• Affymetrix Inc., of Santa Clara, Calif., reported the availability of the world's first microarray instrument system for clinical diagnostics. The GeneChip System 3000Dx is CE marked for in vitro diagnostic use, enabling clinical laboratories in Europe to analyze microarray diagnostics, such as the Roche AmpliChip CYP450 Test. The test, which looks for genetic variations that can affect drug efficacy and cause adverse drug reactions, is the first CE marked microarray product launched in the partnership between Roche Diagnostics, part of F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Affymetrix.

• Amylin Pharmaceuticals Inc., of San Diego, and Eli Lilly and Co., of Indianapolis, said the FDA accepted for review its new drug application for exenatide for Type II diabetes. The Prescription Drug User Fee Act goal date is April 30. The clinical component of the submission is based on 30-week data from three blinded pivotal trials of exenatide involving more than 1,400 patients who were unable to control their blood sugar on common oral therapies including metformin, sulfonylurea or a combination of both. The submission also includes 52-week, open-label data from the extensions of the pivotal studies and from an additional open-label study. The NDA was submitted two months ago. (See BioWorld Today, July 1, 2004.)

• Arriva Pharmaceuticals Inc., of Alameda, Calif., said data show that recombinant alpha-1-antitrypsin (rAAT) prevented up to 73 percent of the lung tissue breakdown caused by cigarette smoke in treated animals. Arriva will present data on rAAT at the European Respiratory Society Meeting in Glasgow, UK, next week. The data conducted in conjunction with the Brigham and Women's Hospital in Boston, and Washington University in St. Louis, suggest low levels of inhaled rAAT might modify the decline in lung function found in emphysema.

• Atrix Laboratories Inc., of Fort Collins, Colo., and its partner Fujisawa Healthcare Inc., of Deerfield, Ill., submitted a new drug application to the FDA for Aczone gel 5 percent (dapsone topical gel), formerly called Atrisone, to treat acne vulgaris. Aczone uses Atrix's Solvent Microparticle delivery system to deliver dapsone, which is only commercially available for other indications, as an oral tablet for systemic delivery due to its water insolubility.

• Australian Cancer Technology Ltd., of Sydney, Australia, raised about A$3.8 million (US$2.7 million) in gross proceeds through a placement of about 9.5 million ordinary shares at A40 cents apiece and about 1.7 million three-year options, exercisable at A60 cents per share. The company said the capital would allow it to continue its overseas expansion into the U.S. and European markets, and also to further develop its anti-idiotypic cancer vaccine, Pentrys. More than 60 percent of the shares were placed with Mercury Investments Ltd., and the remaining shares were underwritten by Jaguar Advisory Services Pty. Ltd. The options have been allocated between Mercury and Jaguar in the amount of 1 million and 653,880, respectively. The shares were placed through Jaguar and Hunting Party Securities Ltd.

• Bolder BioTechnology Inc., of Wheat Ridge, Colo., was awarded two Small Business Innovation Research grants from the National Cancer Institute of the National Institutes of Health in Bethesda, Md. The first, a Phase II award worth $819,961, is titled "Long Acting Endostatin for Treating Cancer." The second, a Phase I grant worth $100,000, is titled "Long Acting VEGF Binding Proteins for Treating Cancer." The company said the funds would allow it to expand its anti-angiogenesis research efforts and be used to optimize two human proteins with anti-angiogenesis properties and measure efficacy of the modified proteins in preclinical cancer models.

• CancerVax Corp., of Carlsbad, Calif., said data in the September 2004 issue of the Federation of American Societies for Experimental Biology Journal show that an 11-nucleotide T-oligo (telomere homologue oligonucleotide) inhibited melanoma tumor growth and reduced the size and number of metastases in preclinical studies. Results also showed in vitro treatment induced apoptosis of melanoma cells but not of normal human melanocytes. The data support previous findings indicating that T-oligos might activate natural defense mechanisms to induce cell-cycle arrest, differentiation or apoptosis in cancerous cells. The T-oligo technology is a component of CancerVax's pipeline, which includes Canvaxin SAI-EGF.

• Cellegy Pharmaceuticals Inc., of South San Francisco, said the FDA accepted for review its new drug application for Cellegesic (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. The agency established May 1 as the outside date for a decision on approvability of the product, the company said, adding that scheduling of clinical site audits by the FDA is under way. The filing was based, in part, on three Phase III trials that showed that Cellegesic provides a statistically and clinically significant reduction in the pain associated with chronic anal fissures. The last of the three was conducted under the provisions of a special protocol assessment. Cellegy submitted the NDA two months ago. (See BioWorld Today, July 1, 2004.)

• Chiron Corp., of Emeryville, Calif., and Gen-Probe Inc., of San Diego, reported that testing with the Procleix West Nile Virus (WNV) Assay was initiated under an investigational protocol on the Procleix Tigris System, a high-throughput, fully automated nucleic acid-testing system developed by Gen-Probe. The Procleix WNV Assay has detected 137 WNV-infected donations since May, the companies said.

The Fred Hutchinson Cancer Research Center in Seattle said its researchers published data in the Sept. 1, 2004, issue of Cancer Research showing that when mice are engineered to lose a single copy of a gene called Rb in their prostate, they develop a precancerous condition analogous to the earliest stages of human prostate cancer. In the absence of additional genetic defects, the mice do not develop full-blown prostate cancer. That suggests that the loss of Rb in prostate cells could be the initial spark that in some men eventually leads to prostate cancer, the researchers said.

• Genmab A/S, of Copenhagen, Denmark, said Phase II data of HuMax-CD4 in cutaneous T-cell lymphoma (CTCL) showed patients had an average response duration of more than 6.6 months. The duration is based on an analysis of responding mycosis fungoides (MF) patients at all dose levels tested. Median time to disease progression of all 38 MF patients in the two Phase II studies is more than 5.7 months. HuMax-CD4 is a high-affinity human antibody that targets the CD4 receptor on T lymphocytes. MF is the most common form of CTCL.

• GenVec Inc., of Gaithersburg, Md., entered a Specific Cooperative Agreement with the Agricultural Research Service (ARS) of the U.S. Department of Agriculture to conduct research to prevent the spread of foot and mouth disease. Under the terms of the 12-month, $300,000 agreement, funded in part by the Department of Homeland Security, GenVec will use its adenovector technology to deliver antiviral compounds previously shown by ARS to stimulate the immune system in livestock and protect the animals against the disease.

• GPC Biotech AG, of Martinsried, Germany, said it opened enrollment for a Phase I/II study of satraplatin and simultaneous radiation therapy in patients with locally advanced non-small-cell lung cancer. The Phase I portion is expected to enroll up to 30 patients and will determine dose-limiting toxicities, maximum tolerated doses and recommended Phase II doses. The Phase II portion will evaluate the safety and efficacy of the combination therapy at the selected doses. Satraplatin is a platinum-based oral drug that is given as a capsule. Satraplatin also is in a Phase III trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer. GPC is co-developing satraplatin with Spectrum Pharmaceuticals Inc., of Irvine, Calif.

• Guilford Pharmaceuticals Inc., of Baltimore, reported that Craig Smith will retire as chairman, president and CEO. The board has begun a search for a successor. Smith will remain as chairman, president and CEO until the company's next annual meeting, unless a successor is identified earlier. After retirement, Smith will continue as a board member and will serve as a consultant to the company for at least one year.

• Helix BioPharma Corp., of Aurora, Ontario, raised about C$4.5 million (US$3.4 million) through a private placement of about 2.1 million common shares and an equal number of common share purchase warrants. Each warrant entitles the holder to purchase one common share at a price of C$3 until March 1, 2007. The cancer therapy company said it plans to use the proceeds to fund development of products in its pipeline, as well as for working capital and general corporate purposes. The transaction included a group of Canadian investors, including Sherfam Inc., the holding company for the Apotex Group of companies.

• Scios Inc., of Fremont, Calif., said the Sept. 1, 2004, issue of The American Journal of Cardiology details the results of the FUSION I (Follow Up Serial Infusions Of Natrecor) study, a controlled study of outpatient intravenous infusion therapy conducted in heart failure patients.

• Shiprock Inc., of Philadelphia, completed its acquisition of privately held Duska Scientific Co., of Bala Cynwyd, Pa. As a result, Shiprock changed its name to Duska Therapeutics Inc. and will continue to trade on the Over-the-Counter Bulletin Board under the trading symbol "DSKT." Duska is developing diagnostic and therapeutic products based on technology related to adenosine 5'-triphosphate (ATP) and ATP's receptors. The company owns or has exclusive license rights to four diagnostic and therapeutic applications that it said are in various stages of development.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said it would defend itself in a patent suit brought by Applied Research Systems ARS Holding NV, a wholly owned subsidiary of Serono International SA, of Geneva. In the amended complaint, which was filed in the U.S. District Court of Massachusetts, Serono alleges that by making, using, selling and/or offering for sale the methods, cell lines and/or DNA constructs claimed therein, TKT infringes Serono's U.S. Patent No. 5,272,071 that purportedly covers certain methods of gene activation. In the original complaint, Serono appealed a U.S. Patent and Trademark Office decision that 34 of the claims of the patent are, in Serono's words, unpatentable.

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