• Arena Pharmaceuticals Inc., of San Diego, said data from a Phase Ia single-dose trial of its obesity compound, APD356, showed evidence of a pharmacologic effect on food intake with a 10-mg dose. APD356 also was shown to have a half-life of about 11 hours, which could support once-daily dosing. Food did not affect the absorption of APD356, which is an orally administered small molecule that is a selective 5-HT2C serotonin receptor agonist.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Evotec Neurosciences GmbH, of Hamburg, Germany, signed an agreement in mouse genetics. As part of the cooperation, Artemis will apply its ArteMice technology platforms to assist Evotec in the generation of genetically engineered mouse models. Financial details were not disclosed.

• Biomira Inc., of Edmonton, Alberta, received final clearance from Canadian regulatory authorities for a $100 million shelf prospectus. Biomira concurrently filed a shelf registration statement in the U.S. Biomira had a shelf registration in place that expired in May. The company is planning a Phase III trial for BLP25 liposomal vaccine in non-small-cell lung cancer, and it plans to advance its Theratope vaccine into late-stage trials. Both products are expected to require confirmatory studies before Biomira can file for approval in the U.S. and Europe.

• Can-Fite BioPharma Ltd., of Petach-Tikva, Israel, is finalizing its reincorporation as a U.S. company and has appointed New Jersey-based Ashley Palmer as CEO. Palmer joined Can-Fite in February as the U.S.-based chief business officer. Palmer was the founding CEO of INO Therapeutics Inc. Can-Fite originally was an Israeli company that began operations at the end of 2000. It is engaged in two Phase II trials of its lead drug CF101, one for the treatment of colorectal cancer and the other for rheumatoid arthritis.

• Celera Genomics Group, of South San Francisco, said Structure published details of the first 3-dimensional X-ray crystal structure of human histone deacetylase 8 (HDAC8). Celera Genomics and Syrrx Inc., of San Diego, determined the structure of HDAC8 bound to an experimental HDAC inhibitor synthesized by Celera, as well as the structures of other HDAC inhibitors under evaluation by other parties.

• Cell Therapeutics Inc., of Seattle, filed a prospectus supplement related to an underwritten offering of 8 million common shares under an existing shelf registration statement. In connection with the offering, the company expects to grant the underwriters an overallotment option to purchase up to 1.2 million additional shares. UBS Securities LLC and CIBC World Markets are acting as joint book-running managers, with co-management from WR Hambrecht + Co., Delafield Hambrecht Inc. and Punk, Ziegel & Co. Cell Therapeutics, an oncology drug development company, is selling all the shares.

• Celltech Group plc, of Slough, UK, applied to cancel the listing of its ordinary shares on the UK Listing Authority and on the London Stock Exchange. The company, which two months ago agreed to be bought for $2.7 billion by UCB SA, of Brussels, Belgium, expects the cancellation to take effect next month. After that, Celltech also expects that the New York Stock Exchange will delist its American depository receipts. (See BioWorld Today, May 19, 2004.)

• Cytomedix Inc., of Little Rock, Ark., began patient treatment in a clinical study of its AutoloGel System, an autologous platelet gel composed of multiple growth factors and fibrin matrix, which is used to treat chronic wounds. The study against the standard of care for the treatment of chronic diabetic foot ulcers will be conducted at more than a dozen U.S. sites. The goal of the trial is to confirm the safety and efficacy of the product, as well as to reduce amputation rates and improve the quality of life for patients.

• CytRx Corp., of Los Angeles, Advanced BioScience Laboratories, of Kensington, Md., and the University of Massachusetts Medical School said investigators have enrolled and inoculated the first patients in the Phase I trial for an experimental HIV vaccine developed by the university and ABL. The National Institute of Allergy and Infectious Diseases is providing about $16 million total for the trial, which should last 18 months. The trial will enroll 36 people who do not have HIV. The vaccine contains only portions of the HIV genome and participants cannot get HIV from the vaccine. Subjects will be observed for any adverse effects and will have samples collected in order to measure immune responses. The vaccine incorporates DNA and protein technology that the university and ABL have exclusively licensed to CytRx.

• DOR BioPharma Inc., of Miami, completed patient enrollment in a multicenter, pivotal Phase III trial of orBec (oral beclomethasone dipropionate) to treat acute intestinal graft-vs.-host disease. The treatment phase of the trial is expected to conclude in September, and DOR plans to have unblinded data available in the fourth quarter. The company anticipates filing a new drug application with the FDA in the first quarter of 2005. OrBec has orphan drug and fast-track designations.

• Epimmune Inc., of San Diego, said the National Institute of Allergy and Infectious Diseases provided a written notice of its intention to exercise a three-year, $2.8 million contract option for Epimmune to conduct preclinical development of a multi-epitope malaria vaccine. The decision follows successful demonstration by Epimmune of preclinical feasibility of a vaccine that would target all strains of malaria in all human ethnicities. The company also presented early data from an ongoing Phase I trial of its EP HIV-1090 therapeutic vaccine for HIV-infected patients. The data, summarized at the 15th International AIDS Conference in Bangkok, Thailand, showed that all patients in each of four dose groups displayed no serious adverse events and that disease-specific indicators such as CD4+ T-cell counts have remained stable. The vaccine appears to be safe and well tolerated at all dose levels.

• Generex Biotechnology Corp., of Toronto, received about $1.8 million of an anticipated $3 million through a private placement of common stock and warrants to four investors. When the complete $3 million has been received, the company will have issued an aggregate of about 2.5 million units, consisting of a total of 2.5 million shares of common stock and warrants exercisable for a total of nearly 2 million shares of common stock. The exercise price for each warrant is $1.68. The investors also received additional investment rights.

• GlaxoSmithKline plc, of London, said findings reported at the International AIDS Conference in Bangkok, Thailand, showed that the frequency of moderate to severe drug-related diarrhea was significantly lower in HIV-infected patients taking Lexiva (fosamprenavir calcium) compared to those taking nelfinavir, according to 48-week data from SOLO and NEAT studies. The pivotal trials played a role in Lexiva's FDA approval last fall for the treatment of HIV infection in adults in combination with other antiretrovirals. A protease inhibitor, Lexiva was co-discovered with Vertex Pharmaceuticals Inc., of Cambridge, Mass.

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said data published in the May issue of Cancer Cell demonstrated that the administration of AEOL 10113 inhibits the regrowth of tumors following radiation therapy in a mouse model of cancer. The effect results from preventing radiation-induced up-regulation of hypoxia inducible factor-1 (HIF- 1). When the compound, which stems from the company's class of catalytic antioxidants, was given once a day for three days, it blocked HIF-1 activation in tumors following radiation therapy, preventing angiogenesis and delaying tumor growth.

• Kosan Biosciences Inc., of Hayward, Calif., initiated a company-sponsored Phase I trial to investigate 17-allylamino-17-demethoxy-geldanamycin in patients with relapsed and relapsed/refractory multiple myeloma. The trial will evaluate the formulation and establish the safety, pharmacokinetics and pharmacodynamics of escalating doses of KOS-953 in patients with previously treated advanced multiple myeloma.

• Lynx Therapeutics Inc., of Hayward, Calif., said a manuscript in the June issue of Plant Physiology describes the use of publicly available data from Lynx's Massively Parallel Signature Sequencing gene-expression technology and computational algorithms to better understand the regulation of gene expression on a genome-wide scale. The research analyzes the relationship between certain structural features of chromosomes and gene expression.

• Manhattan Pharmaceuticals Inc., of New York, reported Phase I results showing that use of its lingual spray formulation of propofol did not produce serious adverse events or dose-dependent changes in vital signs. The mean time to maximum blood concentration of propofol after spray was about 30 minutes across all doses, and it was detectable in blood as early as four minutes after administration. The mean maximum blood concentrations reached plateau at the highest of the three doses tested, and the mean bioavailability of the current spray formulation was up to 18 percent of that of the intravenous formulation. Propofol is being developed in collaboration with Novadel Pharma Inc., of Flemington, N.J.

• MannKind Corp., of Valencia, Calif., set a range of $13 to $15 per share in its initial public offering of 5.5 million shares. All the shares are to be sold by the company, which is developing therapeutic products for diabetes, cancer, inflammatory and autoimmune diseases. It registered for the IPO two months ago. (See BioWorld Today, May 4, 2004.)

• MGI Pharma Inc., of Minneapolis, entered a three-year agreement to promote Kadian, a sustained-release morphine sulfate product from Alpharma Inc., of Fort Lee, N.J. MGI plans to market Kadian to U.S. oncology professionals for moderate to severe pain associated with cancer. Alpharma markets the product to pain specialists in the U.S. Initially, the companies will equally share profits related to sales of Kadian for oncology applications. Additional terms were not disclosed. Separately, MGI reported second-quarter earnings of 11 cents per share, ahead of consensus estimates of 5 cents per share.

• MorphoSys AG, of Munich, Germany, and Novoplant GmbH, of Gatersleben, Germany, signed a collaboration for the development of therapeutic antibodies in animal health applications. Under the three-year agreement, Novoplant received a license from MorphoSys for the development and commercialization of therapeutic antibodies as feed components for use in veterinary medicine. Novoplant will pay a technology-access fee to MorphoSys for the use of the HuCAL Gold technology in addition to annual licensing fees. Additionally, MorphoSys could receive milestone fees and royalties for the development and marketing of any resulting products.

• Nymox Pharmaceutical Corp., of Maywood, N.J., reported that the new clinical trial protocol for the company's investigational new drug NX-1207 for benign prostastic hyperplasia was found acceptable by the FDA. The company will be proceeding into pivotal Phase II testing of NX-1207.

• Panacos Pharmaceuticals Inc., of Gaithersburg, Md., said Phase I data on its HIV candidate PA-457 presented at the International AIDS Conference in Bangkok, Thailand, showed it was well tolerated at all doses, offered good oral bioavailability and favorable pharmacokinetics. All doses produced mean circulating plasma levels that exceeded the target therapeutic concentration, suggesting PA-457 is suitable for once-daily oral dosing. Panacos has advanced it into a multidose Phase I study to examine safety and pharmacokinetics.

• Pharming Group NV, of Leiden, the Netherlands, entered an agreement to obtain broad licenses to patents belonging to Infigen Inc., of DeForest, Wis. More specifically, Pharming gained worldwide, nonexclusive, royalty-free, non-terminable licenses from Infigen for patents on nuclear transfer and associated technologies. The licensing agreement will replace earlier agreements between the companies, and Infigen will relinquish claims to any milestone payments for product development as defined under earlier agreements. Financial terms were not disclosed.

• Progen Industries Ltd., of Brisbane, Australia, reported the beginning of the fourth and the largest in the series of PI-88 Phase II trials. The trial will evaluate PI-88, the company's lead cancer compound, in patients with primary liver cancer following surgical removal of the primary tumor. The objective of the trial will be to determine the number of patients with recurrence over 48 weeks post-surgery with or without PI-88 as adjuvant therapy.

• Proteo Biotech AG, of Kiel, Germany, said that Elafin, which is produced in a recombinant process, passed all preclinical trials focusing on its effectiveness and compatibility. Elafin is an inhibitor of human elastase and proteinase 3, and the company said it shows promise in the treatment of tissue and muscle damage.

• QLT Inc., of Vancouver, British Columbia, and Atrix Laboratories Inc., of Fort Collins, Colo., reported that the Federal Trade Commission granted early termination of the waiting period related to the companies' proposed merger. The $855 million transaction remains subject to various closing conditions. The proposed merger was reported on June 14. (See BioWorld Today, June 15, 2004.)

• Symbollon Pharmaceuticals Inc., of Framingham, Mass., said data published in this month's online edition of The Breast Journal details the connection between the use of iodine and breast cancer prevention. The company said it plans to test whether iodolipids are present in the breast duct fluid of patients on IoGen, its compound in Phase I and II trials evaluating its use for treating moderate to severe cyclic pain and tenderness associated with fibrocystic breast disease.

• Vivus Inc., of Mountain View, Calif., said data from a recently completed Phase II trial showed Alista significantly increased the percentage of satisfying sexual events in premenopausal women with female sexual arousal disorder compared to placebo. Data showed that 64 percent of Alista doses resulted in satisfying sexual events, and that patients experienced an increase in the total number of satisfying sexual encounters compared to placebo. The study evaluated Alista in 36 women in the home setting. Vivus' stock (NASDAQ:VVUS) jumped 68 cents, or 18 percent, to close at $4.46.

• XenoPort Inc., of Santa Clara, Calif., began two Phase IIa trials with XP13512, a Transported Prodrug of gabapentin, to treat restless legs syndrome and post-herpetic neuralgia. The results are expected later this year or early in 2005. XenoPort also said data from three additional Phase I studies further demonstrate the tolerability and favorable pharmacokinetics of XP13512 administered orally to healthy human subjects. The study showed that steady-state concentrations of gabapentin in blood were reached by the third day at the targeted dose.

• Xenova Group plc, of Slough, UK, reported initial results from the second clinical trial of TA-NIC, the company's therapeutic vaccine being developed for the treatment of nicotine addiction. Sixty smokers were recruited into the study. No drug-related serious adverse events were seen in any cohort and faster and more rapid onset of anti-nicotine antibody response was achieved.

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