¿ Advanced Viral Research Corp., of Yonkers, N.Y., said a scientific research paper showing that its peptide-nucleic acid immunomodulator, Product R, enhances the production of two proteins that boost the immune response during viral infection was published in Cytokine (Vol. 14, No. 4). Product R has been shown to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, the company said.
¿ Amarillo Biosciences Inc., of Amarillo, Texas, said it completed a supplemental analysis of its second Phase II trial in patients with fibromyalgia syndrome. The trial was double blinded and placebo controlled, and involved 119 patients who were treated once or three times daily with lozenges containing 50 international units of natural human interferon alpha, or placebo, for 12 weeks. The new analysis showed a difference in response between patients who had an injury that contributed to the development of their syndrome and those without a history of injury. The group that did not have an injury showed significantly greater improvement (p<0.05) compared to placebo in five variables. In eight other variables, the group with no historical injury showed improvement, although not statistically significant.
¿ Aphios Corp., of Woburn, Mass., was awarded a fast-track Small Business Innovation Research contract from the National Cancer Institute, of Bethesda, Md. The contract is meant to develop a process for the extraction and purification of potential anticancer, natural product drugs from a variety of plant, marine organism or microbial sources. The amount of the award was not disclosed.
¿ Beckman Coulter Inc., of Fullerton, Calif., and EpiVax Inc., of Providence, R.I., formed an alliance to discover, develop and commercialize products and services for the identification of biological sequences with potential for activating the immune system. The companies will combine Beckman Coulter¿s iTAg MHC Tetramers and EpiVax¿s EpiMatrix system. Beckman Coulter will market EpiVax epitope discovery services in the United States, Canada and certain European countries. Also, the companies will explore collaborating in areas of mutual interest. Beckman Coulter will consider any discoveries for commercialization.
¿ BTG plc, of London, started a Phase I trial to test AQ4N, a drug designed to increase the effectiveness of several anticancer drugs as well as radiotherapy. AQ4N is the lead compound selected from a series of hypoxic-cell cytotoxins. Additional Phase I studies are under consideration.
¿ Compugen Ltd., of Princeton, N.J., signed an agreement to license Gencarta, its annotated genome, transcriptome and proteome database and query tools to Kyowa-Hakko Kogyo Co. Ltd., of Tokyo. Financial terms were not disclosed. Kyowa-Hakko focuses on discovering, developing, manufacturing and marketing pharmaceutical products and biochemicals.
¿ DNAPrint genomics Inc., of Sarasota, Fla., entered a joint venture with DNAPRO SDN BHD, of Selangor, Malaysia, to expand DNAPrint¿s pharmacogenomics presence overseas. The joint venture is called DNAPrint genomics SDN BHD and will devote its efforts to the development of genomics-based, personalized medical products specifically geared for Malaysian, Indonesian and other Southeast Asian populations. The financial structure of the new company was not disclosed.
¿ DUSA Pharmaceuticals Inc., of Wilmington, Mass., said the FDA approved its three investigational new drug applications and gave the company clearance to proceed with Phase I/II trials. It will begin trials using Levulan Photodynamic Therapy for the treatment of nail fungus, warts and Barrett¿s esophagus, with the Barrett¿s esophagus study scheduled to begin this month.
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., held a conference call to review its inhaled insulin program. Pfizer Inc., of New York, said in its second-quarter earnings that it ¿now appears likely¿ the FDA would require additional data for a new drug application filing for Pfizer and Inhale¿s inhaled insulin formulation, Exubera, thus delaying filing. Inhale¿s stock (NASDAQ:INHL) dropped $1.64 Tuesday, or about 8 percent, to close at $18.27.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Pharsight Corp., of Mountain View, Calif., said they have entered an agreement to evaluate and apply Pharsight¿s computer-assisted trial design and decision-making methodologies to Millennium¿s drug development programs. Initially, the agreement will focus on testing and validating the utility of Pharsight¿s modeling and simulation software in Millennium¿s lead program for LDP-341, a cancer treatment in Phase II trials. Financial terms were not disclosed.
¿ Nanogen Inc., of San Diego, and Aventis Research & Technologies GmbH & Co. KG, of Frankfurt, Germany, formed Nanogen Recognomics GmbH. The new company will combine Nanogen¿s NanoChip technology and Aventis R&T¿s intellectual property and synthetic oligonucleotide chemistry and advanced molecular biology knowledge to develop products and applications for the NanoChip System. The new company is 60 percent owned by Nanogen and has 12 employees.
¿ National Institutes of Health, of Bethesda, Md., is partly funding the Osteoarthritis Initiative (OAI), a consortium that will collect information and define disease standards on 5,000 people at high risk of having osteoarthritis and at high risk of progressing to severe osteoarthritis during the course of the study. The OAI will provide about $8 million yearly for as many as six clinical research centers to establish and maintain a natural history database for osteoarthritis that will include clinical evaluation data and radiological images, and a biospecimen repository. Private funding will be supplied by Glaxo-SmithKline plc, Merck KGaA, Novartis Pharmaceuticals Corp. and Pfizer Inc.
¿ Neugenesis Corp., of San Carlos, Calif., and Genencor International Inc., of Palo Alto, Calif., initiated the second phase of a collaborative research and development project designed to improve an undisclosed industrial enzyme. The project couples Neugenesis¿ directed evolution technologies with Genencor¿s platforms for screening enzyme activities for diversity in fungal genes. Financial terms were not disclosed.
¿ Neurochem Inc., of Ville Saint-Laurent, Quebec, said it saw positive Phase I safety data for Fibrillex, its therapeutic for secondary amyloidosis. The data showed Fibrillex was well tolerated with a side effect profile comparable to placebo in both healthy and renal-impaired volunteers. Fibrillex also is in late-stage secondary amyloidosis trials, with a pivotal Phase II/III study under way.
¿ Neurocrine Biosciences Inc., of San Diego, said it received positive efficacy results in all four doses of NBI-34060 in a Phase II study in patients with chronic insomnia. The randomized, multicenter, double-blind, placebo- and active-drug-controlled, six-way crossover dose-response study involved 59 patients and had a primary endpoint of latency to persistent sleep (LPS). The compound showed a statistically significant effect on LPS relative to placebo at all dose levels (p<0.016). Also, up to 80 percent of patients fell asleep within 30 minutes. Neurocrine expects to begin pivotal Phase III trials by the fourth quarter.
¿ Nymox Pharmaceutical Corp., of Montreal, said further studies of its antimicrobial treatment, NXC 4720, by scientists at Nymox¿s collaborator, Biophage Inc., also of Montreal, showed its effect on treating E. coli 0157:H7 contamination of meat. Nymox has several drug development programs with candidate drugs for Alzheimer¿s disease and other indications.
¿ Ortec International Inc., of New York, said the General and Plastic Surgery Devices Advisory Panel of the FDA unanimously recommended approval of its substitute engineered skin, OrCel, for use in treatment of donor site wounds in burn victims. The panel recommended further histology characterizations and label clarifications for specific use in certain patient populations. Ortec filed a premarket approval application with the FDA in March. The company said it will work with the FDA to get final marketing approval of the composite cultured skin product.
¿ PTC Therapeutics Inc., of South Plainfield, N.J., was awarded a second Phase I Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md. The grant will be used to advance PTC¿s RNA-based approach for developing novel drugs that target the mechanism HIV uses to replicate. PTC developed a drug discovery program to specifically disrupt an RNA-protein interaction, called the Tat-TAR interaction, that is necessary for HIV to manufacture infectious particles.
¿ Sangamo BioSciences Inc., of Richmond, Calif., formed an agreement with Pharmacia Corp., of Peapack, N.J., to develop cell lines for small-molecule screening. Sangamo scientists will engineer a cell line to overproduce a specific protein of therapeutic importance, Sangamo said. The cell line will then be transferred to Pharmacia for use in its drug discovery screening program. The agreement includes an up-front payment to Sangamo, research funding, product development milestones and royalties. Financial terms were not disclosed.