• AVI BioPharma Inc., of Portland, Ore., said preclinical data reported at the American College of Toxicology meeting in Washington indicate that its compound lowered cholesterol without significant toxicity. The studies evaluated Neugene antisense compound targeting HMG coenzyme-A reductase, a liver enzyme involved in the production of cholesterol. The data showed that Neugene reduced serum cholesterol in two separate studies by 45.6 percent and 43.7 percent, compared to controls, with minimal toxicity.

• Avigen Inc., of Alameda, Calif., filed an investigational new drug application with the FDA seeking clearance to begin clinical testing of AV201, its drug for advanced Parkinson's disease. Avigen's next step would be to present the protocol for its open-label, dose-escalation Phase I study of AV201 to the Institutional Review Board at the University of California at San Francisco, where Avigen plans to conduct the trial.

• Coremed Inc., of Lake Bluff, Ill., said preliminary animal data show that Alvair, its pulmonary-delivered insulin formulation, has equal efficacy as subcutaneous insulin injection. The company also said efficacy was achieved at subunit/kg doses with sustained, steady action over hours, and that Alvair's glucodynamic profile was uniform and predictable.

• Generex Biotechnology Corp., of Toronto, said it would begin studies in diabetic adolescents between 12 and 19 years old. The target population includes patients who fail oral hypoglycemic therapy as well as those on multiple daily injections. Oralin, which enables insulin to be delivered orally instead of by injection, will be introduced in the treatment plan as a replacement for subcutaneous injections.

• GenVec Inc., of Gaithersburg, Md., said it expanded its multiyear subcontract with the Vaccine Research Institute of the National Institutes of Health in Bethesda, Md. The subcontract, issued and managed by SAIC-Frederick Inc., increases the total three-year potential funding from $10 million to about $16 million. GenVec will oversee the production and manufacturing of vaccine candidates using its adenovector technology. GenVec said the agreement also strengthens its ongoing efforts to develop scalable production processes to support product commercialization.

• Genzyme Genetics, a unit of Genzyme Corp., of Cambridge, Mass., said it would present data at this week's American Society of Human Genetics meeting in Los Angeles from a series of prenatal and genetic screening studies. Among the findings, the company said demographic and cultural factors weigh more heavily in deciding whether to have an amniocentesis to test for Down syndrome than do numerical risk factors such as age. Also, the carrier rate for Fragile X syndrome, the leading cause of inherited mental retardation, supports consideration of widespread screening for all pregnant women, not only those with a family history of the disease. Also, the combination of enzyme and DNA analysis should become the preferred method in carrier testing for Tay Sachs disease.

• Geron Corp., of Menlo Park, Calif., said underwriters of its recent 5 million-share public offering fully exercised their overallotment option to purchase 750,000 shares, resulting in gross proceeds of $9 million. Last month, the company raised $60 million through the sale of 5 million common shares priced at $12 each. Geron is developing therapeutic and diagnostic products for cancer based on its telomerase technology and its cell-based therapeutics using its human embryonic stem cell technology. (See BioWorld Today, Oct. 30, 2003.)

• Hybridon Inc., of Cambridge, Mass., said data published in the Oct. 31, 2003, issue of Biochemical and Biophysical Research Communications illustrate an approach to the design of immunomodulatory oligonucleotide compounds that promote human B-cell proliferation as well as production of interferon-alpha from plasmacytoid dendritic cells.

The National Institutes of Health in Bethesda, Md., said a study funded by its National Institute of Arthritis and Musculoskeletal and Skin Diseases shows that lupus patients have antibodies in their blood for years before disease symptoms surface. The findings were discovered through the analysis of samples from 130 anonymous lupus patients who were once healthy but later developed the condition, compared to samples from people without the disease. The researchers also found that lupus autoantibodies tend to accumulate in blood in a predictable pattern until diagnosis, when the accumulation rate slows.

• OXIS International Inc., of Portland, Ore., said an article published by scientists from the Cleveland Clinic Foundation in the Oct. 23, 2003, issue of the New England Journal of Medicine reports that an assay the company developed enabled the prediction of early risk signs of cardiovascular diseases. A single oxidative-stress measurement of myeloperoxidase (MPO) levels in blood plasma, using the OXIS-MPO Assay, proved essential in predicting serious cardiac events, including myocardial infarction and death, in the 604 patients studied.

• Pain Therapeutics Inc., of South San Francisco, filed an investigational new drug application for Remoxy (formerly called PTI-821), a product designed to deter drug abusers from extracting oxycodone. The company said it expects to begin a Phase I/II pharmacokinetics study in the first quarter to evaluate the oral, long-acting oxycodone capsule, which is formulated in a sticky, high-viscosity capsule designed to make it difficult for drug abusers to inject or snort. It is formulated with technology developed by Durect Corp., of Cupertino, Calif.

• PharmaStem Therapeutics Inc., of Menlo Park, Calif., will receive more than $7 million after winning a patent infringement lawsuit in Delaware. A jury unanimously found that PharmaStem's umbilical cord stem cell patents were valid and enforceable. The judgment also ruled that the four defendants - ViaCell Inc., of Boston; Cryo-Cell International Inc., of Clearwater, Fla.; CorCell Inc., of Philadelphia; and CBR Systems Inc., of San Bruno, Calif. - infringed patents covering the technology for collecting, cryopreserving and storing stem cells derived from umbilical cord and placental blood for future therapeutic use.

• Shire Biologics, a unit of Shire Pharmaceuticals Group plc, of Andover, UK, said it would invest C$46.5 million (US$34.5 million) to expand its vaccine production facility in Quebec City. The growth stems from a July announcement that Shire was selected by the Canadian government to supply 75 percent of that country's influenza vaccine needs beginning with this year's flu season.

• Titan Pharmaceuticals Inc., of South San Francisco, was named as defendant in a class-action lawsuit filed in the U.S. District Court for the Northern District of California. The complaint alleges that during a period from Dec. 1, 1999, to July 22, 2002, the defendants boosted claims about their development program for the investigational schizophrenia drug Zomaril (Iloperidone). Last summer, the company disclosed that a cardiac safety study produced inconclusive data to support a filing. That news dropped the firm's stock value by nearly 60 percent to $1.63 on the day the news was released. About a year before that, the company's stock fell when it disclosed a delay in planned regulatory filing. At that time, the company and its partner, Novartis AG, of Basel, Switzerland, said they would begin additional dose-related trials of the schizophrenia drug. (See BioWorld Today, July 25, 2001, and July 23, 2002.)

The University of Michigan Comprehensive Cancer Center in Ann Arbor, Mich., and Baylor University Medical School in Houston, said their researchers have developed a target that could lead to a biological therapy for breast cancer. The findings were presented at the International Association for Breast Cancer Research meeting in Sacramento, Calif., sponsored by the University of California Davis Cancer Center. The scientists isolated human and mouse mammary stem cells that play a pivotal role in breast cancer, and later transplanted the cells into mice to produce breast tissue. They also isolated stem cells that keep their stem cell properties as well as transform into mature, multilineage cells. The experiments also showed that genes expressed by the stem cells are different from genes expressed by other cells and other cancer cells.

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