• Access Pharmaceuticals Inc., of Dallas, said results from the Phase I trial of AP5346, a Dach platinum polymer therapeutic, showed that of 19 patients, seven were not evaluable for tumor response, principally due to withdrawal from the study prior to completing the required cycle. Of the 12 evaluable patients, two exhibited a response - one demonstrated a partial response and one experienced stable disease. The patient responding was a melanoma patient with a lung metastasis, in which a CT scan revealed a tumor decrease of greater than 50 percent.

• Active Pass Pharmaceuticals Inc., of Vancouver, British Columbia, received a grant of C$3.6 million (US$2.8 million) for development of a treatment for secretory diarrhea from the National Institute of Allergy and Infectious Diseases. Active Pass is focused on exploiting the ABC transporter gene family as pharmacological targets. The secretory diarrhea technology is based on inhibition of an ABC transporter called CFTR.

• Adventrx Pharmaceuticals Inc., of San Diego, said preclinical studies demonstrated enhanced antitumor activity with lower systemic toxicity in a mouse model for colorectal cancer using CoFactor, as compared to leucovorin, in combination with the chemotherapeutic agent 5-fluorouracil. CoFactor is in Phase II trials in the U.S. and Europe for metastatic colorectal cancer. Results were presented at the 16th annual EORTC-NCI-AACR symposium in Geneva.

• Amarin Corp. plc, of London, said that Thomas Lynch, its nonexecutive chairman, signed an agreement to buy the following securities in Amarin from Elan Corp. plc, of Dublin, Ireland, and its subsidiaries: about 4 million American depository shares representing about a 26 percent shareholding on an undiluted basis; warrants to subscribe for 500,000 Amarin ordinary shares at an exercise price of $1.90 per share; and $5 million in principal amount of Amarin secured 8 percent loan note, issued pursuant to a loan note instrument dated Feb. 25. Lynch agreed to convert $3 million of the loan note into Amarin ordinary shares, with an option to convert the remaining $2 million at the offering price of any future equity financing.

• Biota Holdings Ltd., of Melbourne, Australia, said the National Institute of Allergy and Infectious Diseases in Bethesda, Md., awarded Biota a $5.6 million grant to develop a new influenza drug as part of its pandemic preparedness strategy and Biodefense Research Program. Biota, in collaboration with Sankyo Co. Ltd., of Tokyo, is developing a second generation of flu drugs that have the potential to be administered once weekly.

• Chiron Corp., of Emeryville, Calif., granted a nonexclusive license to the Blood Transfusion Centers of the German Red Cross (DRK) for use of its HIV-1 and hepatitis C virus technology in molecular probe blood screening. Financial terms of the agreement were not disclosed. Chiron granted a license to DRK through 2008. In addition, DRK has the option to license Chiron's patents beyond 2008 upon payment of an additional fee.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., filed a complaint for patent infringement against Miami-based Ivax Pharmaceuticals Inc. and CorePharma LLC in the U.S. District Court for the Eastern District of New York. CollaGenex alleges that the defendants' submission of abbreviated new drug applications covering their 20-mg tablets of doxycycline hyclate (Periostat) infringe U.S. Patent No. 34,656, of which CollaGenex is the exclusive licensee. CollaGenex is seeking an injunction preventing Ivax and CorePharma from introducing the tablets into the U.S. market.

• Cosmo Bio Co. Ltd., of Tokyo, launched its new U.S. subsidiary, Cosmo Bio USA, in West Carlsbad, Calif. Cosmo Bio USA will offer its customers more than 2,000 products and services, including its Bioruptor multi-sample cell disruptor, I-MyRun HTS agarose gel electrophoresis system and a range of Japanese-made antibodies and reagents.

• Enhance Biotech Inc., of New York, began recruiting for a dose-ranging trial in preparation for Phase III of its premature ejaculation compound LI301. The trial is designed to evaluate the efficacy of three doses of LI301 on the Intravaginal Ejaculation Latency Time in subjects with premature ejaculation. The study will be conducted in Europe and will involve more than 80 couples. Results are expected in the second quarter of 2005.

• Exelixis Inc., of South San Francisco, released data for two of its receptor tyrosine kinase inhibitors in clinical development. The data reveal that both XL647 and XL999 have promise in the treatment of various forms of cancer through selective inhibition of RTKs. The data were presented at the 16th EORTC-NCI-AACR meeting in Geneva.

• GenVec Inc., of Gaithersburg, Md., said interim results from a Phase II study of TNFerade in esophageal cancer patients showed administration of the therapy with chemoradiation was feasible and well tolerated, with 82 percent of patients receiving all scheduled injections. The results were presented at the 16th EORTC-NCI-AACR conference in Geneva.

• Hana Biosciences Inc., of South San Francisco, formerly Email Real Estate.com Inc., said its shareholders approved a proposal to reincorporate from Colorado to Delaware law and change its name to Hana. The reincorporation became effective at the close of business on Sept. 30 and was accomplished by merging the company into Hana, its wholly owned subsidiary and a Delaware corporation. Effective Oct. 1, the company will trade on the Over-the-Counter Bulletin Board as "HNAB." Hana acquires, develops and commercializes products for cancer and immunological diseases.

• Hemagen Diagnostics Inc., of Columbia, Md., extended its offer to exchange about $6 million of its 8 percent senior subordinated secured convertible notes due 2005 for common stock and modified notes. The new expiration date is midnight on Oct. 15. To date, $4.8 million of the notes have been deposited for exchange. Hemagen develops, manufactures and markets medical diagnostic test kits for the diagnosis of certain autoimmune and infectious diseases.

• Human Genome Sciences Inc., of Rockville, Md., presented at 16th EORTC-NCI-AACR meeting in Geneva the results of preclinical studies of HGS-ETR1, HGS-ETR2, HGS-TR2J and the TRAIL death receptors, TRAIL-R1 and TRAIL-R2. Data presented included HGS-ETR1 results, which showed that of 134 malignancies evaluated, a total of 87 tumors, or 65 percent, showed some degree of TRAIL-R1 specific staining.

• ID Biomedical Corp., of Vancouver, British Columbia, was awarded up to $5.6 million by the National Institutes of Health in Bethesda, Md., to develop a nasally administered subunit vaccine to protect again severe acute respiratory syndrome. The primary aim of the work will be to test various formulations of vaccine candidates based on the company's Proteosome mucosal adjuvant/deliver technology.

• Immunomedics Inc., of Morris Plains, N.J., reported that its therapeutic product candidates, as well as those of its subsidiary, IBC Pharmaceuticals Inc., were the subject of five presentations made at the 16th EORTC-NCI-AACR meeting in Geneva. Three of the presentations involved the humanized anti-CD74 monoclonal antibody conjugated with the cancer drug doxorubicin.

• Maxim Pharmaceuticals Inc., of San Diego, reported that MX2167, a cancer agent discovered by its research team, targets the transferrin receptor leading to a previously unknown induction of apoptosis in preclinical tumor models. The transferrin receptor is located on the surface of cells and is overexpressed in several types of cancer.

• MethylGene Inc., of Montreal, disclosed cancer research data for two clinical programs, MGCD0103 and MG98, in three poster sessions which were presented at the 16th EORTC-NCI-AACR meeting in Geneva. Data demonstrate that MGCD0103 has antitumor activity in vivo in various xenograft models in mice, is orally active and appears to have a favorable therapeutic profile compared to some other HDAC inhibitors. Data shown for MG98, a DNA methylation inhibitor, describe preliminary results from an ongoing solid-tumor Phase I study showing that treatment with MG98 can lower DNMT1k mRNA levels 52 percent after cycle one and 65 percent after cycle two. A third poster of a study analyzing the mechanism of MG98 demonstrated that DNA methylation inhibitors such as MG98 can re-sensitize renal cancer cell lines to interferon-induced apoptosis.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., filed a universal shelf registration statement with the SEC, pursuant to which Nastech might issue common stock, warrants and debt securities from time to time, up to an aggregate of $80 million. The terms of any future offering would be established at the time of the offering, the company said. Nastech is dedicated to the development and commercialization of drug delivery technologies and products.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said its NXC-4720 product for the treatment of E. coli O157:H7 contamination for applications beyond treatment of meat at the processing stage. E. coli O157 bacteria not only can contaminate meat products such as ground beef but also public water supplies that can become contaminated from run-off from cattle farming operations where there are cattle harboring the bacteria.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., said data presented at the 42nd annual meeting of the Infectious Diseases Society of America showed that two Phase III trials of once-daily Factive tablets met the primary endpoints in the treatment of acute bacterial rhinosinusitis, including infection due to penicillin-resistant S. pneumoniae. Researchers saw an 87.3 percent and 86.9 percent improvement or resolution of signs and symptoms for the five-day and the seven-day dosages, respectively. In another study, researchers found a 90.3 percent eradication or presumed eradication of all initial pathogens without new infections. Factive is approved by the FDA to treat acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity.

• Rexahn Corp., of Rockville, Md., said its RX-0201 trial program in advanced or metastasized cancers is under way at the Georgetown University Hospital Lombardi Cancer Center in Washington. RX-0201 is a first-in-class signal inhibitor that directly blocks the production of Akt, a protein kinase playing a key role in cancer progression. Doses of the drug will be administered intravenously for 14 days. The trial will evaluate the safety and pharmacokinetics of RX-0201, as well as any antitumor response.

• SinusPharma Inc., of Carpinteria, Calif., initiated a Phase I trial of SPRC-AB01, a formulation of an antibiotic for nasal inhalation. The trial in healthy volunteers will test the safety of various doses prior to clinical trials in chronic rhinosinusitis patients. The Phase I trial should complete by November.

• SuperGen Inc., of Dublin, Calif., and MGI Pharma Inc., of Minneapolis, said SuperGen's subsidiary, EuroGen Pharmaceuticals Ltd., submitted a marketing authorization application for Dacogen (decitabine) for injection to the European Agency for the Evaluation of Medicinal Products. Dacogen is a cancer therapeutic for the treatment of patients with myelodysplastic syndromes. MGI Pharma has exclusive worldwide rights to the development, manufacture, commercialization and distribution of Dacogen. The companies expect to complete a new drug application filing in the fourth quarter.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., said its cancer compound, TPI-273, shows inhibitory activity in a variety of tumors in in vitro studies, exceeding the potency of paclitaxel and docetaxel. TPI-273 demonstrated in vitro activity in taxane-resistant tumor cell lines. The compound also exhibits antitumor activity in human xenografts in mice. TPI-273 is a semi-synthetic analogue of glaucoubolone, a natural compound found in quassia plants. Its basic mechanism of action appears to be protein-synthesis inhibition, which in turn causes additional effects including suppression of cell-growth proteins and cytostasis by impeding tumor-cell cycling. The data were presented at the 16th EORTC-NCI-AACR meeting in Geneva.

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