Aphton Corp., of Miami, said the SEC declared its registration statement on Form S-3 effective to sell 1.5 million shares of common stock, allowing Aphton to sell up to that amount from time to time. The proceeds of the financing will be used for general corporate purposes, including funding Aphton’s ongoing clinical trials and operations. Aphton has one Phase III study and three Phase II trials under way, developing products using its vaccine-like technology for neutralizing hormones that participate in gastrointestinal system and reproductive system cancer and noncancer diseases; and for the prevention of pregnancy. The company’s stock (NASDAQ:APHT) gained 64 cents Thursday to close at $13.01.
Cetek Corp., of Marlborough, Mass., signed an expanded research agreement with Cubist Pharmaceuticals Inc., of Lexington, Mass., that leverages both companies’ expertise in natural products drug discovery to identify novel compounds for the treatment of infectious diseases. Cetek will apply its technologies in natural extract screening and fractionation to identify novel compounds in Cubist’s NatChem library, which comprises compound extracts from naturally occurring microorganisms selected from a unique collection of rare and diverse fungi and actinomycetes. To date, Cubist’s small-molecule collaboration with Cetek has focused on synthetic compounds.
Chugai Pharmaceutical Co. Ltd. and its wholly owned subsidiary, Chugai Biopharmaceuticals Inc., of San Diego, said the FDA concluded that clinical trials may be reinitiated under the U.S. IND for the company’s agent GM-611. GM-611 is an agonist of motilin, a peptide hormone that plays a role in the contractile movement of the gastrointestinal tract. The compound is an erythromycin A derivative that is being studied to assess its effect on the recovery of gastronintestinal motility. Phase II trials with GM-611 were ongoing when Chugai noted possible serious adverse events in long-term carcinogenicity studies in rats.
Ciphergen Biosystems Inc., of Fremont, Calif., developed a new prototype of ProteinChip Arrays, which are expected to have particular utility for drug discovery applications. The ProteinChip SEND (Surface-Enhanced Neat Desorption) surfaces are modified with homogenous polymeric coatings that interact with bursts of focused lasered energy to allow the creation of ions, without unacceptable levels of chemical noise, for analysis via SEND detection using Ciphergen’s ProteinChip systems.
Curis Inc., of Cambridge, Mass., said findings from a study published in a recent issue of Kidney International indicate that Bone Morphogenic Protein-7 (also known as BMP-7 or OP-1) inhibits the expression of factors that promote inflammation and stimulates synthesis of other factors that promote blood flow within the kidney. BMP-7 is being developed by Curis for the treatment of kidney disease. It had previously demonstrated increased survival rates and improved recovery times in several animal models of acute and chronic kidney disease. The recent study provides evidence of a unique mechanism of action by which BMP-7 promotes recovery and reduces injury associated with kidney disorders, Curis said.
Deltagen Inc., of Redwood City, Calif., identified DT011M for the potential treatment of obesity and related diseases, such as diabetes. Deltagen plans to initiate a chemical screening program and compound development efforts during 2002. DT011M was discovered through the application of Deltagen’s target research and drug discovery program, which includes the company’s systems biology infrastructure, gene pathway analysis and pharmaceutically relevant disease challenge models.
Forbes Medi-Tech Inc., of Vancouver, British Columbia, initiated a Phase I trial for its novel cholesterol-lowering drug, FM-VP4. The trial is a randomized, double-blind, placebo-controlled, dose-ranging study designed to establish the safety of FM-VP4 and is being conducted at the Academic Medical Center, University of Amsterdam. Volunteers will be administered single doses of FM-VP4 ranging from 80 mg to 2000 mg beginning in mid-February. The treatment portion of the trial is expected to take up to 16 weeks, and results are expected to be available by mid-2002.
Gilead Sciences Inc., of Foster City, Calif., said its board approved a two-for-one split of the company’s outstanding common stock. Stockholders of record at the close of business on Feb. 14, 2002, will receive a stock dividend of one additional share of common stock for every share of common stock they own. The stock split will increase the number of total shares outstanding from about 96.7 million shares to roughly 193.4 million.
GlycoGenesys Inc., of Boston, raised about $5.1 million in net proceeds from institutional and accredited investors, selling 3,008,608 shares of common stock at $1.88 per share. It also issued warrants to purchase 903,243 shares at 1 cent per share and warrants to purchase 2,256,456 shares at an average weighted price per share of $2.25, all exercisable for five years. These funds are in addition to the $7.1 million in net proceeds received by the company in December. The Shemano Group, of San Francisco, acted as lead placement agent. GlycoGenesys develops and licenses pharmaceutical and agricultural products.
Guilford Pharmaceuticals Inc., of Baltimore, filed a submission in Europe seeking an expanded indication for its cancer therapy, Gliadel Wafer, for use during initial surgery for malignant glioma. Gliadel Wafer is approved in 24 countries for use during recurrent surgery for glioblastoma multiforme, and in Canada for use in both primary and recurrent surgery for glioblastoma multiforme. The European regulatory submission is based on favorable results from a randomized, double-blind, placebo-controlled Phase III trial that demonstrated a 30 percent improvement in survival rates in patients who received Gliadel Wafer therapy at the time of their initial diagnosis and surgery for malignant glioma.
Hemosol Inc., of Toronto, said the FDA gave Hemosol notice to proceed with a clinical trial of Hemolink, Hemosol’s oxygen therapeutic, in “re-do” cardiac bypass grafting surgery. The two-armed study will evaluate Hemolink in about 140 patients at more than 40 U.S. centers. All patients will undergo an intraoperative autologous donation procedure, with either Hemolink or allogeneic red blood cells administered in response to transfusion triggers. The study design is similar to Hemosol’s ongoing CABG study, which is now recruiting patients.
Idun Pharmaceuticals Inc., of San Diego, said the results of its Phase I trial of IDN-6556 indicate that it is safe and well tolerated. The study involved 50 normal adults. Evaluation of patients with mild hepatic impairment is ongoing. IDN-6556, a broad-spectrum caspase inhibitor, was administered in both single doses and for a week of therapy with various doses. The drug was well tolerated in all groups of subjects.
InterMune Inc., of Brisbane, Calif., relaunched Infergen (interferon alfacon-1) for the treatment of chronic hepatitis C infections. InterMune’s sales force will focus on hepatologists and support them in the use of Infergen in the treatment of hepatitis C. Infergen, also known as consensus interferon, is a bioengineered Type I interferon alfa and is FDA approved for the treatment of patients with chronic hepatitis C infections. InterMune recently reported positive interim results from a Phase IV clinical trial comparing the use of Infergen plus ribavirin to the use of interferon alfa-2b plus ribavirin (Rebetron) for the treatment of chronic hepatitis C infections.
LION bioscience AG, of Heidelberg, Germany, completed the acquisition of NetGenics Inc., of Cleveland, in exchange for LION American depository shares worth about $17.6 million, based on the price of the shares at the time of the Jan. 15 announcement. LION will issue an aggregate of about 1.12 million ADSs, with each ADS representing one LION ordinary share coming from authorized capital. The ADSs will be subject to a lock-up restriction for a 180-day period following completion of the acquisition. (See BioWorld Today, Jan. 16, 2002.)
Neurion Pharmaceuticals Inc., of Pasadena, Calif., with a mission to discover and optimize small-molecule drugs for the treatment of diseases and disorders of the central nervous system, said it received undisclosed seed funding from Convergent Ventures, of Los Angeles. Neurion is based on interdisciplinary research in chemistry and molecular neurobiology performed by its founding scientists, Dennis Dougherty and Henry Lester, both from the California Institute of Technology in Pasadena. Financial details were not provided.
Oncolytics Biotech Inc., of Calgary, Alberta, said it closed the secondary offering by Synsorb Biotech Inc., of about 1.5 million common shares of Oncolytics. After giving effect to this distribution, Synsorb owns approximately 24.6 percent of the 19.2 million common shares of Oncolytics presently outstanding. Oncolytics’ stock (NASDAQ:ONCY) closed Thursday at $2.27, up 37 cents, or 19.5 percent.
Orchid BioSciences Inc., of Princeton, N.J., granted Beckman Coulter Inc., of Fullerton, Calif., a nonexclusive license to use Orchid’s SNP-IT primer extension technology to develop SNP scoring products for the research market on multiple platforms. Beckman Coulter can produce and sell reagent kits, software and systems globally, incorporating Orchid’s SNP-IT technology for performing SNP analyses on DNA sequencers, microarray plates and flow cytometers. Orchid will receive an up-front payment and may see royalties on consumable product sales for each platform. Further financial details were not disclosed.
PPD Discovery, a subsidiary of Wilmington, N.C.-based PPD Inc., said it regained full rights to its HIV targets following a decision to conclude their January 2000 agreement by Agouron Pharmaceuticals Inc., which later was purchased by Pfizer Inc. PPD said it would further develop the molecular targets or seek relicensing opportunities. PPD will receive termination payments. The deal focused on identification of genes needed for HIV replication, using PPD’s high-throughput reverse genomics platform named GSX to select genetic suppressor elements. The original deal potentially was worth more than $30 million. PPD’s stock (NASDAQ:PPDI) gained $4.22, or 14.95 percent, to close at $32.45. (See BioWorld Today, Feb. 7, 2000.)
Proteom Ltd., of Cambridge, UK, completed a £3 million (US$4.2 million) funding round, with Avlar BioVentures Ltd. and Technomark Medical Ventures participating. This is the company’s first institutional investment round since it was founded in September 1999. Proteom is focused on designing peptide ligands used in developing next-generation therapeutics.
Rigel Pharmaceuticals Inc., of South San Francisco, said its oncology collaboration with Johnson & Johnson Pharmaceutical Research & Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J., resulted in the acceptance of two validated drug targets. The acceptance by J&J will result in a milestone payment to Rigel. The collaboration is based on the discovery of targets directed at the cell cycle. J&J provided research funding for an exclusive, worldwide royalty-bearing license to cell cycle-based products resulting from the collaboration. In early January, the companies announced that they extended the collaboration for two more years until December 2003.
SemBioSys Genetics Inc., of Calgary, Alberta, said it will receive a repayable C$2.4 million (US$1.5 million) investment from AVAC Ltd., of Calgary, to fully develop its technology platform to address the production of monoclonal antibodies. SemBioSys said it already has demonstrated the utility of its oleosin/oil body technology platform for the production of many types of proteins. With this funding, the company expects to expand its technology portfolio to include production of MAbs.
Sepracor Inc., of Marlborough, Mass., said the FDA approved Xopenex brand levalbuterol HCl inhalation solution for the treatment or prevention of bronchospasm in children ages 6 to 11 years old with reversible obstructive airway disease, such as asthma. Xopenex will be marketed for use in a nebulizer at dosage strengths of 0.31 mg and 0.63 mg for pediatric patients. It has been marketed for patients 12 years of age and older since May 1999. Results of a pediatric study were included in the new drug application and published in the December issue of The Journal of Allergy and Clinical Immunology.
SIGA Technologies Inc., of New York, said the results of two clinical trials for its live vector vaccine delivery system indicated it was well tolerated. Also, the organism used in the system was shown to be spontaneously eradicated or easily eradicated by conventional antibiotics. The company is using the patented technology for a number of vaccine applications, including its vaccine for group A streptococcal pharyngitis. SIGA’s stock (NASDAQ:SIGA) gained 60 cents Thursday, or 28.6 percent, to close at $2.70.
Viragen Inc., of Plantation, Fla., and Viragen International Inc. said their natural human alpha interferon was approved for sale in Mexico for patients with hairy-cell leukemia and chronic myelogenous leukemia who do not respond to recombinant interferon regimens. Mexican regulatory authorities approved an application filed by Viragen’s new strategic partner, Laboratorios Pisa, which has exclusive rights to distribute the natural interferon in Mexico. Applications will be filed with Mexico’s Ministry of Health to further broaden the drug’s indications, the company said.