¿ Advanced Tissue Sciences Inc., of La Jolla, Calif., said its human-based tissue was featured in a presentation during the American Academy of Periodontology meeting, held this week in Philadelphia. In a study of more than 20 patients, Advanced Tissue¿s core product, fibroblast cells grown on a bioabsorbable scaffold, demonstrated equivalence to autologous palatal grafts in a within-patient paired comparison trial. One side of the patient¿s mouth was treated with the tissue-engineered product, and the other with a palatal graft harvested from the roof of the patient¿s mouth.
¿ Anadys Pharmaceuticals Inc., of San Diego, and Aventis Pharma SA, of Strasbourg, France, completed a three-year initial collaboration relating to identification of novel fungal targets, assay development and screening for these targets. The companies also are extending their collaboration to include Anadys¿ new assay development and screening platform. The affinity-based ligand screening platform is designed to be fully automated and to operate in ultra-high-throughput screening mode at a lower cost per assay point.
¿ Arius Research Inc., of Toronto, completed its previously announced rights offering. Rights were exercised for 756,000 common shares, approximately 75 percent of the maximum number allowable, for gross proceeds to Arius of $C2.65 million (US$1.7 million). These proceeds will be added to the company¿s working capital for use in ongoing operations and the development and commercialization of ARvitamab, its lead therapeutic antibody.
¿ Biomax Informatics AG, of Martinsried, Germany, launched its Gene Expression Analysis Suite, software designed to analyze gene expression data from different experiments. The software provides analysis of data sets using available gene annotation, enabling users to locate groups of tightly co-expressed genes, evaluate metabolic pathways and predict interactions among corresponding proteins.
¿ Cell Pathways Inc., of Horsham, Pa., presented early data from a Phase IIa study of CP461, an oral drug, in previously untreated chronic lymphocytic leukemia patients. Of 15 patients who received CP461 at a daily dose of 400 mg, nine showed a reduction from baseline. Six of the nine patients achieved reductions of 30 percent to 48 percent. Encouraged by the early indications of anticancer activity, Cell Pathways is entering six more patients for treatment at a daily dose of 800 mg.
¿ Cel-Sci Corp., of Vienna, Va., presented data for its immunotherapy drug Multikine jointly with the Institute for Human Virology at the University of Maryland during the meeting of the International Society for Interferon and Cytokine Research in Cleveland. The company said all five HIV-infected women with human papillomavirus-induced cervical dysplasia showed clinical improvement. Three out of four had no evidence of dysplasia on biopsy seven to eight weeks after the final injection, while biopsies on the fourth showed no apparent changes in her dysplasia. A pivotal trial is planned for next year.
¿ DNA Sciences Inc., of Fremont, Calif., is partnering with Bristol-Myers Squibb Co., of New York, to investigate genetic variants within a potential gene target. DNA Sciences will use its high-throughput sequencing and genotyping facility to study the BMS gene in normal and affected disease populations. Financial terms were not disclosed.
¿ Drug Royalty Corp. Inc., of Toronto, acquired a new royalty interest in worldwide sales of Warren, N.J.-based Celgene Corp.¿s Thalomid for $4.7 million. The term of the agreement is tied to issued U.S. patents, the latest of which will expire no later than 2015. Thalomid has shown promise in a range of indications, primarily in the cancer field, including multiple myeloma, colorectal cancer, myelodysplastic syndrome and renal cell cancer.
¿ Esperion Therapeutics Inc., of Ann Arbor, Mich., received approval to begin a Phase I study of ETC-642, its RLT Peptide product candidate, in patients with existing cardiovascular disease. The program, a single-dose study of patients with stable atherosclerosis, will begin next month. Conducted by the Mayo Clinic, the trial will determine the safety, tolerability, pharmacokinetics and lipid effects of ETC-642.
¿ Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered into an agreement with New York-based Pfizer Inc. to give Pfizer selected data from Genaissance¿s Hap Database, a collection of markers of gene variations. The markers, known as haplotypes or Hap Markers, are akin to genomic bar codes and represent the pattern and organization of DNA variability inherited individually. Terms were not disclosed.
¿ Genmab A/S, of Copenhagen, Denmark, and Nottingham, England-based Scancell Ltd. will collaborate to develop fully human antibodies to cancer targets identified by Scancell. The first antibody product will target Lewis (y/b), a target overexpressed on breast, lung, colon and ovarian cancers. Under terms of the agreement, the companies will share development costs and commercialization rights of resulting antibody products.
¿ Maxygen Inc., of Redwood City, Calif., said it will take its Dengue vaccine into preclinical development. Maxygen said it has now fulfilled its goal of bringing two new therapeutics products into preclinical development in 2001. It has four products in its preclinical therapeutics pipeline overall.
¿ Karo Bio AB, of Huddinge, Sweden, reported mixed findings in studies designed to determine whether topical treatment with KB002611, a thyroid hormone analogue, has activity in human skin for the treatment of skin atrophy. One sought to determine if the drug could reverse the deleterious effects of skin-damaging agents such as potent topic corticosteroids. No apparent difference was detected between KB002611 treatment and that of a placebo in topical applications of the drug designed to measure skin thickness. In the other study, healthy volunteers initially were treated with potent topic corticosteroids before receiving one of three follow-up creams: high-dose KB002611, low-dose KB002611 and placebo. Results showed substantially better effects of KB002611 treatment compared to placebo, with low-dose preparations appearing most effective.
¿ LifeSpan BioSciences Inc., of Seattle, reported that Strasbourg, France-based Aventis Pharma became the sixth subscriber to LifeSpan¿s database on expression and localization of G protein-coupled receptors. The database provides information on all non-olfactory GPCRs for use in validating new gene targets for drug therapy. Under the contract, Aventis researchers will have access to proprietary GCPR expression studies that LifeSpan has conducted for Aventis.
¿ Matrix Pharmaceutical Inc., of Fremont, Calif., will submit an application to the European Medicines Evaluation Agency seeking approval of its IntraDose Injectable Gel by the end of the fourth quarter. The centralized application will be based on results of two randomized, placebo-controlled Phase III studies of patients with recurrent or refractory head and neck cancer. One of the IntraDose studies was conducted primarily in Europe.
¿ MediChem Life Sciences Inc., of Chicago, entered a two-year medicinal chemistry agreement with Peapack, N.J.-based Pharmacia Corp. MediChem will commit resources for drug discovery in collaboration with Pharmacia¿s in-house researchers. MediChem will be paid for its research, and also would receive royalties on resulting products it invents or co-invents.
¿ Molecular Staging Inc., of New Haven, Conn., received a Small Business Innovative Research grant to develop a method of detecting rare human papillomavirus (HPV) transformed cells using Rolling Circle Amplification Technology. The company received the grant to develop a method using RCAT to analyze cells within a cervical sample for the presence of HPV DNA.
¿ Myriad Genetics Inc., of Salt Lake City, discovered a drug target for the treatment of a broad range of cancers and initiated lead optimization with a series of compounds that selectively kill cancer cells. The target was discovered using Myriad¿s ProNet proteomics technology to investigate the protein interactions that lead to apoptosis. Myriad researchers found that MPI-176716 induces apoptosis in several cancers. The target of MPI-176716 is a protein that Myriad believes has not been explored previously for drug development, therefore representing a new approach to killing cancer cells. Its stock (NASDAQ:MYGN) rose $4.06, or 11.7 percent Tuesday, closing at $38.84.
¿ StemCells Inc., of Palo Alto, Calif., was awarded a four-year, $225,000-per-year grant from the National Institutes of Health for its liver stem cell program. This is the second grant for the program, which is focused on identifying human liver stem and progenitor cells to treat certain liver diseases.
¿ Nastech Pharmaceutical Co. Inc., of Hauppauge, N.Y., began enrollment in a Phase II trial to evaluate the efficacy and safety of a nasal formulation of morphine gluconate for the treatment of breakthrough pain in opioid-tolerant cancer patients. Twenty patients will receive the medication as part of the open-label, single-site study. In October 2000, the company reported results from a pilot Phase II trial in which the product was used to treat patients suffering from moderate to severe chronic pain, with episodes of breakthrough pain.
¿ National Institute of Allergy and Infectious Diseases researchers at the Dale and Betty Bumpers Vaccine Research Center (VRC) began a Phase I trial testing the first AIDS vaccine invented at the facility. The VRC, described as a cross between a biotechnology company and an academic organization, is the first National Institutes of Health facility dedicated to vaccine research and production. The vaccine was produced one year after the building housing the new center opened. It contains DNA blueprint for two pieces of HIV, labeled gag and pol. Gag is HIV¿s core protein, while pol includes three enzymes crucial to HIV replication. Together, they make up nearly half of HIV¿s total protein. The 21-person trial will assess safety and immune response.
¿ Nautilus Biotech, of Paris, reported the incorporation of Nautilus Biotech LLC in California. Part of the company will relocate to San Diego. Nautilus develops biopharmaceuticals, industrial proteins and protein reagents.
¿ Orphan Medical Inc., of Minneapolis, submitted a new drug application amendment to the FDA for its Xyrem oral solution. The amendment responds to the agency¿s approvable letter received in July for the product to treat cataplexy associated with narcolepsy. The amendment includes revisions to product labeling and the risk management program, a safety update on ongoing trials and respiratory data from narcolepsy patients in a trial completed earlier this year. (See BioWorld Today, July 5, 2001.)
¿ Protein Design Labs Inc., of Fremont, Calif., started a Phase II trial to evaluate its humanized antibody to interleukin-4 in asthma. The beginning of the trial triggered an undisclosed milestone payment to PDL from GlaxoSmithKline plc, of London. The study will be conducted in the United States in 120 symptomatic asthma patients who are not being treated with controller medications.
¿ Raven Biotechnologies Inc., of South San Francisco, and Cambridge, Mass.-based ImmunoGen Inc. said Raven delivered the first in a series of candidate monoclonal antibodies for evaluation by ImmunoGen. ImmunoGen gets development, manufacturing and commercialization rights in North America and Europe to therapeutic products stemming from the targets and antibodies provided by Raven through its technology. Raven as part of the deal was entitled to an up-front licensing fee, research support, milestones and royalties. (See BioWorld Today, March 30, 2001.)
¿ Senesco Technologies Inc., of New Brunswick, N.J., said its proprietary DHS and Factor-5A genes for regulating senescence have been isolated from mammalian tissue. The company said that previously the genes had only been found in plants. Senesco is a gene discovery company focused on enhancing the quality and productivity of fruits, flowers, vegetables and agronomic crops through the control of aging in plants.
¿ Texas Biotechnology Corp., of Houston, said marketing partner GlaxoSmithKline plc, of London, initiated a Phase II trial evaluating Argatroban as a treatment for patients undergoing percutaneous coronary interventions. The 100-patient, open-label trial is designed to test the drug¿s safety and efficacy as an alternative to heparin, an anticoagulant, and in combination with GPIIb/IIIa receptor antagonists. Argatroban is a synthetic direct thrombin inhibitor that blocks thrombin, which is widely known to play a role in forming clots. Results are expected in the first half of next year.
¿ Third Wave Technologies Inc., of Madison, Wis., lunched its first series of Invader RNA Assay products, a method for measuring gene expression levels. Invader products identify and quantify unique mRNAs directly from total RNA or crude cell samples called cell lysates. Thirty Invader products are included in the launch.
¿ Transgenomic Inc., of Seattle, reported that the Virginia Mason-Research Center has adopted Transgenomic¿s Wave System 3500HT for genetic analysis to identify mutations that cause breast cancer. Researchers at the center are participating in a study to identify mutations in the ATM gene that increase susceptibility to breast cancer.
¿ Tranzyme Inc., of Birmingham, Ala., and Cystic Fibrosis Foundation Therapeutics Inc., a non-profit affiliate of the Cystic Fibrosis Foundation, are partnering to develop novel cell lines to be used for cystic fibrosis drug discovery. Tranzyme will use its gene delivery and expression technologies to establish immortalized human bronchial epithelial cell lines derived from normal individuals and cystic fibrosis patients expressing varying levels of either mutant or wild-type cystic fibrosis transmembrane conductance regulator genes. Resulting cell lines will be available to the cystic fibrosis research community. Also, Tranzyme will have access to cell lines for use in its discovery programs. The CFFTI will provide Tranzyme R&D support, including funding for up to five scientists and technical personnel for a year. They will share future revenue from these cell lines.
¿ Unigene Laboratories Inc., of Fairfield, N.J., reported analysis of data from pivotal trials for its proprietary nasal calcitonin spray, showing a rapid and persistent reduction in bone loss as measured by several accepted blood markers. A substance in the bloodstream that measures the rate of bone loss in the tested subjects decreased by an average of 40 percent in the first month of the study, a reduction maintained during the ensuing two months of the three-month dosing period.