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Other News To Note
(BioWorld Today Via Thomson Dialog NewsEdge) , of Laguna Niguel, Calif., said data published in Free Radical Research showed the company's lead compound, AEOL 10150, provided statistically significant protection of the lungs of Fisher 344 rats exposed to fractionated radiation. The study also demonstrated that the compound reduced markers for tissue hypoxia, angiogenesis, inflammation and oxidative stress in rats studied in the experiment.
? Affymetrix Inc., of Santa Clara, Calif., extended its Collaborations in Cancer Research Program to North America, forming an alliance with 25 cancer researchers. All of the researchers in the program are using Affymetrix' integrated genomics solution to accelerate research on more than 10 types of cancer.
? Ardea Biosciences Inc., of San Diego, presented preclinical data on the company's next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) family of compounds demonstrating activity against HIV, including NNRTI- resistant strains. The data were presented at the 21st International Conference on Antiviral Research (ICAR) in Montreal. The compounds are active against both wild-type and the most common NNRTI-resistant viruses and are more active than efavirenz and nevirapine against a broad panel of NNRTI-resistant clinical isolates.
? ArQule Inc., of Woburn, Mass., appointed Paolo Pucci CEO and a member of the board. Pucci previously was at Bayer AG as senior vice president and president of the Bayer-Schering Pharmaceuticals Global Oncology/Specialized Therapeutics Business Units.
? Commonwealth Biotechnologies Inc., of Richmond, Va., entered a global alliance with New Zealand Pharmaceuticals Ltd., of Palmerston North, New Zealand, to provide a suite of small-molecule chemistry products for the drug discovery and development market. The alliance will focus on providing scale-up and commercialization by way of an exclusive referral and co-marketing agreement. CBI, through wholly owned subsidiary Exelgen Ltd., will provide customers with research-grade products and services and NZP will supply identified lead candidates for preclinical applications through to cGMP products for clinical and therapeutic applications.
? Eurand NV, of Philadelphia, said that Chiesi Farmaceutici SpA, of Palermo, Italy, has granted Eurand Pharmaceuticals Inc., an Affiliate of Eurand NV, an exclusive license to its gastro-resistant, controlled-release tablet formulation of the corticosteroid, beclomethasone dipropionate, in the U.S. and Canada. Eurand will make an up-front payment and commercial milestone payments to Chiesi Farmaceutici, primarily contingent upon obtaining U.S. regulatory approval. In addition, Eurand will pay royalties on net sales of the product. The product, marketed in Europe as Clipper 5 mg tablets, is an enteric-coated, controlled-release formulation of beclomethasone dipropionate marketed in Europe for use in the treatment of ulcerative colitis.
? Geron Corp., of Menlo Park, Calif., received a $1.5 million milestone payment from Exeter Life Sciences Inc., of Phoenix, triggered by the final risk assessment released by the FDA addressing food products made from cloned animals or their progeny. The risk assessment concluded that "consumption of such food products poses no greater risk than consumption of food products from animals produced by conventional breeding methods," Geron said.
? Helicos BioSciences, of Cambridge, Mass., has entered into a research collaboration with City of Hope focused on cancer molecular diagnostics. City of Hope will use Helicos' True Single Molecule Sequencing technology to examine known cancer-associated gene variants and the potential discovery of new mutations within those genes.
? Kiadis Pharma, of Amsterdam, the Netherlands, said the FDA has granted orphan drug designation to Rhitol, its product for the treatment of chronic graft-vs.-host disease. The company anticipates starting a Phase III study of Rhitol later this year.
? Lev Pharmaceuticals Inc., of New York, has formally submitted its complete response to the FDA approvable letter for the company's lead product candidate, Cinryze (C1 inhibitor). Lev is seeking marketing approval for Cinryze for both the acute and prophylactic treatment of hereditary angioedema, also known as C1 inhibitor deficiency. The FDA requested information on chemistry, manufacturing and controls, as well as additional analyses of existing efficacy data from Cinryze trials. No additional safety information and no additional clinical trials have been requested to date. Separately, Lev has entered into a supply agreement with Plasma Centers of America LLC to construct and purchase a maximum of three plasma collection centers in the U.S. with exclusive rights to make periodic purchases of U.S. source plasma from each new collection center through Dec. 31, 2010.
? Novelos Therapeutics Inc., of Newton, Mass., said an article in the April 15, 2008, issue of Cancer Research described findings in cellular and animal model systems that demonstrated the ability of NOV-002 to influence redox balance in and around cells, resulting in a constellation of effects on redox-sensitive cell processes and functions. NOV-002 is in an ongoing pivotal Phase III trial for non-small-cell lung cancer under a special protocol assessment and fast-track designation, and is in Phase II trials for other oncology indications.
? Oncolin Therapeutics Inc., of Houston, said one of its lead drug candidates has shown in preclinical testing that it extends the life of animals that have human tumors implanted in their brains. The early testing yielded results in animals that are equivalent to that of Temodar, which is one of the leading cancer treatments for brain cancer, the company said. Further studies determined that the administration of a combination of the compound with Temodar produces superior antitumor activity when compared to Temodar alone, resulting in increased survival, the company said. A Phase I trial is planned for early 2009.
? Pfizer Inc., of New York, said the offering period of the tender offer to purchase all of the outstanding shares of common stock of Encysive Pharmaceuticals Inc., of Houston, expired April 14. It said 85.33 percent of the outstanding shares were purchased. Pfizer will acquire all of the remaining outstanding shares by means of a merger under Delaware law.
? Phase Bioscience Inc., of Research Triangle Park, N.C., named Christopher Prior CEO and a member of the board. Most recently, Prior was founder, president and chief scientific officer of BioRexis Pharmaceuticals, which was acquired by Pfizer in 2007. He was also the founder and president of Principia Pharmaceuticals and a senior executive at Human Genome Sciences after its acquisition of Principia.
? ProtAffin Biotechnologie AG, of Graz, Austria, said it has commenced a research and development collaboration with Intercell AG, of Vienna, Austria. Under the terms of the collaboration, ProtAffin will use its expertise and know-how in functional proteomics to assist Intercell in validating potential vaccine antigens for undisclosed bacterial organisms.
? Q Therapeutics Inc., of Salt Lake City, and the Buck Institute have agreed to collaborate on novel routes to combat Parkinson's disease. They will use their expertise in differentiating stem cells to provide key cell types needed to study the disease. Those neural-lineage cell lines will be used to further research aimed at the use of various stem and progenitor cells as a potential treatment for Parkinson's disease.
? Senesco Technologies Inc., of New Brunswick, N.J., announced further details of its preclinical pancreatic islet cell research with its Factor 5A technology. Using a small interfering RNA (siRNA) against Senesco's Factor 5A technology, the data showed promising results regarding delivery of the technology as well as increased islet function and protection. The siRNA was delivered intraperitoneally, but still was shown to have significant penetration into isolated islets. Once delivered, the siRNA allowed treated islet cells to produce 30 percent to 40 percent more insulin than untreated cells. That increased insulin production also was seen in cells that were further stressed by the presence of pro-inflammatory cytokines. Treated cells also exhibited inducible nitric oxide synthase protein control. The data, which was generated by Raghavendra Mirmira at Indiana University School of Medicine, suggested that siRNA against Factor 5A may be a viable therapeutic target for preserving islet function under conditions of inflammation.
? SIGA Technologies Inc., of New York, announced that its subsidiary, SIGA Pharmaceuticals Ltd., has qualified as a small and medium-sized enterprise (SME) with respect to its application for the approval of ST-246 in Europe. ST-246 is a smallpox antiviral and SIGA's lead product candidate. SIGA also has initiated the process for obtaining marketing authorization for ST-246 with the EMEA. SME provides qualified companies with scientific advice and protocol assistance in the development of new medical products. SME status will entitle SIGA to certain fee reductions or deferrals, including reduced fees for scientific advice and certain administrative services of the EMEA, and a deferral of the fee payable for an application for marketing authorization.
? Somaxon Pharmaceuticals Inc., of San Diego, said the FDA has accepted for filing the company's new drug application for Silenor (doxepin hydrochloride). Somaxon is seeking marketing approval of Silenor for the treatment of insomnia. Somaxon expects that the FDA will complete its review and provide an action letter with respect to the NDA by Dec. 1.
? StemCells Inc., of Palo Alto, Calif., said the U.S. Patent and Trademark Office has upheld two of the company's neural stem cell patents, with minor amendments, thus rejecting arguments raised by Neuralstem Inc., of Rockville, Md., in re-examination petitions it filed last year. The upheld patents have been licensed exclusively by StemCells and claim methods for proliferating neural stem and progenitor cells and for using these cells as transplantation therapeutics. The patents are two of four which are the basis of a patent infringement suit initiated by StemCells against Neuralstem in 2006. In late 2006 and early 2007, Neuralstem petitioned the USPTO to re-examine all four of the litigated patents.
? SynCo Bio Partners BV, of Amsterdam, the Netherlands, has signed a master services agreement with OncoMed Pharmaceuticals, of Redwood City, Calif., under which SynCo will fill and finish batches of OncoMed's lead product, antibody OMP-21M18, a monoclonal antibody, which is scheduled to enter the clinic in 2008 for use in Phase I trials.
? Znomics Inc., announced the launch of a program to find lead drug compounds for the treatment of obesity. The company obtained from Oregon Health & Science University an exclusive biological license to a genetic model of obesity using the zebrafish. The company intends to refine that obesity model for use in the screening of small-molecule compounds. The company also aims to identify pre-clinical drug candidates for obesity and to partner with a pharmaceutical or biotechnology company to advance such candidates into human clinical studies.
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