¿ Active Biotech AB, of Lund, Sweden, said its application to begin a Phase II trial of Tumour Targeted Superantigens (TTS) was approved by UK authorities. Treatment of patients with renal cell cancer will be started by December, the company said, and up to 45 patients will be included. The trial will run 12 months. TTS consists of an antibody combining with a toxin and stimulates the immune system to specifically and locally attack tumor cells.
¿ Aegis Analytical Corp., of Lafayette, Colo., closed its second round of financing, raising $14.5 million. The round was led by Merck Capital Ventures LLC, a subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J. Aegis is a provider of manufacturing informatics software systems for pharmaceutical, biotechnology, food, natural products, specialty chemical and medical device manufacturers.
¿ Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said positive results from its pilot Phase II study of Paxceed to treat severe psoriasis has led to a study extension. The five patients treated with monthly intravenous infusions over six months all exhibited a 50 percent to 75 percent improvement in their disease severity, the company said. Up to 13 additional patients now may be enrolled in the study. Paxceed is Angiotech¿s systemic formulation of micellar paclitaxel.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., submitted an investigational new drug application to the FDA to test a low-dose oral interferon-alpha product for the treatment of oral warts caused by human papillomavirus in HIV-infected patients. The company said it expects to move the product into Phase I trials in the next several months. Low-dose oral interferon-alpha is administered as a lozenge that is allowed to dissolve in the mouth.
¿ Avanir Pharmaceuticals Inc., of San Diego, said company scientists identified a small molecule found to be effective in suppressing the synthesis of immunoglobulin epsilon (IgE) and other critical mediators of the allergic response. IgE is considered to be the underlying cause of allergy and asthma symptoms. As a result of these findings, Avanir is seeking to develop an oral formulation that is intended to significantly prevent or reduce the signs and symptoms of allergy and asthma. Data on this new chemical entity, AVP-893, were presented at the American College of Allergy, Asthma and Immunology conference in Orlando, Fla.
¿ Celera Genomics Group, of Rockville, Md., said Otsuka Pharmaceutical Co., part of the Otsuka Group headquartered in Tokyo, signed a multiyear subscription agreement with Celera. Otsuka researchers will access the Celera Discovery System to use Celera¿s database products, bioinformatics systems and other discovery tools in their research. Financial terms of the agreement were not disclosed.
¿ CV Therapeutics Inc., of Palo Alto, Calif., said that in an open-label, dose-ranging Phase II trial in patients with atrial fibrillation or flutter, CVT-510 consistently reduced heart rate from baseline (p<0.05) without decreasing blood pressure. The company will begin a Phase IIb development program aimed at defining an optimized dosage regimen in patients with this disease. Current clinical trials for CVT-510 include a Phase III trial in patients with paroxysmal supraventricular tachycardia and Phase II trials in patients with atrial fibrillation.
¿ Diversa Corp., of San Diego, and The Dow Chemical Co., of Midland, Mich., said they have expanded their agreement to identify biocatalytic processes to replace multistep chemical synthesis. Also, the companies said several chiral pharmaceutical intermediate product candidates were identified and two are now in process development. The collaboration combines Dow¿s large-scale chemistry capabilities with Diversa¿s enzyme discovery and optimization technology. Financial details were not disclosed.
¿ Geron Corp., of Menlo Park, Calif., said it saw positive results from in vivo studies conducted with its anticancer compound, GRN163, on human brain tumors in a mouse model. Results were presented Saturday at the Society of Neuro-Oncology meeting in Washington. GRN163 is a modified oligonucleotide compound that acts as a telomerase template antagonist.
¿ HMSR Inc., of Marlborough, Mass., signed a definitive agreement to merge with Point Therapeutics Inc., of Boston. Each outstanding share of Point Therapeutics¿ common stock will be converted into the right to receive about 37.4 shares of common stock of HMSR. Following the merger, the ownership of HMSR¿s current stockholders and Point Therapeutics¿ current stockholders in HMSR is expected to be about 23 percent and 77 percent, respectively, although that is subject to downward adjustment for HMSR to the extent that HMSR¿s cash and cash equivalents balances at closing are less than $16.5 million. The transaction is expected to close in the first quarter of 2002. Point Therapeutics will become a wholly owned subsidiary of HMSR, which will remain a public company. HMSR, formerly HemaSure Inc., sold substantially all of its noncash assets, including its name, to Whatman plc, of London, in May.
¿ Immuno-Designed Molecules SA, of Paris, said IDM-activated macrophage cells significantly reduced tumor recurrence in a Phase I/II clinical trial in superficial bladder cancer. Results of a two-year follow-up were presented at the ¿European Perspectives on Bladder Cancer¿ conference in Monte Carlo. Preliminary data indicate that MAK therapy is well tolerated and safe. Also, MAK therapy appears to have reduced the frequency of disease recurrence the first year after treatment.
¿ Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said its prototype catalytic antioxidant, AEOL 10113, was shown to significantly delay onset of elevated blood sugar in a mouse adoptive transfer model of Type I diabetes. Administration of AEOL 10113 protected mice treated with cloned, diabetes-producing (BCD-2.5) T cells from developing diabetes as compared to control. The data were presented at the 2001 annual meeting of the Oxygen Society in Research Triangle Park.
¿ Infigen Inc., of DeForest, Wis., completed a clone of the renowned Canadian Holstein cow Crescentmead-A Margo, VG-86-4y. The Infigen clone, ¿Margo II,¿ is the oldest adult bovine clone in Canada since going home in October to Ganaraska Holsteins in Ontario. Margo II calved Sept. 25 and is now milking over 100 pounds per day.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated clinical testing of Isis 104838, an antisense inhibitor of tumor necrosis factor-alpha (TNF-alpha) in rheumatoid arthritis. This Phase II clinical trial will evaluate the ability of Isis 104838 to reduce the level of TNF-alpha in synovial tissue, the autoimmune target tissue involved in rheumatoid arthritis, and in blood. The study also will evaluate the biological effect of TNF-alpha inhibition by Isis 104838 in rheumatoid arthritis.
¿ Medarex Inc., of Princeton, N.J., and Ambit Biosciences Corp., of San Diego, formed a multiyear collaboration to use Medarex¿s UltiMAb Human Antibody Development System and Ambit¿s ProteomeScan screening technology to develop and commercialize monoclonal antibody therapeutic products. The companies will share equally the costs and revenues of any products. Medarex made a $1 million equity investment in Ambit associated with the collaboration.
¿ MetaPhore Pharmaceuticals Inc., of St. Louis, said the National Institutes of Health awarded it a six-month, $261,000 Small Business Innovation Research grant to study a potential new therapy for ischemic heart disease. The grant will help fund further preclinical studies with MetaPhore¿s family of superoxide dismutase mimetics. The funding is the fourth grant the company has received to date.
¿ MorphoGen Pharmaceuticals Inc., of San Diego, closed its Series C preferred stock offering, generating up to $8.5 million in proceeds. The stock was purchased by a syndicate of investors led by AIG Global Investment Corp. and includes Manulife Capital Corp. and Wheatley Medtech Partners. The company received its seed funding in August 2000. (See BioWorld Today, Aug. 28, 2000.)
¿ NeoPharm Inc., of Lake Forest, Ill., released preliminary Phase I/II safety and efficacy results for its novel tumor-targeting agent, IL13-PE38, in the treatment of malignant glioma, a fatal form of brain cancer for which there is no known cure. IL13-PE38 recently was granted orphan drug designation by the FDA. The data indicate that IL13-PE38 may be effective, safe and effectively administered by positive-pressure microinfusion. Fourteen patients have been enrolled in one study by the New Approaches to Brain Tumor Therapy CNS Consortium, and enrollment continues. Noticeable response to IL13-PE38 was observed in two of six patients. A second dose-escalation study is being conducted to determine the histologically effective concentration of IL13-PE38 to establish evidence of its ability to kill tumors.
¿ Novogen Ltd., of Sydney, Australia, said the FDA advised that a clinical trial be expedited at the Cleveland Clinic on Novogen¿s anticancer product, phenoxodiol, a small-molecule signal transduction inhibitor. As a result of the decision, phenoxodiol can be administered to U.S. cancer patients in higher doses sooner than would otherwise have been scheduled under the previous protocol. Phenoxodiol is in Phase Ib/IIa trials in the United States and Australia. Novogen¿s stock (NASDAQ:NVGN) rose $1.08 Monday, or about 30 percent, to close at $4.58.
¿ Paradigm Genetics Inc., of Research Triangle Park, N.C., and StemCo BioMedical Inc., also of Research Triangle Park, entered a research collaboration for the biochemical profiling of adult human stem cells. Paradigm will use its metabolomics technology platform, MetaVantage, to elucidate the biochemical profiles of adult stem cells supplied by StemCo, and will use the generated biochemical profiles to identify all of the small molecules present in the cells. Paradigm will retain all intellectual property rights to any discoveries related to the biochemical profiles and the compounds themselves. StemCo will retain rights related to the studied stem cells themselves for diagnostic or therapeutic purposes. Financial details were not disclosed.
¿ Peregrine Pharmaceuticals Inc., of Tustin, Calif., closed an offering for $5.75 million off of the shelf registration Form S-3 it filed with the Securities and Exchange Commission. The shares of common stock were sold to six institutional investors, including a director of the company. Peregrine now has about $11.6 million in cash to fund its clinical trials, contract manufacturing operations and research and development. The company will use the money to fund its planned Phase III brain cancer trial expected to begin later this year pending FDA approval. Zimmer Lucas Partners LLP, of New York, led the offering.
¿ Ricerca LLC, of Concord, Ohio, said an active pharmaceutical ingredient manufacturing agreement between Alteon Inc., of Ramsey, N.J., and Chemi S.p.A., of Milan, Italy, was signed. The agreement was arranged through the Ricerca-Chemi custom pharmaceutical manufacturing alliance previously established. Chemi will perform process validation, cGMP production of late-stage clinical batches and commercial manufacturing of Alteon¿s Advanced Glycosylation End-products crosslink breaker, ATL-711, a drug for the treatment of systolic hypertension. Financial details were not disclosed.
¿ Sosei Co. Ltd., of Tokyo, initiated a Phase I trial of DRP-001 in the United Kingdom. DRP-001 is the first demonstration of Sosei¿s Drug-Re-profiling Programme. The company said it is planning to develop the product for the treatment of stress and mixed-type urinary incontinence.
¿ Stressgen Biotechnologies Corp., of Victoria, British Columbia, initiated a Phase II open-label trial in pediatric patients suffering from a human papillomavirus-related disease called recurrent respiratory papillomatosis. Stressgen was granted orphan drug status for HspE7, a novel immunotherapeutic, from the FDA in March of this year. The trial will involve about 27 pediatric patients who require frequent surgery, and it will be conducted in multiple centers in the United States. The endpoint for the trial will be an increased interval between clinically required surgeries, and data could be available as early as 2002.