• Acura Pharmaceuticals Inc., of Palatine, Ill., began Phase I studies of its lead product, Product Candidate Number 1, which incorporates Acura's abuse-deterrent formulation technology into a tablet formulation for oral administration. The product is being developed to deter abuse of opioid-containing, orally administered prescription products.

• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., initiated a Phase I trial of AEOL 10150 in patients diagnosed with amyotrophic lateral sclerosis. The trial will involve six dosing cohorts, with five ALS patients per cohort. One of the five will receive placebo. Each single dose will be increased as the trial progresses. The Phase I trial will be conducted at six clinical sites, and the study should be completed in the first quarter.

• AEterna Zentaris Inc., of Quebec, said the peer-reviewed Clinical Infectious Diseases journal published data demonstrating the therapeutic use and favorable tolerability of Impavido (oral miltefosine) as initial and maintenance treatment of recurrent visceral leishmaniasis. The results come from a compassionate-use program of oral miltefosine in 39 HIV-infected patients, who had failed at least one and as many as nine prior courses of standard therapy for leishmaniasis and were receiving antiviral combination therapy for HIV. The initial response and initial cure rates were 64 percent and 41 percent, respectively. Miltefosine was generally well tolerated, with no dose-limiting side effects or adverse interactions with antiviral therapy. The most frequent side effects were gastrointestinal, including vomiting, nausea and diarrhea.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said the November issue of Blood published three abstracts on the clinical development of forodesine hydrochloride, its lead candidate to treat certain leukemias and lymphomas. Two of the abstracts will be presented at the American Society of Hematology meeting in San Diego in December. One abstract shows how intravenous forodesine (BCX-1777) demonstrated clinical activity in nine out of 13 patients with refractory cutaneous T-cell lymphoma. Another abstract shows how BCX-1777 demonstrated clinical activity in Phase I/II studies in patients with B-cell acute lymphoblastic leukemia. The third abstract presented an analysis of the Phase I/II data demonstrating that BCX-1777 was generally safe and well tolerated at all dose levels with no dose-limiting toxicities.

• Boston Life Sciences Inc., of Boston, prepaid the outstanding principal plus accrued interest on its 10 percent convertible senior secured promissory notes due June 1. Their $4.4 million face amount was held by Ingalls & Snyder Value Partners LP, and the payment was made with funds previously set aside in a restricted account to collateralize the notes. BLSI agreed to lower the exercise price of warrants to purchase 500,000 shares of its common stock presently held by Ingalls & Snyder from $2.16 to $1 per share, and will record a charge of about $50,000 this quarter. BLSI is developing products for the diagnosis and treatment of central nervous system diseases.

• Cengent Therapeutics Inc., of San Diego, signed a drug discovery contract with Dynamis Therapeutics Inc., of Wyndmoor, Pa. Cengent will apply its Genes To Leads identification technology to screen for candidates against diabetic-related kidney and heart disease, blindness and neuropathy. Dynamis' drug target is an enzyme that causes the formation of 3-deoxyglucosone, an adversely reactive molecule that causes free radicals and AGEs to form. The deal includes undisclosed up-front and milestone payments.

• ChondroGene Ltd., of New York, received a $1 million payment from Pfizer Inc., of New York, as the third and final research milestone in a two-year deal. ChondroGene, which already received two $1 million milestone payments, worked with Pfizer to identify therapeutic targets and diagnostic biomarkers for osteoarthritis. The collaboration was completed last month, though the parties are in late-stage negotiations on a second agreement in osteoarthritis.

• Columbia Laboratories Inc., of Livingston, N.J., said its board elected Stephen Kasnet chairman and Edward Blechschmidt vice chairman, replacing Fred Wilkinson and Jim Apostolakis, respectively. Kasnet and Blechschmidt have served as independent directors on the board since August. Wilkinson remains president and CEO. Wilkinson and Apostolakis also will continue as directors. Columbia is a pharmaceutical company focused on women's health care and endocrinology products.

• Commonwealth Biotechnologies Inc., of Richmond, Va., executed a variable-rate mortgage with Branch Banking and Trust Co. for its home facility. The mortgage replaces two series of industrial revenue bonds, issued in 1998, which were used to finance construction of the company's physical plant. The bank provided $3.9 million, which is sufficient to retire the bonds and meet pre-payment penalties and legal expenses. In retiring the bonds, net proceeds of about $461,000 will be released to the company.

• Dyax Corp. and Genzyme Corp., both of Cambridge, Mass., reported final results from the EDEMA1 trial at the American College of Allergy, Asthma and Immunology meeting in Boston showing DX-88 achieved statistical significance with respect to the primary endpoint, improvement of hereditary angioedema symptoms within four hours of administration. Specifically, 72 percent of patients treated with DX-88 reported significant improvement of the symptoms within four hours of administration, as opposed to a 25 percent response rate in the placebo group (p=0.0169). The recombinant small protein was safe and well tolerated, and was effective at treating all types of hereditary angioedema attacks, including potentially fatal laryngeal attacks.

• Dynavax Technologies Corp., of Berkeley, Calif., shared data from preclinical models showing immunostimulatory-sequence (ISS)-based peanut immunotherapy demonstrated inhibition of allergic responses and induction of therapeutic immune responses to peanut allergen. Dynavax's peanut allergy candidate consists of ISS linked to the peanut allergen, Ara h 2. The data showed that ISS linked to Ara h 2 administered to mice resulted in inhibition of immunoglobulin G1 and interleukin-5, mediators associated with the pathway that causes the allergic response.

• Endocyte Inc., of West Lafayette, Ind., received more than $3.5 million in federal and state grants to complete preclinical research on tumor-targeted chemotherapeutics. The research involves using the vitamin folate to transform cancer drugs into smart drugs that bypass normal cells in favor of diseased ones. An award of about $1.6 million from the National Cancer Institute will be dispersed over a three-year period, while a state grant from the Indiana 21st Century Research and Technology Fund will be spread over two years.

• ExonHit Therapeutics SA, of Paris, entered a research collaboration to combine its alternative RNA-splicing technologies with a microarray platform from Agilent Technologies Inc., of Palo Alto, Calif. The partners are working together to optimize microarray design, reagent protocols and data-analysis methods for splice variant studies. Financial terms were not disclosed.

• Forest Laboratories Inc., of New York, said the FDA accepted the filing of its supplemental new drug application to expand the indication of Namenda to include treatment of mild Alzheimer's disease. The drug is available for moderate and severe Alzheimer's patients. The sNDA filing includes data from three studies, including one that showed patients treated with Namenda performed significantly better than placebo-treated patients on two measures, one for cognitive function, and the other looking at the patient's overall status. Forest expects to receive an initial action letter from the FDA by the third quarter of 2005. Namenda, which was developed in partnership with Neurobiological Technologies Inc., of Richmond, Calif., first was approved in October 2003.

• Gamida-Cell Ltd., of Jerusalem, said its Phase I/II study of StemEx for leukemia suggested its flagship product is safe. StemEx is composed of ex vivo expanded cord blood stem/progenitor cells combined with non-expanded cells from the same unit. It reduced the occurrence of GvHD and shortened the time to platelet engraftment. Other clinical parameters, such as short-term survival of patients who had undergone a transplant, also improved, the company said.

• Geron Corp., of Menlo Park, Calif., said the Journal of Immunology published a study that supports the development of the company's small-molecule telomerase activators to treat patients with HIV. The study demonstrates how the use of telomerase activation increases the lifespan and augments the antiviral activities of HIV-specific immune cells. Geron provided the University of California at Los Angeles the telomerase gene used in the study.

• Hemagen Diagnostics Inc., of Columbia, Md., extended its offer to exchange $6.1 million in 8 percent senior subordinated secured convertible notes due 2005 for common stock and modified notes. The new expiration date is Nov. 19. About $5.3 million, or 87 percent of the principal amount of the notes, have been deposited for exchange to date. Hemagen focuses on diagnostic test kits for certain autoimmune and infectious diseases.

• HTS Biosystems, of Hopkinton, Mass., said its Flexchip Kinetic Analysis System is being used for antibody and protein-interaction research at Genentech Inc., of South San Francisco, and at the University of Utah Center for Biomolecular Interaction Analysis. The product is a real-time, label-free detection array platform.

• Hybridon Inc., of Cambridge, Mass., said preclinical findings reported at the American College of Allergy, Asthma and Immunology meeting showed that its immunomodulatory oligonucleotide (IMO) DNA-activated immune cells that produce certain specific cytokines are important to regulating Th1-type and Th2-type immune responses - a process for treating severe allergy and asthma conditions. The data showed that, in mouse models, oral administration of second-generation IMO compounds can suppress allergic responses in the lung.

• LION bioscience AG, of Heidelberg, Germany, said it will voluntarily delist its American depository shares from the Nasdaq National Market and terminate its American depository receipt facility, effective at the close of trading on Dec. 22.

• MedImmune Inc., of Gaithersburg, Md., began a Phase III study to evaluate Numax's safety and efficacy in reducing respiratory syncytial virus (RSV) in healthy, full-term Native American (Navajo and White Mountain Apache) infants. Recent data indicate that the risks associated with RSV for otherwise healthy, full-term Native American infants are similar to those commonly associated with children considered to be at high risk to the virus, including children born prematurely or with chronic lung disease or congenital heart disease. In addition to the risk from RSV itself, Native American children have a high rate of wheezing and asthma, the company said. Earlier this month, MedImmune began another Phase III study to compare Numax to Synagis (palivizumab), its monoclonal antibody approved in 1998 for RSV. (See BioWorld Today, Nov. 2, 2004.)

• Morphotek Inc., of Exton, Pa., and SC BioSciences, of Tokyo, entered a collaboration in which SCB will serve as the Japanese marketing partner for Morphotek's cell line optimization services. That includes Morphotek's Morphodoma technology, which involves antibody production cell lines to generate subclones producing protein products with enhanced therapeutic efficacy, as well as genetically enhanced cells exhibiting high titers of protein for scaleable manufacturing.

• The Nasdaq Stock Market Inc., of New York, completed its semi-annual re-ranking of the Nasdaq Biotechnology Index. As a result, 11 securities will be added to the index, including Discovery Laboratories Inc., of Doylestown, Pa.; Santarus Inc., of San Diego; Bone Care International Inc., of Middleton, Wis.; and Bioenvsion Inc., of New York. Removals from the index include Biopure Corp., of Cambridge, Mass., and Idexx Laboratories Inc., of Westbrook, Maine. The changes will become effective Nov. 22.

• NexMed Inc., of Robbinsville, N.J., closed enrollment for its 400-patient study of Femprox in China. The study is designed to test the efficacy and safety of Femprox cream in women diagnosed with female sexual arousal disorder. Femprox incorporates alprostadil with the NexACT permeation enhancer. The company intends to use the results from the study to define its U.S. Phase II/III plan for Femprox.

• Palatin Technologies Inc., of Cranbury, N.J., presented data from preclinical studies that indicate the company's small-molecule, melanocortin receptor subtype-4-selective agonist reduces food intake and body weight without the side effects normally associated with non-selective, melanocortin receptor agonists such as melanotan-II. Palatin's findings indicate that melanocortin is a potential treatment for obesity. The data were presented at the North American Association for the Study of Obesity 2004 annual scientific meeting in Las Vegas.

• Serologicals Corp., of Atlanta, formed a third operating division, Celliance, to focus on expanding the company's presence in the bioprocessing market. The division is responsible for the research, development, manufacturing and commercialization of Serologicals' cell culture supplement and diagnostic products, as well as contract research services through Sierra BioSource.

• SRI International, of Menlo Park, Calif., received a five-year, $6.3 million contract from the National Institute on Aging to evaluate the preclinical safety and pharmacology of potential therapeutics for treatment of Alzheimer's and other diseases associated with aging. The institute will use SRI's preclinical studies to support investigational new drug applications submitted to the FDA to perform clinical studies.

• Stanford University in Stanford, Calif., said that its researchers showed in mice for the first time that mast cells can provide protection from sepsis by destroying a molecule that contributes to the pathology and death associated with the bacterial infection.

• SuperGen Inc., of Dublin, Calif., received approval from the FDA of its abbreviated new drug application for paclitaxel injection 6 mg/mL, packaged in 30-mg/5 mL and 100 mg/16.7 mL multiple-dose vials. The drug is equivalent to New York-based Bristol-Myers Squibb Co.'s Taxol injection, an antitumor agent. It is approved for a variety of cancers. SuperGen hopes to complete a marketing and distribution licensing agreement during the first half of 2005.

• Symyx Technologies Inc., of Santa Barbara, Calif., signed a definitive agreement to acquire privately held IntelliChem Inc., of Bend, Ore. Symyx will pay about $28.9 million in cash to acquire all outstanding shares of IntelliChem, and will assume all the unvested options to purchase shares of IntelliChem common stock in exchange for about 50,000 options to purchase shares of Symyx common stock with an expected value of about $1.2 million. IntelliChem provides electronic lab notebooks for customers in the pharmaceutical, biotechnology and chemical industries. Symyx expects the transaction to close before the end of this year.

• Threshold Pharmaceuticals Inc., of South San Francisco, said that the FDA granted fast-track status to one of the company's lead drug candidates, glufosfamide for injection, to treat unresectable locally advanced or metastatic pancreatic adenocarcinoma previously treated with gemcitabine.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., began a Phase II trial of its lead product candidate, TPI-926, for an undisclosed central nervous system disease. The compound is a new formulation of an existing marketed product. The company advanced it from concept to Phase II in less than 18 months, it said, and expects results in the middle of next year. TransForm plans to commercialize it in the U.S., and collaborate with co-development partners abroad.