Aastrom Biosciences Inc., of Ann Arbor, Mich., was awarded by the Defense Advanced Research Projects Agency a $897,000 grant to research and development of a system to engineer human stem cells into an artificial immune system. The grant supports a first-phase initiative intended to establish the reliable differentiation of human stem cells into multiple immune functions within a 3-D culture system. The second phase of the program will focus on the continuation of first-phase technologies.
Access Oncology Inc., of New York, entered into a definitive license agreement with Zentaris AG, of Frankfurt, Germany, to develop Perifosine, an alkylphospholipid with antitumor properties, to treat cancer. Zentaris licensed to Access exclusive rights to develop and market Perifosine in the U.S., Canada and Mexico. Access will make up-front and milestone payments in excess of $18 million, pay royalties on net sales of Perifosine and fund all further development, including the completion of Phase II and III trials.
Agennix Inc., of Houston, and DSM Pharmaceutical Products, a business group of DSM NV, of Heerlen, the Netherlands, said a new manufacturing facility was opened on DSM's fermentation site in Capua, Italy. The facility is dedicated to the commercial production of pharmaceutical-grade recombinant human lactoferrin, which Agennix is developing. Lactoferrin is a protein found naturally in milk and other endocrine secretions that plays an essential role in stimulating the body's immune system.
Alteon Inc., of Ramsey, N.J., said it completed enrollment in its Phase II Diamond and Silver trials of ALT-711, and expects to complete enrollment in the Sapphire trial in the fourth quarter. ALT-711, Alteon's lead product, is an advanced glycosylation end-product crosslink breaker being tested in cardiovascular conditions, including systolic hypertension and diastolic heart failure. Data from the 20-patient Phase IIa Diamond trial in patients with diastolic heart failure are expected in the first quarter of 2003. Alteon has exceeded the minimum enrollment target of 180 patients in the Phase IIb Silver trial of patients with systolic hypertension and left-ventricular hypertrophy, with more than 260 patients. The company has currently enrolled over 355 patients of the 450 targeted for enrollment in the Phase IIb Sapphire trial of patients with systolic hypertension without left-ventricular hypertrophy. Data from the latter trials are expected during the middle of 2003.
Antex Biologics Inc., of Gaithersburg, Md., said its Tracvax vaccine against Chlamydia trachomatis provided protection against infection in preclinical studies. Antex said it identified a number of new Chlamydia proteins as potential C. trachomatis subunit vaccine candidates. Antex filed patent applications for several Chlamydia proteins, including the protein epitopes that form the basis of Tracvax, a recombinant subunit-based vaccine composed of outer membrane protein epitopes that are highly conserved among different Chlamydia strains.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., announced at the Bear Stearns Healthcare Conference discovery of two cancer drug candidates. One, AP23675, is designed to treat primary bone cancers and cancers that have spread to the bone. Ariad said it inhibits nutrient uptake in tumors, tumor cell growth and bone breakdown. The second candidate, AP23464, is designed to treat the progression and spread of solid tumors. The small-molecule candidate is a highly specific and potent inhibitor of the Src protein, whose enhanced expression is believed to play a large role in the spread of colon cancer, Ariad said.
Berna Biotech AG, of Bern, Switzerland, said it plans to cut between 60 and 65 employees by the end of 2004. While the moves will cost about CHF4 million (US$ 2.7 million), Berna said it expects the job cuts to save CHF5 million per year.
BioReliance Corp., of Rockville, Md., said it entered a laboratory services agreement with MedImmune Inc., of Gaithersburg, Md., in which BioReliance will perform a range of assays for certain MedImmune development-stage or commercial products for one year. BioReliance said it is improving its facilities, enhancing capabilities and adding staff to meet the needs of MedImmune.
Biosearch Italia SpA, of Milan, Italy, said it was awarded a EUR 6.5 million Innovation Technology Fund grant by the Italian Ministry of Productive Activities, to support preclinical and clinical development activities of its antibiotics and preparatory research into the processes for their production. Biosearch will use the funds mainly to boost output of key ingredients and will concentrate on strain improvement, fermentation development and downstream optimization related to its products undergoing clinical development, including ramoplanin, dalbavancin and BI-K0376. The money will be received over three years, with 40 percent of it nonrefundable and 60 percent repayable at a 1 percent interest rate.
BioSyntech Inc., of Laval, Quebec, announced the results of its preclinical efficacy studies using Pacligel (a sustained-release formulation of paclitaxel) on human breast tumor model (MCF-7) implanted orthotopically into immunocompromised SCID mice's mammary fat pad, as well as a distant subcutaneous location. BioSyntech said sustained delivery of paclitaxel (the active ingredient in Taxol) based on the BST-gel technology has advantages, including minimal systemic exposure of the agent. In a pilot breast cancer study in mice, Pacligel not only showed efficacy, but also was found to be safe at twice the lethal dose of free Taxol. The company said in vivo preclinical experiments will be set up to evaluate the potential of Pacligel to treat metastatic breast tumors and prostate cancer.
BTG plc, of West Conshohocken, Pa., said a potential new treatment for Type I and II diabetes that delivers insulin directly to the liver without causing a buildup of insulin in peripheral tissues, a major cause of side effects with current insulin therapies, was developed at Kings' College London. BTG is in discussions with potential licensees to further develop the technology. Specific analogues of the hepatoselective insulins have undergone preclinical and initial Phase I proof-of-concept testing in humans.
CancerVax Corp., of Carlsbad, Calif., said it secured a $6 million credit facility to fund equipment purchases and tenant and capital improvements for its new corporate headquarters, research and development laboratories, and manufacturing facilities. The credit financing was arranged with Western Technology Investment. The private company, which in August consolidated operations in Carlsbad, has as its lead product Canvaxin, a therapeutic cancer vaccine being evaluated for advanced-stage melanoma.
Cellzome AG, of Heidelberg, Germany, appointed David Brown president and CEO. He succeeds Charles Cohen, who will serve as chairman of Cellzome's supervisory board. Brown most recently served as global head of discovery at Roche Pharma in Basel, Switzerland.
Cel-Sci Corp., of Vienna, Va., signed a Cooperative Research and Development Agreement with the Naval Medical Research Center to jointly evaluate a newly discovered small peptide, derG, for protective and therapeutic efficacy for malaria. The peptide induced responses that were 100 percent effective against malaria in a mouse model, the company said.
Connecticut Gov. John Rowland said that a pilot program will begin Jan. 1 to assist the growth of emerging bioscience companies based in his state. The program will provide Connecticut banks with a 30 percent loan guarantee for small bioscience companies requesting financing for machinery and equipment. Rowland said that Connecticut-based bioscience research and development investment in 2001 totaled $3.6 billion, an 18 percent increase over 2000. Through the program, the state's Office of BioScience will provide banks with a better understanding of companies' specific activities and serve as an additional resource for financing.
Curis Inc., of Cambridge, Mass., reported publication in the Sept. 18, 2002, issue of Neuroscience of findings that demonstrate the therapeutic potential of the Sonic Hedgehog protein being developed for Parkinson's disease and other nervous system disorders. The study showed treatment in a preclinical Parkinson's model reduced behavioral impairments and neural loss.
Esperion Therapeutics Inc., of Ann Arbor, Mich., initiated a double-blind, placebo-controlled, dose-escalating Phase I trial of its RLT Peptide product, ETC-642, in up to 20 patients with atherosclerosis. The study, in addition to safety and tolerability, will evaluate pharmacokinetics and lipid effects of a single intravenous infusion. ETC-642 is designed to mimic the effects of apolipoprotein A-I to promote cholesterol removal and enhance reverse lipid transport.
Genomatica Inc., of San Diego, entered into a research agreement with The Dow Chemical Co., of Midland, Mich., to use Genomatica's SimPheny modeling platform to develop an in silico metabolic model for Dow's use in microbial metabolism and bioprocess modeling. The in silico model also is designed to allow Dow to predict the effect of genetic changes made to a microorganism before running experiments and provide a focal point for the integration of high-throughput experimental data. Specific financial terms were not disclosed, but include research support and milestone payments.
GPC Biotech AG, of Martinsried, Germany, said its management and supervisory boards approved corporate governance principles, making GPC one of the first German public corporations to adopt and publish them based on the German Corporate Governance Code published in February. The principles help to ensure that GPC is managed and monitored in a responsible and value-driven manner. They include the protection of shareholders' rights, comprehensive disclosure and transparency requirements, and rules governing conflicts of interest and own-account transactions. The principles strengthen GPC's prior corporate governance principles, adopted in November.
Harvard Bioscience Inc., of Holliston, Mass., updated financial guidance for 2002 due to a continued slower-than-expected adoption of its Copas technology and a third-quarter weakness in its international business. Harvard said it continues to expect third-quarter revenues to grow between 15 percent and 20 percent compared to last year's third quarter, but expects third-quarter pro-forma earnings per share to be flat vs. last year. The company's stock (NASDAQ:HBIO) fell $2.53 Wednesday, or 53 percent, to close at $2.25.
Inhibitex Inc., of Atlanta, entered into a research collaboration agreement with the Biopharmaceutical Manufacturing Technology Center in Singapore. They will jointly develop production cell lines and a cGMP manufacturing process for humanized monoclonal antibodies. The collaboration will merge certain technologies and know-how in an effort to more rapidly bring products to the market. Financial terms were not disclosed.
Invenux Inc., of Denver, said it was awarded a Phase I Small Business Innovation Research grant of $85,000 by the National Institute of Allergy and Infectious Diseases to develop and validate ADME predictive techniques that will be incorporated into its Evolution Chemistry discovery technology. The techniques will be used to select sets of compounds with predefined ADME characteristics from small-molecule libraries.
Isolagen Inc., of Houston, announced the opening of its London cellular laboratory, which has begun the commercialization of the Isolagen Process for the European marketplace. Isolagen develops autologous cellular technology with applications in cosmetic dermatology, cosmetic surgery, periodontal disease, reconstructive dentistry and other health-related markets.
Large Scale Biology Corp., of Vacaville, Calif., filed with the FDA an orphan drug application related to its plant-produced human alpha-galactosidase A for enzyme replacement therapy. Large Scale Biology said the molecule might effectively treat Fabry's disease, a multisystemic, lipid storage disorder caused by a deficiency of that lysosomal enzyme.
Maxim Pharmaceuticals Inc., of San Diego, began a randomized, blinded clinical study of MX8899 topical gel to treat radiation-induced dermatitis, a side effect of head and neck radiation therapy used to treat various cancers. The trial will enroll up to 30 patients, each receiving bilateral neck radiotherapy for head and neck squamous cell carcinoma. Its objectives are to evaluate the safety, tolerability and biological activity of the gel for the treatment of radiation-induced dermatitis in patients with squamous cell carcinoma of the head and neck.
Merik Bioscience Inc., of Durham, N.C., said Chairman Clint "Skip" Dederick Jr. was named CEO. Dederick brings 30 years of experience in the pharmaceutical and biotechnology industries to the company, which is poised to move into the clinic with its novel immunotherapy cancer vaccines.
Odlander Fredrikson Group, of Stockholm, Sweden, and Lausanne, Switzerland, said HealthCap IV closed a fund with committed capital of SEK3 billion (US$322 million). HealthCap IV is a multistage venture capital fund investing in the medical sector. HealthCap invests internationally, with a focus on the Nordic region and Western Europe. The three previous HealthCap funds will continue to make follow-on investments in existing portfolio companies. The Odlander Fredrikson Group is the exclusive investment adviser to the fund.
Perlegen Sciences Inc., of Mountain View, Calif., entered into a collaboration with GlaxoSmithKline plc, of London, to use whole-genome single nucleotide polymorphism scanning to identify genetic markers of drug response. The goal is to identify in a limited number of patients a pattern of markers that may be associated with a pharmacogenomic response. Perlegen uses high-density microarray DNA chips to rapidly sequence DNA. More than 1 million SNPs will be scanned. Financial terms of the deal were not disclosed.
Pharmasset Inc., of Tucker, Ga., was awarded by the National Institutes of Health in Bethesda, Md., a $214,000 Small Business Innovation Research grant to fund research on anti-poxvirus nucleosides. Pharmasset said it aims to build on its lead pyrimidine nucleoside analogues that exhibit antiviral activity against smallpox, vaccinia and cowpox.
Progen Industries Ltd., of Brisbane, Australia, entered into an exclusive agreement with Unisearch, the commercialization company of the University of New South Wales, to license and develop a newly patented cancer therapy. The candidate, PI-166, is in late-stage preclinical development and has shown anticancer activity in preliminary laboratory and animal studies. Progen will fund additional R&D, including early human trials, to further validate the therapy.
Rigel Pharmaceuticals Inc., of South San Francisco, began in the UK Phase I testing of its first product, a drug to treat allergic rhinitis. The compound, R112, is designed to inhibit the activation of mast cells, whose activation is one of the earliest steps in beginning an inflammatory response in allergy and asthma.
Senesco Technologies Inc., of New Brunswick, N.J., signed a development and license agreement with Cal/West Seeds, of Woodland, Calif., which will enable the companies to incorporate Senesco's technology into the enhanced proprietary alfalfa varieties being developed by Cal/West. The agreement includes options for the development of various other forage crops. Financial terms were not disclosed.
Sonus Pharmaceuticals Inc., of Bothell, Wash., reported efficacy results from the dose-escalation stage of four Phase II studies of Tocosol Paclitaxel in non-small-cell lung, bladder, ovarian and colorectal cancers. Sonus said results to date demonstrate objective antitumor responses in all four cancers and a disease control rate (partial responses plus stable disease) ranging from 37 percent to 89 percent. The product is a proprietary formulation of the active ingredient in Taxol. Seventy-three patients were evaluable for efficacy. The company said the product can be administered in 15 minutes or less, compared to a three-hour infusion for Taxol. It plans to continue enrolling patients in all four studies and to initiate additional trials. Sonus' stock (NASDAQ:SNUS) gained 19 cents Wednesday, or 9.5 percent, to close at $2.20.
The Speedel Group, of Basel, Switzerland, said Novartis AG, also of Basel, exercised its call-back option for Aliskiren (SPP100) with the goal of further developing the compound in order to gain regulatory approval and commercialization in hypertension. Aliskiren is an orally active rennin inhibitor being developed for cardiovascular indications. Speedel in-licensed Aliskiren from Novartis in 1999 and conducted fast-track development through Phase I and II.
Triangle Pharmaceuticals Inc., of Durham, N.C., settled patent disputes involving its drug candidate, amdoxovir, a purine nucleoside analogue to treat HIV licensed from Emory University in Atlanta and the University of Georgia Research Foundation. Emory and the UGA foundation received an exclusive license to patent rights covering amdoxovir belonging to Shire Pharmaceuticals Group plc, of Andover, UK. Emory and the UGA foundation granted Triangle an exclusive sublicense to those rights. In exchange, Triangle will pay Shire a royalty on future amdoxovir sales.