• Applied Biosystems, of Foster City, Calif., released the Human Genome Survey Microarray V2.0 for use with the Applied Biosystems Expression Array System, a component of Applied Biosystems' solution for gene-expression analysis that is designed to allow researchers to move from whole-genome analysis to single-gene validation.

• ArQule Inc., of Woburn, Mass., enrolled its first patient in a Phase Ib/II combination trial of ARQ 501 and gemcitabine. The Phase I component is an open-label, dose-escalation study, enrolling patients with advanced cancer, some of whom might previously have received gemcitabine. ArQule anticipates that the component will be followed by a Phase II study exploring the use of ARQ 501 and gemcitabine in patients with advanced cancer.

• AspenBio Inc., of Castle Rock, Colo., said its board appointed Richard Donnelly president and CEO. Donnelly has held management roles at animal health companies including Heska Corp., the Fort Dodge Division of American Home Products and the Janssen Pharmaceutica division of Johnson & Johnson. AspenBio was founded in 2000 to acquire the antigen business of Vitro Diagnostics Inc.

• CytoGenix Inc., of Houston, participated in a teleconference with members of the FDA's Center for Biologics Evaluation and Research concerning the company's CY301 herpes topical agent investigational new drug application. In preparation for the IND filing later this year, members from the CBER Division of Cellular and Gene Therapies provided comments, guidance and clarification about preclinical requirements for CY301.

• DOR BioPharma Inc., of Miami, received notice that the American Stock Exchange accepted its compliance plan, submitted on Dec. 30. The company has been granted an extension until July 12, 2005, to regain compliance. The standard requires that member companies that have incurred losses in three of their last four years must maintain a shareholder equity balance of at least $6 million. The company is developing biodefense vaccines and therapeutics for areas of unmet medical needs.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., expanded its ability to provide genetic tests for critical variants of key cardiac ion channel proteins involved in drug-induced cardiac arrythmias. Drug-induced cardiac arrythmias that are associated with prolongation of the QT interval on the electrocardiogram have led to the withdrawal from the market of certain drugs. Vanderbilt University granted Genaissance exclusive commercial rights to U.S. Patent 6,458,542.

• GenData Research Corp., of Salt Lake City, is changing its name to LineaGen Research Corp. LineaGen uses a population genetics discovery platform to identify and validate biomarkers, coordinate clinical trials and identify health-promoting and disease-causing genetic factors.

• Genetronics Biomedical Corp., of San Diego, is acquiring Inovio AS, of Oslo, Norway. Genetronics said that Inovio's use of electroporation for gene therapy and DNA vaccines is a complement to Genetronics' existing electroporation-therapy program. The deal includes cash in Inovio's treasury of about $775,000 and about $2 million in current and anticipated appropriations for biodefense research from the U.S. Army and other committed grants. The share-purchase agreement consists of $3 million in cash, $7 million in Genetronics stock and potential additional share payments given the achievement of certain revenue milestones.

• GlycoGenesys Inc., of Boston, added a new indication, chronic lymphocytic leukemia (CLL), to its cancer clinical trial program for GCS-100LE. With the addition, GlycoGenesys could pursue approvals in two indications in cancer and start the international clinical and regulatory program for GCS-100LE. The company expects to initiate a Phase I/II study in CLL in both the U.S. and the UK in the first half of this year.

• Helix BioPharma Corp., of Aurora, Ontario, signed an exclusive agreement to license its Biochip technology to Bothell, Wash.-based Lumera Corp. Lumera is expected to use the technology to produce protein chip sets for the protein array market. The license agreement calls for both up-front and milestone payments to Helix, in addition to future royalty payments. A portion of the Biochip technology was licensed by Helix from Edmonton, Alberta-based Pence Inc., the University of Alberta and McGill University in Montreal, which also are entitled to share in the revenue. Helix retains the right to use the Biochip technology for its own research activities.

• ID Biomedical Corp., of Vancouver, British Columbia, completed its final analysis of immune responses of adults in its Phase II trial of StreptAvax vaccine, its subunit protein-based vaccine against Group A streptococcal diseases. The trial enrolled 90 healthy adult subjects, 70 of whom received StreptAvax and 20 of whom received hepatitis A vaccine. StreptAvax is designed to induce protective immune responses to 26 different M protein serotypes of Group A streptococci. Data showed that, among other things, in the 70 subjects who received StreptAvax there was a statistically significant (p<0.0001) increase in serum antibodies to all 26 M protein serotypes, and to the Spa protein.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, said it is listed on the Nasdaq Over-the-Counter Bulletin Board under the symbol "IXSBF." The company is developing monoclonal antibodies with its SuperAntibody Technology Platform.

• Isotechnika Inc., of Edmonton, Alberta, completed recruitment for its Canadian Phase III psoriasis trial of ISA247, an immunosuppressive compound. Of the 400 patients enrolled, the company said 207 already have begun treatment. The study's primary endpoint is a measure of the proportion of subjects who achieve a 75 percent reduction in their Psoriasis Area and Severity Index score, and secondary endpoints include maintenance of stable kidney function and assessment of quality of life. Isotechnika said it expects results of the trial to be available by late summer. (See BioWorld Today, Dec. 3, 2004.)

• ISTA Pharmaceuticals Inc., of Irvine, Calif., announced the closing of its public offering of common stock and said the company expects to realize net proceeds of $52 million. ISTA issued and sold about 6.3 million shares, including the overallotment option, at a price of $8.88 each. The company plans to use the funds to finance potential acquisitions and license complementary businesses, assets, technologies and products. ISTA announced the financing last week. (See BioWorld Today, Jan. 24, 2005.)

• Marshall Edwards Inc., of Washington, said the FDA granted fast-track status for its investigational cancer drug, phenoxodiol, to treat patients with hormone-refractory prostate cancer. The company's application was based on data from a monotherapy Phase Ib/IIa study, in which men with late-stage HRPC were treated with an oral dose of phenoxodiol. Results indicated that dosages of phenoxodiol ranging from 200 mg to 400 mg every eight hours had a significant effect on disease progression, according to falls in PSA levels and suppression of those levels for at least six months.

• Martek Biosciences Corp., of Columbia, Md., said it received net proceeds of $81.4 million after closing its sale of 1.76 million shares of common stock at a price of $49.10 per share. The sale included 1.5 million shares and the underwriters' option to purchase 229,124 additional shares to cover overallotments. Martek said it will use the proceeds for capital expenditures, working capital and general corporate purposes.

• MorphoSys AG, of Martinsried, Germany, expanded its existing license agreement with Bristol-Myers Squibb Co., of New York. MorphoSys granted BMS access to its HuCAL Gold library for use in discovery programs for target characterization and validation, as well as for therapeutic and diagnostic antibody product development. Financial details were not disclosed.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said that its partner, Merck & Co. Inc., of Whitehouse Station, N.J., initiated a Phase I study for PYY3-36 nasal spray for the treatment of obesity. Nastech and Merck will jointly develop PYY. Merck will assume primary responsibility for clinical and nonclinical studies and regulatory approval, while Nastech will be responsible for all manufacturing of PYY-related product. Merck will lead and fund commercialization, with Nastech having an option to co-promote the product in the U.S. PYY3-36 is designed to deliver the hormone PYY directly to the bloodstream.

• Palatin Technologies Inc., of Cranbury, N.J., said that the Committee for Medicare and Medicaid Services established a temporary Healthcare Common Procedure Coding System reimbursement code for the payment of NeutroSpec. The reimbursement code allows Medicare reimbursement for infection imaging in an outpatient setting. NeutroSpec is Palatin's radiolabeled monoclonal antibody product for imaging and diagnosing infections.

• Pozen Inc., of Chapel Hill, N.C., received a letter agreeing to recommend marketing authorization for its MT 100 from the Committee on Safety of Medicines, the advisory group to the UK's Medicines and Healthcare Products Regulatory Agency. Pozen said it will provide additional information required and meet conditions outlined in the letter. If UK approval is granted by MHRA, the company will seek to market MT 100 in Denmark, Sweden, Norway and Finland through the mutual recognition procedure. Last summer, Pozen received a not approvable letter from the FDA for MT 100, a combination of naproxen and metoclopramide designed to treat migraines. (See BioWorld Today, July 16, 2004.)

• Resverlogix Corp., of Calgary, Alberta, formed an international research collaboration with atherosclerosis researcher Prediman Shaw, director of the division of cardiology and the Atherosclerosis Research Center at Cedars-Sinai Medical Center in Los Angeles. Resverlogix said the agreement will advance its Nexvas technology program, which develops therapies to increase high-density lipoprotein to treat cardiovascular diseases.

• Viventia Biotech Inc., of Toronto, completed enrollment in its second Phase I study of Proxinium in advanced, recurrent head and neck cancer. The study enrolled 20 patients. Interim results are expected to be released by the end of the quarter, and full data are expected at the American Society of Clinical Oncology meeting in May.

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