Allos Therapeutics Inc., of Westminster, Colo., said an independent Data Safety Monitoring Committee performed an interim analysis for efficacy and recommended that the company's Phase III trial be continued. The analysis encompassed the first 344 randomized patients. Allos is conducting a pivotal Phase III trial of RSR13 (efaproxiral) for the treatment of patients with brain metastases receiving radiation therapy. The company said it intends to complete patient accrual in the second half of the year, conduct a six-month follow-up, and file a new drug application in the second half of 2003.
Artecel Sciences Inc., of Durham, N.C., and Duke University Medical Center said they transformed adult stem cells taken from fat into cells that appear to be nerve cells. It is not clear whether the new cells will function like native nerve cells, but the researchers are optimistic and feel there is the potential in the research to treat central nervous system diseases and disorders, Artecel said. The research was supported by the American College of Surgeons and by Artecel.
Avanir Pharmaceuticals Inc., of San Diego, said the Ministry of Health in Israel approved docosanol 10 percent cream for marketing as a topical treatment for cold sores. It will be marketed in Israel by CTS Chemical Industries under an exclusive license agreement that provides royalties to Avanir. CTS said it expects to begin marketing the product, which it will sell under the trade name Abrax, in October. The product received nonprescription status and will be sold over the counter. The product has been approved for marketing in the U.S., Canada and, earlier this week, Korea. A decision is pending in Europe.
Biotechnology Industry Organization, of Washington, signed a memorandum of understanding to expand cooperation between itself and NASA. The memorandum establishes three goals of collaboration: enhanced communication between NASA and the industry, expanded commercial biotechnology space research and development, and formal and informal education of industry and the public regarding biotechnology and space research. NASA will use outer space as a laboratory to test the fundamental principles of chemistry and biology, while BIO will provide support for research and commercial opportunities.
Boyce Thompson Institute for Plant Research in Ithaca, N.Y., and Cornell University identified a region present in two bacterial proteins that triggers natural immunity to speck diseases in tomato plants. The finding was published in Friday's issue of Cell. The institute said the discovery could provide leads for developing new therapies to fight human infections that are caused by bacteria such as Salmonella and E. coli.
Corixa Corp., of Seattle, and GlaxoSmithKline plc, of London, said Corixa filed a request for formal dispute resolution, appealing the position by the FDA on the approval status of Bexxar in the agency's complete review letter dated March 12. Corixa requested the opportunity to present data on the safety and efficacy of Bexxar in the treatment of relapsed or refractory low-grade and transformed low-grade non-Hodgkin's lymphoma to a meeting of the Oncologic Drugs Advisory Committee. If an appeal is granted, Corixa could provide the FDA with additional data in support of Bexxar meeting an unmet medical need. Corixa had said a few weeks ago that it would file the request. (See BioWorld Today, May 16, 2002.)
Digene Corp., of Gaithersburg, Md., said it provided additional information and documentary material responsive to a request from the U.S. Federal Trade Commission in connection with the FTC's review of the proposed acquisition of Digene by Cytyc Corp., of Boxborough, Mass. The companies received on May 24 a formal request for the information from the FTC. The proposed acquisition was originally announced in February and was valued at about $554 million. (See BioWorld Today, Feb. 20, 2002.)
Dimethaid Research Inc., of Toronto, said it closed its $37 million acquisition of Switzerland-based Oxo Chemie AG. Also, it said it extended its private placement agreement with Acqua Wellington North American Equities Fund Ltd. until Aug. 31. The original terms of the Acqua Wellington financing, a 13-month private placement for up to C$50 million (US$32.7 million), were announced in January 2001. Since then, Dimethaid has drawn down C$17.2 million. Dimethaid's drug delivery technology uses the cell's tubule system to deliver site-specific therapy.
Eli Lilly and Co., of Indianapolis, said the European Committee for Proprietary Medicinal Products issued a positive opinion on Xigris (drotrecogin alfa [activated]) for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The committee recommended to the European Commission that the approval be granted under exceptional circumstances, meaning Lilly and the committee must agree upon post-approval trial commitments, including an obligation for Lilly to provide an annual update to the agency regarding the trials. Xigris was granted approval by the FDA in November. Xigris has also been approved in Israel, Argentina, Mexico, Australia, Columbia, Romania and Peru. (See BioWorld Today, Oct. 30, 2001.)
Illumina Inc., of San Diego, signed a commercial agreement with the University of North Carolina at Chapel Hill Pulmonary and Cystic Fibrosis Research Center to provide single nucleotide polymorphism (SNP) genotyping services on a sample collection provided by the center. Illumina will design functional assays for many of the SNP loci provided by the center, then use its BeadArray technology to genotype specified SNPs in the sample set. Financial details were not disclosed.
Medivir AB, of Huddinge, Sweden, said the addition of its product, MIV-310, demonstrated a strong reduction in viral load levels in HIV patients who do not respond to treatment with present therapies. The Phase IIa trial involved 15 HIV-infected patients. MIV-310 was added to their regimen of three-to-five HIV drugs over four weeks. All patients responded positively, it said.
Millennium Pharmaceuticals Inc., of Cambridge, Mass., said preclinical research on MLN518 was published in the May 31, 2002, issue of Cancer Cell. The data from the article showed MLN518 induced cell death in acute myeloid leukemia (AML) cells containing the FLT3 mutation, as well as demonstrated inhibition of FLT3 mutation vs. other inhibitors in the same class. Also, the company said it is initiating Phase I trials in the treatment of AML to be conducted at five U.S. sites and involving about 40 patients.
NeoTherapeutics Inc., of Irvine, Calif., reported interim results from its pilot study of Neotrofin in patients with early stage Parkinson's disease. Data for 20 patients treated with Neotrofin and six patients treated with placebo had been analyzed in the first four weeks of the 12-week study. The results suggest acute efficacy in the first several weeks, when patients were receiving Neotrofin 250 mg twice daily, with a decrease in efficacy thereafter, as patients were titrated first to 500 mg twice daily, then to 1,000 mg twice daily. The patients treated with Neotrofin showed statistically significant improvement in scores on the Motor Examination from the Unified Parkinson's Disease Rating Scale within two to three hours after receiving their first 250-mg dose of Neotrofin. However, dosing with 500 mg twice daily for two weeks showed the improvement in scores was smaller and not statistically significant. The score changes among patients on placebo were not statistically significant at any time point, and were not significantly different from the Neotrofin treatment group. Dosing was subsequently continued, as tolerated, at 1000 mg twice daily during the remainder of the 12-week study period, for which data have been collected for the 26 patients but have not been fully analyzed. NeoTherapeutics decided to stop the protocol and initiate a new study in which patients will be maintained on lower doses. The new protocol also will include a larger placebo sample. NeoTherapeutics' stock (NASDAQ:NEOT) rose 14 cents Friday, or 51.9 percent, to close at 41 cents, on trading of 5.7 million shares. It traded as high as 75 cents.
Nutra Pharma Corp., of Seattle, signed a definitive agreement to acquire 100 percent of the stock of Bio Therapeutics Inc., of Plantation, Fla., in a cash and stock transaction that was valued at $50 million when the deal was announced in late April. Bio Therapeutics would receive one share of Nutra Pharma common stock for every share of Bio Therapeutics common stock, as well as funding to continue clinical trials. Bio Therapeutics was founded in 1984 and has a method for altering the 3-dimensional structure of certain proteins and peptides that results in the preservation of receptor-binding characteristics. (See BioWorld Today, May 1, 2002.)
Proteome Systems Ltd., of Sydney, Australia, released ProteomIQ, its product designed to accelerate proteomics research and the discovery of drugs to treat diseases such as cancer and infectious diseases. ProteomIQ brings together niche sample preparation and analytical technologies with computing, training and support programs, the company said.
QLT Inc., of Vancouver, British Columbia, and Novartis Ophthalmics, the eye health unit of Novartis AG, of Basel, Switzerland, said the Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency adopted a positive opinion on Visudyne therapy to include the treatment of patients with evidence of recent or ongoing disease progression in occult subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD). The opinion will be considered by the European Commission, which should make a European marketing decision within three months. Visudyne therapy is the only drug approved for the treatment of certain forms of wet AMD, the companies said.
Signase Inc., of Houston, said it is moving into its new 22,000-square-foot headquarters. The company focuses on the discovery and development of small-molecule protein tyrosine kinase inhibitors, which have applications in treating cancer and osteoporosis, as well as the regulation of immune function and central nervous system disorders.
Stem Cell Sciences Ltd., of Melbourne, Australia, and Sosei Co. Ltd., of Tokyo, formed a Japanese biotechnology company, Stem Cell Sciences KK (SCS KK), headquartered in Kobe, Japan. Licenses granted to SCS KK are for the SCS patented stem cell technologies relating to the growth, differentiation and purification of embryonic stem cells. SCS KK, among other things, will exclusively market the discovery platform technologies of SCS and those developed by SCS KK throughout Asia. SCS will market the combined technologies in all other territories, and partner with SCS KK to create stem cell-based therapies for the global market.