• Acadia Pharmaceuticals Inc., of San Diego, said findings published in the July 16, 2004, issue of Psychopharmacology show that ACP-104, the principal metabolite of clozapine, stimulates m1 muscarinic receptors in brain nerve cells that play an important role in cognition. The company is developing ACP-104 for schizophrenia, with the added potential for improving cognitive function. The published research was conducted in collaboration with scientists at Vanderbilt University in Nashville, Tenn.

• Accelr8 Technology Corp., of Denver, completed the sale of its software business, which consists of tools for legacy-code modernization and the resale of third-party software. The transaction, valued at about $700,000, will enable the company to concentrate its resources on advancing the biosciences side of its business, notably the development of the BACcelr8r, a rapid-response microbial diagnostic platform intended initially for use in the identification of bacterial infections in critically ill patients.

• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., said an article published in last month's Drug Discovery Today examines the role of antioxidant mimetics as therapeutics, and it highlights compounds under development at Aeolus. The author documents expanding evidence that overproduction of reactive oxygen molecules, commonly called free radicals, plays a central role in a variety of pathologies. Aeolus said the most frequently cited compounds were its catalytic antioxidants, which were included in 45 of the 68 referenced publications.

• Allos Therapeutics Inc., of Westminster, Colo., said the FDA awarded orphan drug status to its lead clinical candidate, Efaproxyn (efaproxiral), for use as an adjunct to whole-brain radiation therapy for treating brain metastases in breast cancer patients. The product remains in a Phase III trial in that indication. Allos' stock (NASDAQ:ALTH) gained 47 cents Tuesday, or 28.7 percent, to close at $2.11.

• Antares Pharma Inc., of Exton, Pa., said its Japanese licensee, JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan, launched the Twin-Jector EZ II, a new product that combines Antares Pharma's Vision needle-free injection technology with JCR's human growth hormone. Antares Pharma will receive manufacturing margins on sales of devices as well as royalties on the end sales of human growth hormone used in conjunction with the needle-free technology.

• Applied Biosystems, of Foster City, Calif., released the new version of its SNPbrowser Software tool that includes data on 20 million genotypes obtained from 160,000 single nucleotide polymorphisms (SNPs) typed on 180 individuals across four populations. The software is designed to simplify the selection of SNPs for disease association studies and facilitate the ordering of Applied Biosystems' collection of 1.8 million TaqMan SNP Genotyping Assays.

• BioDelivery Sciences International, of Newark, N.J., agreed to enter a credit facility of up to $4 million with Hopkins Capital Group II LLC, which is controlled and partially-owned by BDSI's chairman and CEO Francis O'Donnell. BDSI will use proceeds for general corporate purposes, including supporting the company's drug delivery nanotechnology. All debt funded will have a maturity of March 31, 2006. HCG may then convert any amount outstanding into shares of BDSI common stock at $4.25 per share. BDSI also said it will soon receive up to $275,000 from board members that exercise their option to purchase common stock.

• Biophage Pharma Inc., of Montreal, raised C$498,850 (US$378,722) in aggregate proceeds through a private placement of about 4.8 million units at about C10 cents apiece. Each unit includes one common share and a 0.30 common share purchase warrant; each whole warrant entitles the holder to purchase one common share at C25 cents at any time within two years from the offering's closing date. Biophage said it would use the funding to accelerate its development of therapeutic and diagnostic applications for phage products and for working capital purposes.

• ChondroGene Ltd., of Toronto, said an article published in Genomics details its mapping of cartilage transcripts to the human genome. The company used functional genomics methods and its human cartilage bank to catalogue 13,000 to 16,000 genes expressed in cartilage tissue. Mapping the cartilage-expressed genes to the human genome revealed a higher level of organization than expected, ChondroGene said, and resulted in the definition of numerous hotspot chromosome regions containing clusters of cartilage-expressed genes. It applied the information to construct its ChondroChip, a 15,000-element, cDNA-based microarray that it developed for use in its osteoarthritis programs.

• Columbia Laboratories Inc., of Livingston, N.J., said Phase III results published in this month's Journal of Clinical Endocrinology and Metabolism demonstrate that Striant (testosterone buccal system) (CIII) 30 mg is a safe and effective treatment for testosterone replacement in hypogonadal men when applied twice daily, with no dose adjustment required. The data provided the basis for FDA approval of the product, which uses the company's progressive hydration buccal technology to deliver testosterone via the buccal cavity. Columbia said it is investigating additional product candidates using its delivery system.

• CytoGenix Inc., of Houston, completed preclinical animal safety studies that show the company's lead DNA anti-herpes topical compound is safe in three species of animals. A third-party laboratory conducted the tests operating under FDA Good Laboratory Practices regulations and following United States Pharmacopeia (USP) testing standards for topical products.

• eXegenics Inc., of Pittsford, N.Y., said it plans to appeal a Nasdaq determination to delist its common stock. Last month, the company received notification that it is not in compliance with the minimum $1 closing bid price per share requirement. eXegenics was advised that the delisting will be stayed pending the Nasdaq panel's decision.

• Guilford Pharmaceuticals Inc., of Baltimore, said its brain cancer treatment Gliadel Wafer was assigned to a new Diagnosis Related Group, DRG 543, by the Centers for Medicare and Medicaid Services. The new DRG will take effect on Oct. 1 and should improve access to Gliadel Wafer by providing increased payment to hospitals that provide it to Medicare beneficiaries. The product is approved for use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation, and in patients with recurrent glioblastoma multiforme as an adjunct to surgery and radiation.

• Hemispherx Biopharma Inc., of Philadelphia, entered definitive agreements with selected accredited institutional investors, including current shareholders, to raise about $7.5 million in gross proceeds through a stock-and-warrant sale. The company, which is developing products for viral and immune-based chronic disorders, agreed to a private placement of about 3.6 million common shares and warrants to purchase up to about 1.1 million additional shares at $2.08 apiece. The five-year warrants are exercisable at $2.86 per share. Subject to customary closing conditions, the placement is scheduled to close this week.

• Ligand Pharmaceuticals Inc., of San Diego, ended its four-year relationship with Deloitte & Touche LLP as the company's independent registered accounting firm. D&T resigned as the company's independent auditors after filing the quarterly report for the period ended June 30. Ligand's senior vice president and chief financial officer Paul Maier said the two parties have had no disagreements related to financials and classified the timing of the resignation as "coincidental." The company reported its second-quarter results, showing $40.5 million in total revenues and a net loss of $14.2 million, or 19 cents per share. Analysts had predicted a loss of 6 cents per share. The company's stock (NASDAQ:LGND) dropped 39.8 percent, or $5.40 on Tuesday, to close at $8.18.

• MacroChem Corp., of Lexington, Mass., said top-line results from a pharmacokinetics study of Opterone demonstrated that the company's SEPA technology delivered testosterone into the bloodstream within the first few hours of application. Opterone cream also provided more sustained delivery of testosterone over 24 hours when compared with its first-generation gel formulation of the male testosterone deficiency product.

• Metabasis Therapeutics Inc., of San Diego, initiated a multicenter Phase II trial to evaluate orally administered remofovir mesylate in chronic hepatitis B infected patients. The company partnered in October 2001 with Costa Mesa, Calif.-based Valeant Pharmaceuticals International Inc., which is responsible for the clinical development and registration of remofovir. The Phase II, open-label, randomized study will evaluate multiple oral doses and will enroll 220 patients at 20 sites in the U.S., Taiwan, Singapore and Korea. The study consists of five treatment groups, four with remofovir at different doses, and one with Hepsera (adefovir dipivoxil). Patients will receive treatment for 48 weeks, with an interim analysis being conducted following 24 weeks.

• Myogen Inc., of Denver, said the FDA granted orphan drug designation to ambrisentan for the treatment of pulmonary arterial hypertension (PAH). The drug is being evaluated for PAH in two pivotal Phase III trials. Ambrisentan is a type-A selective endothelin receptor antagonist and inhibitor of endothelin-induced vasoconstriction.

• Nektar Therapeutics, of San Carlos, Calif., entered a licensing agreement with New York-based Pfizer Inc. that will involve Bridgewater, N.J.-based Enzon Pharmaceuticals Inc.'s PEG technology. Nektar will provide Pfizer PEGylation technology for an undisclosed product in clinical testing. Enzon will receive a share of Nektar's royalties or profits on any potential sales. Under their 2002 alliance, Nektar has the exclusive right to grant sub-licenses for Enzon's PEG technology to third parties.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said it is developing a product called NXC-4720 to address E. coli O157:H7 contamination at the stage of meat production. The company noted that the product has been validated in independent tests and is involved in ongoing validation studies.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., said its president and CEO, Steven Rauscher, was scheduled to preside over today's opening of the Nasdaq market. The company's ticker symbol changed to "OSCI" today.

• Pepgen Corp., of Alameda, Calif., raised more than $7.5 million through a preferred stock financing. The company said it would use a portion of the funding to complete a Phase II study of its lead product, Tauferon, in multiple sclerosis. The funding also will be used to explore additional indications for the orally active product, and for preclinical development of Neoferon for other autoimmune diseases and viral infections. Toucan Capital led the financing round, with participation from Biotechnology Development Funds, Valley Ventures, Asset Management Company, Veron International and others.

• Point Therapeutics Inc., of Boston, said top-line conclusions from an ongoing Phase I trial showed that talabostat could be safely administered in combination with rituximab for B-cell malignancies. Data from the dose-ranging study also showed that certain cytokines and chemokines were up-regulated in most patients, the company told investors at its annual meeting, and antitumor activity was also observed in some patients. Point Therapeutics also unveiled a preclinical program for a third boroproline compound, PT-630, in Type II diabetes. To date, PT-630 is orally bioavailable and has demonstrated affinity for and inhibition of DPP-4 (dipeptidyl peptidase-4), which degrades GLP-1(glucagon-like peptide-1), a peptide that stimulates insulin secretion.

• Procyon Biopharma Inc., of Montreal, said findings published in the Aug. 1, 2004, issue of Cancer Research demonstrate the efficacy of PCK3145 in reducing tumor volume and delaying the development of skeletal metastases in a preclinical Mat Ly Lu model of prostate cancer. The company said the data are in line with Phase IIa results from a study of metastatic hormone-refractory prostate cancer patients, supporting its belief that PCK3145 affects the metastatic process by modulating the production of matrix metalloproteinase-9 (MMP-9), an enzyme involved in tumor invasion and metastasis. Advanced late-stage prostate cancer usually results in spreading of metastatic cancer to the bone and subsequently leading to severe bone pain. The findings were produced in collaboration with researchers from McGill University in Montreal.

• The Medicines Co., of Parsippany, N.J., said Dave Stack is stepping down from his role as president and CEO to spend more time with his family. Executive Chairman Clive Meanwell is reassuming the title of CEO and remains chairman. Stack will remain with the firm to assist Meanwell with the transition of the CEO responsibilities and will work on strategic projects through April 2005. Also, Brent Furse, previously vice president of sales, has become vice president and general manager, emergency department and endovascular therapeutics, and is assuming Stack's commercial responsibilities.

• Transkaryotic Therapies Inc., of Cambridge, Mass., entered an agreement in which Lonza Biologics plc, of Slough, UK, will manufacture Dynepo, TKT's gene-activated erythropoietin product. Lonza will do the work at its production facility in Slough for an undisclosed amount. Dynepo is approved for commercial use in the European Union for the treatment of anemia associated with kidney disease.

• Trinity Biotech plc, of Dublin, Ireland, received clearance from the FDA to market its Captia HSV IgG Type Specific ELISAs in the U.S. The products are approved for the detection of IgG antibodies to HSV 1 and HSV 2 in human serum. The Captia HSV type specific ELISAs use recombinant glycoproteins gG-1 and gG-2, which are type specific for HSV-1 and HSV-2 antibodies, respectively, Trinity said.

• V.I. Technologies Inc., of Watertown, Mass., recruited 24 sites to participate in its acute transfusion Phase III trial of the Inactine system. The company believes it will complete patient enrollment and follow-up in the first quarter of 2005, with initial data becoming available in mid-2005. The company intends to complete Phase III trials before entering into definitive discussions with potential partners. Inactine is designed to inactivate viruses, bacteria and parasites in units of red blood cells.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., initiated a Phase II study of its antiviral compound, remofovir mesylate. Valeant is developing remofovir in oral form for the treatment of compensated chronic hepatitis B. Remofovir is a pro-drug of adefovir that was licensed from Metabasis Therapeutics. The study is an open-label, randomized, multiple dose study that will enroll 220 patients at about 20 sites.

• Valera Pharmaceuticals, of Cranbury, N.J., formerly known as Hydro Med Sciences, completed enrollment in a Phase II study of its octreotide containing implant. Using the company's patented Hydron drug delivery platform, the implant was developed to provide continuous six-month administration of octreotide acetate for treating acromegaly. Valera is optimistic that the study will complete by the year's end.

• Viral Genetics Inc., of Azusa, Calif., began enrollment in a South African clinical trial of VGV-1, a purified protein formerly called Thymus Nuclear Protein that is extracted from a bovine thymus gland, which has been examined in previous clinical trials of HIV-infected individuals. It will enroll 80 HIV-1 patients who will be treated with VGV-1 or placebo for 51 days, followed by 240 days of follow-up. The endpoint is the amount of viral load, and the trial also will monitor safety and immunological function.

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