Acusphere Inc., of Watertown, Mass., reported results from a Phase I study of its asthma drug candidate, AI-SR, which demonstrated sustained release of the drug relative to the commercially available inhaled formulation. AI-SR is Acusphere's dry powder sustained-release microparticle formulation of a marketed asthma drug. It is designed to slowly release the drug locally in the lungs and thereby reduce the multidosing daily regimen to a once-per-day treatment. Pharmacokinetic analysis from the study demonstrated sustained levels of the drug in the blood over at least 12 hours.
ArQule Inc., of Woburn, Mass., achieved a milestone, triggering a payment from Wyeth, of Madison, N.J. Wyeth nominated a compound targeted in women's health to its development pipeline whose discovery was facilitated through the collaborative Directed Array program with ArQule. ArQule and Wyeth began a five-year, $28 million collaboration in 1997. Financial terms relating to the milestone were not disclosed. (See BioWorld Today, July 11, 1997.)
BioFocus plc, of Sittingbourne, UK, and Xention Discovery Ltd., of Cambridge, UK, entered a two-year ion channel drug discovery program. The companies aim to develop enhanced drug candidates that selectively interact with an ion channel target for the treatment of atrial fibrillation. BioFocus will exclusively license to Xention a range of compounds already identified by BioFocus as potential ion channel modulators. Xention will exploit its AutoPatch technology for further compound screening and BioFocus will provide ongoing medicinal and computational chemistry expertise for hit-to-lead optimization.
BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., initiated a Phase II trial of LibiGel (testosterone gel) for the treatment of female sexual dysfunction. The trial is a double-blind, placebo-controlled study that will enroll about 120 patients to determine the effect of LibiGel on women's sexual desire and activity.
Bio-Technology General Corp., of New York, said that late last Friday, KPMG informed BTG that it will not continue its engagement as BTG's auditors. KPMG has indicated to BTG that it is not withdrawing its Sept. 20, 2002, report on its reaudit of 1999, 2000 and 2001. The company said it will appoint new auditors in the coming days.
Celera Diagnostics, of Alameda, Calif., entered a collaboration with Bristol-Myers Squibb Co., of New York, to study genes that may be useful in the diagnosis and treatment of cardiovascular disease and diabetes. BMS will provide clinical samples and data to Celera, which will conduct studies to correlate genetic variability with cardiovascular disease and diabetes. BMS will receive exclusive rights to develop and market resulting drugs. Celera will retain exclusive rights to develop and market diagnostic products. Financial terms were not disclosed.
Cell Pathways Inc., of Horsham, Pa., said it reduced its work force from 81 employees to 61 employees and is cutting planned expenditures in earlier-stage programs. It will focus on the development of Aptosyn (exisulind) and CP461. Aptosyn in combination with Taxotere is being tested in a Phase III in non-small-cell lung cancer. CP461 is in Phase II trials in oncology and inflammatory bowel disease. Cell Pathways' stock (NASDAQ:CLPA) rose 3 cents Monday to close at 63 cents.
ConjuChem Inc., of Montreal, said that results from its Phase I trial of DAC:GLP-1 for the treatment of Type II diabetes are now expected in the first half of 2003, as a result of the need to manufacture a reformulated clinical batch of the compound to complete the trial. Results initially were expected to be ready in late 2002. ConjuChem's stock (TSX:CJC) fell C9 cent Monday, or 15.5 percent, to close at C49 cents.
Etiologics Ltd., of Oxford, UK, was established in the UK by the Medical Research Council in London and through the initial venture capital backing of £3.5 million (US$5.25 million) from MVM Ltd., of London, and ABN AMRO Capital. Etiologics will commercialize research and technology developed by the MRC Mammalian Genetics Unit at Harwell, UK, through the discovery and validation of therapeutic targets for its own account and in collaboration with pharmaceutical and biotechnology partners. Etiologics was spun out of the MRC Mammalian Genetics Unit, which studies the underlying genetic causes and progression of human disease.
Gene Logic Inc., of Gaithersburg, Md., said IDEC Pharmaceuticals Corp., of San Diego, extended its subscription to the GeneExpress Oncology DataSuite for use in IDEC's drug discovery and development efforts focused on cancer therapies. IDEC's researchers will continue to use the suite's genomic and clinical information on normal and diseased human tissues to support their internal genomics-driven target identification and validation initiatives.
GenPhar Inc., of Mount Pleasant, S.C., reported preliminary results from animal trials of its vaccine for Marburg virus, a highly lethal hemorrhagic virus similar to Ebola. Tests were conducted by the U.S. Army Medical Research Institute of Infectious Diseases, which identified the disease as a potential biowarfare threat. The vaccine proved to be 100 percent effective in protecting experimental animals against the disease. The vaccine is based on GenPhar's vaccine platform, which the company said can be adapted for HIV, hepatitis B and C and other agents causing infectious diseases.
Icagen Inc., of Research Triangle Park, N.C., received notification from the FDA that ICA-17043, now in Phase II trials for the treatment of sickle-cell anemia, received fast-track designation. ICA-17043 targets a specific ion channel, known as the Gardos channel, located on the membrane of red blood cells.
Idun Pharmaceuticals Inc., of San Diego, said its technical founder and chairman of its scientific board, Robert Horvitz, was awarded the Nobel Prize in Physiology or Medicine 2002. Horvitz holds one-third of the prize, and shares it with Sydney Brenner of The Molecular Sciences Institute in Berkeley, Calif., and Sir John Sulston, of The Wellcome Trust Sanger Institute in Cambridge, UK. Horvitz, also a grantee of the National Institutes of Health in Bethesda, Md., was noted for deciphering cell death genes, which shed light on AIDS, neurodegenerative diseases, stroke and cancer.
InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said the company and its noteholders amended InKine's $10 million June 2003 convertible notes. Noteholders have agreed to remove the requirement that the company's stock be listed on the Nasdaq National Market. In connection with the restructuring agreement, the company secured the notes, issued additional warrants and increased the semiannual coupon. InKine is focused on the diagnosis and treatment of cancer and autoimmune diseases.
Insmed Inc., of Richmond, Va., said Pharmacia Corp., of Peapack, N.J., granted Insmed an exclusive license to its portfolio of regulatory filings pertaining to insulin-like growth factor-1 for the treatment of growth hormone insensitivity syndrome. The filings were used previously to obtain marketing approval in several European territories and also supported an investigational new drug application to the FDA. Insmed plans to use the information to expedite the development and approval of SomatoKine, a recombinant form of human insulin-like growth factor-1 and its regulatory binding protein, IGFBP-3, for the condition.
InterMune Inc., of Brisbane, Calif., and Maxygen Holdings Ltd., a wholly owned subsidiary of Maxygen Inc., of Redwood City, Calif., reported they have made progress in their alliance to develop a next-generation version of Actimmune (interferon gamma 1-b) that can be taken once weekly rather than three times a week. Maxygen has received a $1 million milestone payment from InterMune for achieving drug performance criteria established by InterMune. Maxygen developed a series of preclinical candidates that had improved pharmacokinetic properties in animal models.
OrthoLogic Corp., of Tempe, Ariz., reported results of its Phase I/II trial of its orthobiologic product, Chrysalin, at the 57th annual meeting of the American Society for Surgery of the Hand held Oct. 3-5 in Phoenix. The trial was a randomized, double-blind, placebo-controlled study of 90 patients in seven clinical centers to evaluate the safety and efficacy of Chrysalin. The results showed no drug-related adverse events for Chrysalin patients relative to those treated with placebo.
Seattle Genetics Inc., of Bothell, Wash., entered into a relationship with Albany Molecular Research Inc., of Albany, N.Y., for the development and manufacture of SGI's drug-linker systems. The systems are composed of cell-killing drugs and stable linkers and are the primary component of Seattle Genetics' antibody-drug conjugate (ADC) technology platform. Albany Molecular will perform process development, scale-up and GLP and cGMP manufacturing of certain drug-linker systems. The manufactured material will be used by Seattle Genetics and its collaborators for research, development and clinical studies of ADC product candidates.
SIGA Technologies Inc., of New York, received about $1 million from a private placement of units consisting of an aggregate of 1,037,500 shares and warrants to purchase 518,750 shares of stock at an exercise price of $2.25 per share, with a group of private investors. The offering yielded net proceeds of about $935,000 to SIGA, which is identifying and developing anti-infective agents based on its research in the field of bacterial surface proteins.
Stressgen Biotechnologies Corp., of Paris, presented data showing its lead product, HspE7, achieved complete responses of genital warts among a clinically significant percentage of patients for up to 24 months. New data were presented at the 20th International Papillomavirus conference from three sets of patients treated with HspE7. Subgroup analysis showed that women treated with HspE7 at six months achieved a 62 percent complete response rate compared to 20 percent in the placebo group. In the same study, men with anal and perianal warts treated with the drug achieved a 42 percent complete response rate vs. 25 percent for the placebo group. New follow-up data from Stressgen's retrospective evaluation of anal dsyplasia patients with concomitant anorectal warts showed complete responses in eight out of 10 patients who had been followed for 24 months.
SurroMed Inc., of Mountain View, Calif., was awarded a Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The funding will support application of SurroMed's integrated biological marker discovery technologies to the identification of biomarkers to facilitate the early and objective diagnosis of Alzheimer's disease.
Targacept Inc., of Winston-Salem, N.C., completed Phase I trials to evaluate the tolerability, safety and preliminary pharmacokinetics of TC-2403-12, a neuronal nicotinic receptor agonist derived from Targacept's library of compounds. The company conducted the trials with Dr. Falk Pharma GmbH, of Freiburg, Germany. Targacept and Falk formed an alliance in 2001 to develop a new class of drugs to treat ulcerative colitis.
Telik Inc., of South San Francisco, initiated the first in a planned series of clinical trials of TLK286 in combination with standard chemotherapy as part of a comprehensive development program for the drug. The combination of TLK286 and docetaxel will be evaluated in patients with advanced non-small-cell lung cancer who have failed prior platinum-based chemotherapy.
TransForm Pharmaceuticals Inc., of Lexington, Mass., acquired an exclusive license from Massachusetts Institute of Technology to strengthen and broaden its position in high-throughput pharmaceutical form and formulation. MIT provided TransForm with access to technology that will enable automated microscale dispensing of dry powder materials.
Versicor Inc., of Fremont, Calif., completed enrollment of 600 patients in a pivotal Phase III study of its lead investigational product, anidulafungin, for the treatment of esophageal candidiasis. Versicor expects to report results of the Phase III trial in the first quarter of 2003. The company also completed enrollment of a Phase II study with the antifungal agent for the treatment of invasive candidiasis/candidemia. The company initiated the trial in March 2001. (See BioWorld Today, March 23, 2001.)
ZymoGenetics Inc., of Seattle, and Alexandria Real Estate Equities Inc., completed a sale leaseback transaction involving the ZymoGenetics headquarters buildings. The three buildings, totaling about 158,000 rentable square feet, were acquired by Alexandria for $52 million. Simultaneously, ZymoGenetics agreed to lease the buildings from Alexandria for 15 years, subject to further renewal options.