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Other News To Note(BioWorld Today Via Acquire Media NewsEdge) , of Bothell, Wash., presented preclinical data from a study of a blinding eye disease called retinopathy of prematurity (ROP) demonstrating an improvement in retinal abnormalities following treatment with the company's visual cycle modulation compound. The preclinical study was conducted in an animal model for ROP. The animals were given the visual cycle modulator (a derivative of vitamin A) plus a vehicle, or a vehicle alone, and then monitored for 60 days. The drug was shown to be safe, and it demonstrated a significant improvement in retinal blood vessels in the drug-treated group compared with the group that received a vehicle alone. The data were presented at the Association for Research in Vision and Ophthalmology meeting in Fort Lauderdale, Fla. ? Acusphere Inc., of Watertown, Mass., submitted a new drug application to the FDA for approval to market its lead product candidate, Imagify (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease. The company said Imagify is the first ultrasound imaging agent to demonstrate clinically equivalent accuracy to nuclear stress testing. The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multicenter Phase III trials, RAMP-1 and RAMP-2. ? Benitec Ltd., of Melbourne, Australia, said the City of Hope in Duarte, Calif., has granted it an option to obtain an exclusive worldwide license to a suite of patent rights that underpin its HIV/AIDS lymphoma RNAi therapeutic currently undergoing clinical trials. If the option is exercised, City of Hope will grant Benitec an exclusive, worldwide royalty-bearing license under pre-defined terms to research and develop, manufacture, use, offer for sale, import and sell products in the field. The pilot study is Benitec's first human trial and uses a triple therapy delivered using a lentiviral vector for the treatment of HIV. The rHIV7-shl-TAR-CCR5RZ vector suppresses HIV by expressing three therapeutic nucleic acids that are directed against key steps in HIV replication. ? BioSeek Inc., of Burlingame, Calif., initiated a research collaboration with Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, to use BioSeek's BioMAP Systems to further evaluate selected compounds associated with several of Lexicon's drug discovery programs. Financial terms were not disclosed. ? Compugen Ltd., of Tel Aviv, Israel, announced the discovery and experimental verification of CGEN-438, a potential blood-based biomarker for lung cancer. CGEN-438 is novel splice variant peptide of delta-like protein 3 precursor (DLL3). The Compugen-discovered biomarker is a peptide secreted from the cell into the bloodstream, whereas the previously known DLL3 is a protein located on the cell membrane. Initial clinical evidence indicated that the molecule potentially could serve as both a serum biomarker for the diagnosis of small-cell lung cancer and as a component in a biomarker combination for the diagnosis of non-small-cell lung cancer patients. A patent application covering this biomarker has been filed by Compugen. ? Crucell NV, of Leiden, the Netherlands, signed a nonexclusive STAR research license agreement allowing Toyobo Gene Analysis Co. Ltd., of Osaka, Japan, to evaluate the STAR technology for generating cell lines for the production of recombinant proteins for third-party customers. Financial terms were not disclosed. ? DeCode Genetics Inc., of Reykjavik, Iceland, reported that a team of scientists discovered five single-letter variants at five different sites in the human genome that impact bone mineral density and predispose to fracturing of bones. The team analyzed more than 300,000 SNPs across the genomes of some 10,000 Icelandic participants, mainly women, and replicated its findings in cohorts of about 4,000 Danish and Australian participants. Details of that discovery were published April 29 in the early online version of the New England Journal of Medicine. ? DOR BioPharma Inc., of Ewing, N.J., has initiated a comprehensive program to evaluate the efficacy of RiVax in nonhuman primates. RiVax is a vaccine against ricin toxin. The program, funded in large part by the National Institute of Allergy and Infectious Diseases, is intended to supply efficacy data for RiVax in vaccinated rhesus monkeys (macaques) and to develop correlates of immunity. Those data will further aid in interpretation of immunogenicity data obtained in human vaccination trials. ? Emisphere Technologies Inc., of Cedar Knolls, N.J., said it has been notified by Nasdaq that the firm's market value had been below the minimum $50 million requirement for continued inclusion on the global market. The company has until May 22 to regain compliance. ? Hana Biosciences, of South San Francisco, said it has received notice from Nasdaq that the company has regained compliance with the market rule relating to the maintenance of a minimum $1 bid price of the firm's common stock. ? International Stem Cell Corp., of Oceanside, Calif., said it has entered into an exclusive agreement with CellSystems Biotechnologie Vertrieb GmbH, of Germany, to distribute laboratory-cultured models of human skin useful for testing the hazardous properties of consumer products and for dermatological and pharmaceutical research. Such testing is likely to be required soon for certain types of consumer products sold into the EU, the firm said. ? Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the Federal Trade Commission granted early termination of the Hart-Scott-Rodino waiting period for its acquisition by Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. Millennium agreed to be bought by Takeda earlier in an all-cash deal priced at $25 per share, or about $8.8 billion. The firm, which sells Velcade for multiple myeloma, is expected to operate as a wholly owned subsidiary of Takeda once the deal closes. (See BioWorld Today, April 11, 2008.) ? Noven Pharmaceuticals Inc., of Miami, said its board of directors has appointed Peter C. Brandt president and CEO and to its board. As CEO, Brandt succeeds Interim CEO Jeffrey F. Eisenberg, who will remain with Noven as executive vice president. Brandt spent 28 years at Pfizer Inc., most recently as president of its U.S. pharmaceuticals operations. ? ProBioGen AG, of Berlin, signed a production deal with Ingelheim, Germany-based Boehringer Ingelheim GmbH under which it will integrate some of BI's technologies to accommodate a seamless process and technology transfer from pilot and median-scale to commercial-scale production capacities. Financial terms were not disclosed. ? Rigel Pharmaceuticals Inc., of South San Francisco, said its lead product candidate, R788, has successfully treated lupus-prone mice and significantly improved their survival, as reported in a recently published study in Arthritis and Rheumatism. R788 (fostamatinib disodium) is an orally bioavailable syk kinase inhibitor, which has shown clinically significant results in treating patients with rheumatoid arthritis and immune thrombocytopenic purpura in clinical trials. A third clinical trial in patients with B-cell lymphoma will be completed later this year. Rigel also expects to initiate a Phase II clinical trial in lupus in the second half of 2008. ? Roche Diagnostics, of Penzberg, Germany, and Biotecon Diagnostics GmbH, of Potsdam, Germany, have entered into a licensing agreement concerning Roche's LightCycler system technology. Under the terms of the agreement, Roche grants a nonexclusive worldwide license to Biotecon authorizing the company to develop, produce and sell kits in the food and genetically modified organisms analysis field that are designed for use on the Roche LightCycler Instrument. The agreement includes the use of Roche's melting curve analysis technology. Financial terms were not disclosed. ? Scil Technology GmbH, of Martinsried, Germany, and Medtronic Inc., of Memphis, Tenn., signed a development, licensing and supply agreement for joint development of Scil's biologic dental regenerative materials for use in dental implant bone restoration and treatment of periodontal disease. Under the terms, Scil will handle research and development, while Medtronic takes care of clinical trials, regulatory approvals and commercialization. Financial terms were not disclosed. ? SIGA Technologies Inc., of New York, said it has begun negotiations with the National Institute of Allergy and Infectious Diseases to obtain supplemental funding for its existing $16.5 million contract for the development of its smallpox antiviral drug candidate, ST-246. The potential award would be used to accelerate several processes related to large-scale manufacturing and packaging of the drug. ? Summit Corp. plc, of Oxford, UK, reported positive data from its preclinical development program targeting Duchenne's muscular dystrophy (DMD), showing that SMT C1100 significantly increased the strength of muscles when compared to no treatment in an in vivo DMD model. A benefit in reducing muscle fatigue during exercise was seen with the drug in combination with steroid treatment. Data were presented at the New Directions in Muscle Biology and Diseases conference in New Orleans. ? Unigene Laboratories Inc., of Fairfield, N.J., said the FDA has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in fortical, Unigene's nasal spray product for the treatment of osteoporosis. That is the second improvement to the production process approved by the FDA this year. The combination of those improvements is expected to increase batch yields of the product by a factor of three. ? ? Copyright ? 2008 Thomson BioWorld, All Rights Reserved. |