated that an optimized RNAi candidate led to reduced pathologic vascular leakage. In preliminary preclinical studies performed in a rat model of age-related macular degeneration with laser-induced choroidal neovascularization, the RNAi therapeutic reduced leakage compared to a placebo. The company said additional preclinical studies are ongoing to confirm that finding, determine an optimal drug dose and delivery regimen and to compare Alnylam's product to other drugs designed to treat the wet form of AMD.
American Pharmaceutical Partners Inc., of Schaumburg, Ill., said the pivotal Phase III trial of Abraxane for injectable suspension in patients with metastatic breast cancer demonstrated a statistically significant improvement in survival in second-line patients. The data were presented at the 22nd annual Miami Breast Cancer Conference. In the overall patient population, median survival for patients receiving Abraxane was 10 weeks longer than for patients receiving Taxol, but the difference did not reach statistical significance. However, patients receiving Abraxane in the second-line or greater setting displayed a significant prolongation in survival (p=0.016) compared to those receiving Taxol. The FDA approved Abraxane in January to treat breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. (See BioWorld Today, Jan. 11, 2005.)
BCY LifeSciences Inc., of Toronto, signed an agreement with Align Pharmaceuticals Inc., of Cary, N.C., to undertake further development and marketing of DCF 987. The compound is being developed for respiratory conditions, such as cystic fibrosis. BCY president and CEO Lorne Meikle said the agreement validates the company's Phase II results.
BioBalance Corp., of New York, a wholly owned subsidiary of New York Health Care Inc., said that New York Health Care has completed the closing of about $4.9 million in a private placement of newly issued shares of common stock and common stock purchase warrants to accredited investors. The closings also triggered the resignations of Jerry Braun and Jacob Rosenberg, CEO and chief operating officer, respectively, as executive officers and directors of the company.
Chemical Diversity Inc., of San Diego, said its collaboration with James Chen of Stanford University to design and evaluate compound libraries for Hedgehog pathway screens has resulted in the screening of 3,000 compounds that sample chemical diversity space, and the discovery of potential antagonists. Secondary screens are ongoing to confirm these hits and link them to known Hh pathway components.
Cytyc Corp., of Marlborough, Mass., received early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act in connection with Cytyc's acquisition of Proxima Therapeutics Inc.
Discovery Laboratories Inc., of Warrington, Pa., completed its previously announced registered direct offering, raising a total of $29.1 million in gross proceeds. The company sold about 5.1 million shares of its common stock to institutional investors at $5.75 per share. SG Cowen & Co. LLC acted as the placement agent. Discovery said net proceeds will help fund the anticipated market launch of Surfaxin, a prophylaxis therapy for respiratory distress syndrome, as well as support ongoing clinical trials and general corporate purposes. (See BioWorld Today, Feb. 22. 2005.)
Genaera Corp., of Plymouth Meeting, Pa., reported interim results of a Phase II trial of Evizon (squalamine lactate) in choroidal neovascularization associated with age-related macular degeneration at the 28th annual meeting of the Macula Society in Key Biscayne, Fla. All patients received four weekly doses of Evizon, at either 10-mg or 40-mg levels, with no further maintenance therapy. Data showed that patients receiving 40 mg had preserved or improved vision during evaluation in both affected eyes through month four, with the greatest degree of improvement reported at four months with a gain relative to baseline of 18 letters, and the greatest degree of loss was 12 letters on the ETDRS chart.
Geneva Bioinformatics SA, of Geneva, released its protein identification platform, Phenyx, which incorporates the mxData standard and improves the results comparison functionality for all versions of Phenyx. The augmented results comparison functionality permits researchers to generate a table of side-by-side results. Researchers can import results from other major software packages in order to cross-validate or consolidate their identification results.
GeneWorks, of Ann Arbor, Mich., said its scientists have confirmed the presence of a gene encoding its third pharmaceutical protein in the semen of two more transgenic roosters. To date, the company has identified 22 roosters that carry engineered genes in their semen. The achievement shows transgenic chickens can be used in producing therapeutic proteins.
ImmuneRegen Biosciences Inc., of Scottsdale, Ariz., a wholly owned subsidiary of IR BioSciences Holdings Inc., completed a pilot animal study to determine whether its Homspera substance could be used to treat asthma by blocking the development of airway hyper-reactivity. The study was performed with 23 mice, divided into cigar-smoking, cigarette-smoking and a control group and all received daily aerosol treatment of Homspera. ImmuneRegen said data, measured by the percent increase in inspiratory dynamic lung compliance between baseline and post-histamine administration, demonstrated that the treatment can attenuate the development of airway hyper-reactivity after toxic exposure to either cigarette or cigar smoke.
Memory Pharmaceuticals Corp., of Montvale, N.J., began a Phase I study in healthy volunteers of MEM 3454, a partial agonist of the nicotinic alpha-7 receptor, a specialized receptor found in the central nervous system. Memory entered a collaboration in 2003 that gives F. Hoffmann-La Roche Ltd., of Basel, Switzerland, the right to obtain an exclusive license for the product following the completion of Phase IIa trials.
Ocimum Biosolutions, of Hyderabad, India, signed a letter of intent to acquire core assets, specifically the microarray business, of MWG Biotech AG, of Ebersberg, Germany. Ocimum will take over the microarray expertise and assets of the microarray business line, including inventory and stock. The new location will be Hyderabad. Part of the services also will be offered from Indianapolis.
Provalis plc, of Deeside, UK, intends to terminate its American Depository Receipt (ADR) program and Nasdaq listing, and suspend the company's registration and reporting obligations to the SEC. Provalis said the decision was reached after reviewing the costs and management time needed to comply with recent changes in U.S. securities laws. Provalis' shares will remain listed on the London Stock Exchange.
RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said, based on recent data showing TB4's ability to protect heart tissue, the company is increasing its efforts to file an investigational new drug application to start a cardiac clinical trial before the end of the year. The company is planning several acute toxicology studies specifically focused on the myocardium to supplement its existing data. TB4 (thymosin beta 4) is a naturally occurring peptide present in all human cells.
Transgenomic Inc., of Omaha, Neb., provided an update regarding its progress with the expense reduction plan previously reported in the fourth quarter of 2004. The plan was designed to refocus the company on its BioSystems business segment and to align the company's cost structure with anticipated market opportunities and revenue streams. Consistent with the expense reduction objectives and timing disclosed in November 2003, the company has completed the work force reduction of about 60 positions and has closed two domestic research and development facilities associated with its nucleic acids operating segment and two European field offices. Aggregate charges of about $3.5 million associated with the plan are being recognized in the company's fourth quarter operating results. Transgenomic said it expects to recognize no significant additional restructuring charges.