Arena Pharmaceuticals Inc., of San Diego, reported results from the dosing phase of its Phase Ib trial of APD356, an orally administered small-molecule designed to regulate satiety, and perhaps metabolism, for the treatment of obesity. APD356 is a selective agonist of HT2C serotonin receptors, which are concentrated in the hypothalamus.
Array BioPharma Inc., of Boulder, Colo., plans to file a prospectus supplement with the SEC for an offering of 6 million shares under an existing shelf registration statement. Array plans to grant UBS Investment Bank, the sole book-running manager, an option to purchase up to 900,000 additional shares to cover overallotments. Legg Mason Wood Walker Inc., Piper Jaffray & Co. and Thomas Weisel Partners LLC are co-managers.
BioMarin Pharmaceutical Inc., of Novato, Calif., said it expects to begin a Phase III trial of Phenoptin (sapropterin hydrochloride) in phenylketonuria in the first quarter, based on guidance from a recent meeting with the FDA. As a primary efficacy endpoint, the six-week, multicenter, international, double-blind, placebo-controlled trial will measure the changes in blood phenylalanine levels in patients receiving Phenoptin compared to patients receiving placebo. It will enroll about 100 patients.
DOR BioPharma Inc., of Miami, said its academic partner, the University of Texas Southwestern Medical Center in Dallas, plans to proceed with Phase I testing of RiVax, a genetically engineered vaccine against ricin. The trial, the first ricin vaccine study in humans, is designed to test the product's safety and immunogenicity at doses that induce ricin-neutralizing antibodies.
Elan Corp. plc, of Dublin, Ireland, and its wholly owned subsidiary, Elan International Services Ltd., accepted for payment a total of about $351 million worth of Series B and C guaranteed notes issued by another wholly owned subsidiary, Elan Pharmaceutical Investments III Ltd. The amount includes about $317.4 million of notes previously accepted for payment and paid for. The notes were tendered and related consents delivered pursuant to the previously announced cash tender offer by Elan International to purchase up to $351 million of $390 million of notes and the related consent solicitation by Elan. Final settlement was expected to occur Tuesday, Elan said.
Generex Biotechnology Corp., of Toronto, said the diabetes investigator Jaime Guevara-Aguierre of the Institute of Endocrinology, Metabolism and Reproduction in Quito, Ecuador, published a research paper on Oral-lyn in the November/December 2004 edition of Diabetes/Metabolism Research and Reviews. The paper is a comparison of efficacy of the company's oral spray insulin, Oral-lyn, with subcutaneous insulin injection. The objective was to evaluate the metabolic effect of Oral-lyn, and the study results demonstrated that Oral-lyn can be used as meal insulin in place of mealtime insulin injections in subjects with Type II diabetes to regulate post-prandial glucose levels.
GenVec Inc., of Gaithersburg, Md., obtained an exclusive license from the National Institutes of Health in Bethesda, Md., covering worldwide rights to develop and commercialize products using pigment epithelium-derived factor protein for all ocular indications. The license expands the portfolio of patents previously licensed by GenVec, which includes the PEDF gene, and covers broad composition-of-matter rights and related methods of use.
Hemagen Diagnostics Inc., of Columbia, Md., extended its offer to exchange about $6.1 million in 8 percent senior subordinated secured convertible notes due 2005 for common stock and modified notes. The offer was scheduled to expire at midnight Nov. 29. The new expiration is midnight Dec. 3. To date, about $5.7 million, or 94 percent, of the notes have been deposited for exchange.
Human Genome Sciences Inc., of Rockville, Md., completed the enrollment and initial dosing of patients in a Phase II trial of HGS-ETR1 (agonistic human monoclonal antibody to TRAIL Receptor 1) in patients with advanced non-small-cell lung cancer. The trial is designed to evaluate the efficacy, safety and tolerability of HGS-ETR1 in patients with relapsed or refractory disease. HGS also said it began dosing patients in a Phase II trial of Albuferon (albumin-interferon alpha) in combination with ribavirin to evaluate the compound in patients with chronic hepatitis C who failed to respond to previous interferon alpha-based treatments. The study will enroll up to 100 patients in the U.S.
ImClone Systems Inc., of New York, began a Phase I trial of its fully human monoclonal antibody targeting the epidermal growth factor receptor, IMC-11F8, in patients with solid tumors. The study, which is designed to evaluate the safety and pharmacology of IMC-11F8 administered weekly or bi-weekly by intravenous infusion, is expected to enroll up to 40 patients.
Inpharmatica Ltd., of London, signed a nonexclusive Biopendium Online subscription with Shionogi & Co. Ltd., of Osaka, Japan. Biopendium is the advanced protein annotation component of PharmaCarta, Inpharmatica's gene-to-candidate platform. It provides sequence annotation for more than 150 organisms. Shionogi is the third Japanese subscriber this year.
Inyx Inc., of New York, reported positive results from a two-year stability study for a non-ozone-depleting hydrofluoroalkane propelled salbutamol metered-dose inhaler for treating asthma and other respiratory conditions. The inhaler uses Inyx's lipid-binding technology for enhancing the delivery of inhalation therapy drugs. Inyx plans to begin scale-up studies on the salbutamol HFA formulation in early 2005, and expects to file with U.S. and European regulatory authorities in 2006.
Kalypsys Inc., of San Diego, entered a technology transfer agreement with Los Alamos National Laboratory in New Mexico. Kalypsys will provide Los Alamos with its automated, high-throughput protein expression and purification technologies. Financial terms were not disclosed.
Myogen Inc., of Denver, completed the treatment phase of its two pivotal Phase III trials of low-dose enoximone capsules in patients with advanced chronic heart failure. The trials enrolled 1,854 patients at 211 trial sites in 16 countries. The company said the study has a sufficient number of primary endpoint events to fulfill the statistical power requirements for the first primary endpoint. Myogen expects to have all data collected by the middle of 2005.
The National Center for Research Resources, part of the National Institutes of Health in Bethesda, Md., said it would provide more than $1 million over three years to the University of North Carolina at Chapel Hill to further develop and make more widely available a Genome Fingerprint Scanning program. The tool allows researchers to match mass spectrometry data directly to raw, unannotated genetic sequences to identify proteins and locate new genes.
NPS Pharmaceuticals Inc., of Salt Lake City, said it will expand the scope of the new drug application it is preparing for Preos to treat osteoporosis by including efficacy and safety data from the second year of the PTH/alendronate (PaTH) study. The data provide insights into the possible use of Preos with alendronate, an anti-bone resorption compound. The company expects to submit the expanded application to the FDA by the end of February, and to European authorities in March.
Oragenics Inc., of Alachua, Fla., closed a private placement of unregistered units for $687,500 in proceeds. The placement consisted of 250,000 shares at $2.75 each, with each share receiving one-half of a warrant to purchase additional shares at $3.50 each. The company intends to use proceeds to support clinical development of its technologies and for general corporate purposes. Oragenics' lead product, an oral rise for the prevention of tooth decay, should enter clinical trials in early 2005. Oragenics said the FDA agreed to lift the clinical hold on its replacement therapy for the treatment of dental caries. The FDA had placed the original investigational new drug application on hold in May 2003, pending further review of the study design.
Pharmacopeia Drug Discovery Inc., of Princeton, N.J., reached a research milestone in its collaboration with Schering-Plough Corp., of Kenilworth, N.J., in the oncology therapeutic area. The milestone was triggered by Schering-Plough's decision to nominate a compound for full preclinical evaluation and resulted in a cash payment to Pharmacopeia. With the milestone, Pharmacopeia now has four partnered programs in preclinical development, as well as four in human clinical trials.
Pharmaxis Ltd., of Sydney, Australia, filed an investigational new drug application with the FDA to conduct a trial to support a marketing application for Aridol. The trial would be conducted at more than 10 sites in the U.S. and would recruit 130 subjects. The objective would be to determine sensitivity and specificity of Aridol with respect to clinical diagnosis of asthma. Aridol is an inhalable, dry powder that can be administered using a hand-held device.
Point Therapeutics Inc., of Boston, completed the first stage of its Phase II trial in Stage IIIB/IV non-small-cell lung cancer (NSCLC). The pre-established tumor response criteria were met, allowing the company to continue with the second stage of the study. It is evaluating the company's oral lead product candidate, talabostat (PT-100), in combination with Taxotere in patients with advanced NSCLC who have failed a prior platinum-containing regimen. Of the first 20 patients enrolled, a tumor reduction of at least 50 percent was observed in two patients.
Sanguine Corp., of Pasadena, Calif., said its product, PHER-02, was used to transport pancreas islet cells. The cells were transplanted into two humans at the University of Alberta in Edmonton. The trials are for the use of PHER-02 in the transportation and transplantation of pancreas islet cells. The pancreas islet cells are harvested from donors, then transported for use in human diabetics, whose islet cells are not producing insulin properly. PHER-02 is a synthetic red blood cell product.
Sanofi-Aventis Group, of Paris, said patients who received Eloxatin-based chemotherapy (FOLFOX4) plus Avastin (bevacizumab, Genentech Inc.) showed a statistically significant improvement in overall survival in a large randomized clinical study sponsored by the National Cancer Institute in Bethesda, Md. Preliminary results revealed a 26 percent reduction in the risk of death for patients receiving the combination compared to FOLFOX4 alone. Also, combination patients had a median overall survival of 12.5 months, compared to patients treated with FOLFOX4 alone, who had a median overall survival of 10.7 months. That statistically significant difference corresponds to a 17 percent improvement in median overall survival. Also, an affiliate of Sanofi-Aventis, Sanofi-Synthelabo Recherche, entered a partnership with Tripos Inc., of St. Louis. Sanofi-Synthelabo Recherche identified chemistry motifs that exhibit therapeutic potential in a range of target areas. Tripos will employ its chemistry approach to design and synthesize compounds that expand those areas.
Transgene SA, of Strasbourg, France, said it is conducting a new Phase II trial of its MVA-HPV-IL2 vaccine candidate in women diagnosed with precancerous lesions of the cervix, cervical intraepithelial neoplasia - CIN 2/3, related to type-16 human papillomavirus. Based on favorable data obtained from a previous Phase II trial that was conducted on CIN 2/3, the new study will evaluate MVA-HPV-IL2's efficacy after a six-month observation period, which will give patients longer time to mount an immune response. Enrollment is under way, and preliminary data are expected during the second half of next year.
YM BioSciences Inc., of Mississauga, Ontario, said the FDA granted orphan drug designation to the company's epidermal growth factor receptor monoclonal antibody TheraCIM hR3, for the treatment of glioma. TheraCIM hR3 is undergoing two Phase II trials in Europe and is expected to become a Phase III candidate in early 2005.