Alfacell Corp., of Bloomfield, N.J., updated its clinical trial program for its product, Onconase. The company said that it has a Phase III program under way at 33 centers in the U.S. with Onconase as a single agent, and a combination study with Onconase and doxorubicin in more than 30 centers in the U.S. and Europe. Onconase is designed to treat unresectable malignant mesothelioma.
Amarin Corp. plc, of London, said Elan International Services Ltd., a subsidiary of Elan Corp. plc, of Dublin, Ireland, converted approximately 2.13 million shares of Amarin convertible preference stock into about 21.29 million shares of Amarin ordinary stock (equivalent to approximately 2.13 million American depositary shares). This conversion is in accordance with the terms of the subscription agreement entered into by Elan and Amarin in November 1999. Elan now owns approximately 27 percent of Amarin’s undiluted shares outstanding.
Amgen Inc., of Thousand Oaks, Calif., presented a check for $145,000 to the Fitzsimons Redevelopment Authority (FRA) in Aurora, Colo. David Bengston, head of Amgen’s Colorado operations, presented the check in support of Fitzsimons developing the former Fitzsimons Army Medical Center in Aurora into a biotech entrepreneurs hub. The funds will aid the FRA’s work in launching and growing new biotechnology ventures.
Argenta Discovery Ltd., of Harlow, UK, identified two potential lead candidate series during a six-month project with Aventis Pharma AG, of Frankfurt, Germany. Argenta optimized the necessary primary and secondary functional assays, predicted the binding of the leads to the protein’s 3-dimensional structure using computer-aided drug design techniques and synthesized over 150 compounds. Aventis will further develop the two lead series into clinical candidates for the treatment of central nervous system disorders in its laboratories in Bridgewater, N.J.
BioSyntech Inc., of Laval, Quebec, received a formal commitment for a C$2.5 million (US$1.6 million) debt financing from BDC Venture Capital, a division of the Business Development Bank of Canada. Additionally, BioSyntech said it is in advanced stages of securing an additional revolving line of credit of C$1.5 million with a major Canadian chartered bank. This revolving line of credit will be used if needed to help launch products in the European market.
Celeres Pharmaceuticals Inc., of Tustin, Calif., closed its Series A round of financing at $500,000. The company said it would seek further investments through subsequent rounds. Celeres uses pharmaceutics and pharmacology for developing drug products for primary and supportive therapy for cancer.
CellFactors plc, of Cambridge, UK, released a library of immortalized human neural cell lines derived from the brain and spinal cord. The company patented a novel method of producing stable partially differentiated human cells for therapeutic purposes. CellFactors said it plans to supply tissue-specific neural-derived cell lines for a range of pharmaceutical applications.
Copernicus Therapeutics Inc., of Cleveland, said the first person in a 12-patient study received a nonviral gene transfer vector in an effort to develop gene therapy for cystic fibrosis. The study aims to use gene transfer technologies to provide a normal copy of the CF gene to correct the underlying defect of the disease. The study is being done in collaboration with University Hospitals of Cleveland, Case Western Reserve University School of Medicine and Cystic Fibrosis Foundation Therapeutics Inc., a nonprofit affiliate of the Cystic Fibrosis Foundation.
Cortex Pharmaceuticals Inc., of Irvine, Calif., and Les Laboratoires Servier, of Paris, said that the first of 31 sites across six countries began enrolling patients with mild cognitive impairment (MCI) to study Ampakine CX516. The cross-national trial will evaluate the efficacy and safety of Ampakine CX516 in approximately 160 patients with MCI between the ages of 55 and 85. The remaining sites eight in the U.S., 22 across France, Belgium, Great Britain, Sweden and the Netherlands will start enrolling patients over the next several weeks so the study can be completed in 12 months.
Cytovax Biotechnologies Inc., of Edmonton, Alberta, began a Phase I trial of its lead product, Cytovaxine, a peptide vaccine for the prevention of infections caused by Pseudomonas aeruginosa, a leading cause of hospital-acquired infections. The study, which will be randomized and double blinded, is designed primarily to investigate the safety of Cytovaxine in 35 normal, healthy subjects. Patients will receive one of three escalating dose levels of Cytovaxine 15 micrograms, 30 micrograms or 60 micrograms or a control vaccine. A zero, six-week and five-month injection schedule will be employed. A six-week safety evaluation prior to dose escalation also will be included.
Digene Corp., of Gaithersburg, Md., said the U.S. Army is adopting testing for human papillomavirus using Digene’s Hybrid Capture 2 HPV DNA Test in its worldwide cervical cancer-screening program. The Army conducts approximately 350,000 to 400,000 Pap tests annually in its medical treatment facilities worldwide serving military personnel and their dependents.
EGeen International Corp., of Redwood City, Calif., completed a $2 million private placement financing led by the SEAF CEE Growth Fund, of Washington, and The Baltics Small Equity Fund, of Tallinn, Estonia. EGeen has exclusive commercial rights to information from the Estonian Gene Bank project, a national effort sponsored by the northern European country’s government with the objective of gathering DNA samples from a significant portion of the population. EGeen will use this database for drug and diagnostic target discovery and personalized medicine applications.
Exactech Inc., of Gainesville, Fla., and Genzyme Biosurgery, a division of Genzyme Corp., of Cambridge, Mass., entered into an agreement combining Exactech’s use of human-derived bone materials with Genzyme Biosurgery’s synthetic biomaterials to develop new polymer-based materials that support the growth of new bone. Genzyme Biosurgery provided Exactech an exclusive worldwide license to use its Focal synthetic bioabsorbable polymer technologies in certain bone grafting applications in exchange for unspecified payments on future products. Genzyme Biosurgery will supply materials and polymer expertise to Exactech, which will be responsible for manufacturing and distributing resulting products.
Genoptera LLC, a joint crop protection venture between Bayer AG, of Leverkusen, Germany, and Exelixis Inc., of South San Francisco, completed a genome sequencing project of a lepidopteran species, Heliothis virescens, an insect pest commonly known as the tobacco budworm. The sequencing breakthrough provides, for the first time, nearly complete analysis of the genes of a lepidopteran species. The sequencing feat has the potential to accelerate and streamline the development of safe, more innovative insecticides.
Genzyme Molecular Oncology, a division of Genzyme Corp., of Cambridge, Mass., signed an exclusive patent license for use of a gene believed to be implicated in metastatic colon cancer. The phosphatase enzyme, called PRL-3, was discovered by Genzyme’s research partners at Johns Hopkins University in Baltimore using the Serial Analysis of Gene Expression technology. Genzyme Molecular will begin conducting research and drug development in collaboration with the team at Johns Hopkins to learn how metastasis believed to be associated with PRL-3 could be blocked.
Immtech International Inc., of Vernon Hills, Ill., began a Phase II trial of DB289 in South Africa for the treatment of Pneumocystis carinii pneumonia (PCP) in HIV/AIDS patients. In the safety and efficacy trial, DB289 will be given orally for 14 days to approximately 40 patients, who will be evaluated for elimination of the fungus and improved respiration. A separate Phase II trial being conducted with DB289 was initiated in the Democratic Republic of Congo to treat another infectious disease, African sleeping sickness.
Indevus Pharmaceuticals Inc., of Lexington, Mass., a company formerly named Interneuron Pharmaceuticals Inc., is now trading on the Nasdaq Stock Market under the new ticker symbol, IDEV. Its former symbol was IPIC. The company said the new name better describes a mission of product acquisition, an evolution away from a neurological focus and toward the in-licensing and development of product candidates for indications that include anxiety disorders, overactive bladder, inflammatory bowel disease and the prevention of HIV transmission.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it implemented a stock trading program for Isis’ board, corporate executive officers and other insiders. Under the rule, when there is no material nonpublic information available, corporate insiders can establish plans that permit pre-arranged future sales of their securities. Isis is using its RNA knowledge to discover and develop therapeutic drugs.
LifeSpan BioSciences Inc., of Seattle, launched its subscription DrugTarget Database, billed as a comprehensive resource on the expression and localization of proteins at the cellular level. The database combines immunohistochemistry data, obtained by using specific antibodies to determine protein localization in normal and diseased human tissues, with manually curated data covering more than 2,000 human genes from eight gene families, which include G protein-coupled receptors, ion channels, kinases, nuclear receptors, phosphatases, phosphodiesterases, transporters and proteases.
MetriGenix Inc., of Gaithersburg, Md., formed a research agreement with Temple University to co-develop proteomic chips in the area of cardiovascular disease. The chips will be targeted for use by pharmaceutical, biotechnology and academic researchers focused on defining the cellular and molecular basis for cardiovascular diseases, including congestive heart failure. Researchers at Temple will provide a selection of proteins based on their relevance to congestive heart failure, both from research conducted by Temple researchers and from a review of literature.
MorphoSys AG, of Martinsried, Germany, delivered several antibodies against a cancer target molecule to ImmunoGen Inc., of Cambridge, Mass., triggering a milestone payment to MorphoSys. As part of the September 2000 agreement, MorphoSys will receive development-related milestone payments and royalties on marketed products emerging from the collaboration. The companies are collaborating in developing a fully human antibody against an ImmunoGen-provided cell-surface target associated with various forms of cancer. Additionally, since June, ImmunoGen has had access to the MorphoSys HuCAL antibody library for use in its internal research programs.
Myriad Genetics Inc., of Salt Lake City, formed a research collaboration with Pioneer Hi-Bred International Inc., of Des Moines, Iowa, a subsidiary of DuPont. Myriad will apply its high-speed genomic sequencing capability and bioinformatics experience to deliver molecular genetic information to Pioneer. Myriad stands to gain $24 million over two years. The collaboration will seek to enhance the development of seed products. Myriad’s most advanced product, Flurizan, is in clinical trials and Myriad expects to initiate a Phase II trial in colonic polyps later this year.
Nastech Pharmaceutical Co. Inc., of Hauppauge, N.Y., received a $2 million development milestone payment from Pharmacia Corp., of Peapack, N.J. In February, the companies entered into an exclusive worldwide agreement for the development and commercialization of intranasal apomorphine for the treatment of male and female sexual dysfunction. Nastech has received $10 million to date, consisting of $5 million in non-equity, non-creditable payments and a $5 million equity investment at $20 per share. The agreement calls for additional milestone payments of up to $43 million, cost reimbursements of up to $3.4 million, royalty payments upon approval, and transfer payments from Pharmacia for manufacturing intranasal apomorphine.
Neuralstem Inc., of Gaithersburg, Md., was awarded a Defense Advanced Research Projects Agency contract that will provide $2.4 million in funding in 2002 and 2003. Neuralstem will apply its stem cell technology to the discovery of drugs that may enhance cognitive ability and extend the ability to perform cognitive tasks during extended periods of sleep deprivation. The funding is for the first phase of the program. Neuralstem is eligible for a second phase award of $7 million for research done from 2003 to 2006. Neuralstem focuses on commercializing central nervous system stem cell technology and human neurons derived from its central nervous stem cells.
Northwest Biotherapeutics Inc., of Bothell, Wash., said it will present additional favorable results from the Phase I/II late-stage prostate cancer evaluation of its dendritic cell-based immunotherapy, DCVax-Prostate. The data will be presented Sunday at the 93rd Annual American Association for Cancer Research Meeting in San Francisco. Northwest said it saw overall stabilization of disease in 54.8 percent (17 of 31) of patients in the trial.
Nymox Pharmaceutical Corp., of Maywood, N.J., completed a private placement with existing shareholders totaling $819,000, priced at $4.20 per share. The funds are for general corporate purposes. Last month, Nymox said that its AlzheimAlert test is being used in a large aging study at Tufts University, in Boston. Nymox also entered a licensing agreement with Brown University in Providence, R.I.
Pennsylvania’s Life Sciences Greenhouse, spread among Southeast, Southwest and Central Pennsylvania, was granted $100 million to help biotechnology expand in the area. The Greenhouse said it is expected to create 4,400 jobs, attract or create 100 biotechnology companies and leverage more than $150 million in private capital during the next five years.
Regeneration Technologies Inc., of Alachua, Fla., said it was advised by its principal commercial lender that as a result of its results of operations for the year ended Dec. 31, it does not meet certain financial ratio covenants that it is required to meet under its existing credit facilities. RTI has an agreement in principle with its lender for a waiver of this noncompliance and the related covenants, in exchange for RTI’s commitment to repay amounts that it owes within the next six months. This agreement is subject to definitive documentation, which was not completed prior to the time RTI’s Annual Report on 10-K was required to be filed. RTI expects to finalize this documentation with its lender shortly and to file its 10-K within 15 days.
Replicon Technologies Inc., of Danville, Calif., said it received $3 million in financing from Johnson & Johnson Development Corp., giving Replicon a total of $5.4 million raised to date. It is seeking another $2.5 million to close this Series A round. Replicon focuses on developing therapeutic applications of replicons for human tumors.
Sanguine Corp., of Pasadena, Calif., signed a license agreement with Ascendiant South America LLC, an affiliate of Ascendiant Capital Group Inc., of Irvine, Calif., which will schedule clinical trials and begin manufacturing and distribution of Sanguine’s PHER-O2 product in major countries in South America. PHER-O2 is an oxygen-carrying synthetic substitute for human red blood cells. In February, Sanguine announced a license agreement with Ascendiant Asia LLC, for clinical trials, manufacturing and distribution of PHER-O2 synthetic red blood cells throughout Asia.
Senomyx Inc., of La Jolla, Calif., demonstrated the function of a human receptor that responds to sweeteners and a related human receptor that responds to glutamate, a savory tasting molecule found in a variety of meats, cheeses and vegetables and associated with umami taste. Using cells engineered to express combinations of the human T1R genes, Senomyx showed that human T1R2 and T1R3 combine to form a receptor that responds to a variety of both natural and synthetic sweeteners and that human T1R1 and T1R3 combine to form a receptor that responds to monosodium glutamate and other umami taste substances. The results are published in the April 2, 2002, issue of the Proceedings of the National Academy of Sciences and will be presented at the annual meeting of the Association for Chemoreception Sciences that begins April 24.
SignalGene Inc., of Montreal, said a target discovery program involving its scientists and external collaborators was approved for funding by Genome Canada and Genome Quebec. A total of C$8.1 million (US$5.1 million) was funded 50 percent provided by Genome Canada, 25 percent by Genome Quebec. The program is focused on three disorders related to steroid hormones, namely osteoporosis, breast cancer and ovarian cancer.
SuperGen Inc., of Dublin, Calif., reported that long-term follow-up and independent review of results from a previously announced Phase II study of its oral anticancer compound Orathecin (rubitecan) confirmed the drug’s activity in patients with refractory pancreatic cancer who have failed prior treatments. The U.S. multicenter study enrolled 58 patients who had failed prior chemotherapy. Among 45 patients with measurable disease, 10 had objective partial tumor responses; three responded with a greater than 50 percent reduction in tumor size; and seven saw their disease stabilized, responding with less than 50 percent reduction in tumors or with no evidence of tumor growth. Median survival for the 10 responders was more than 10 months, compared to three months in the overall target population. Five of the 10 lived for more than a year, two for more than two years and one for more than three years and is still alive.
Viragen Inc., of Plantation, Fla., and Viragen International Inc., reported two agreements valued in excess of $22 million extended over a five-year period with international drug distributors to distribute Viragen’s natural alpha interferon, Multiferon. AGC, of Pakistan, has entered into an agreement to distribute Multiferon exclusively in the Middle East. This agreement supercedes the original agreement signed between Viragen and AGC in November 1998. Metdem Healthcare Ltd., of Ankara, Turkey, will be the exclusive distributor in Turkey.
Xenon Genetics Inc., of Vancouver, British Columbia, said its subsidiary, Xenon Genetics Research Inc., was awarded C$11 million (US$6.9 million) from Genome Canada and Genome Quebec in support of two projects in genomics-based drug discovery. Xenon Genetics Inc. will contribute another C$3.4 million. Both projects are to identify genes and drug targets associated with human genes.
XenoPort Inc., Santa Clara, Calif., elected Paul Goddard as chairman of the company’s board. Previously, he was the president and CEO of Elan Pharmaceuticals, a division of Elan Corp. plc, of Dublin, Ireland. The company also appointed D. Bryon Miller as vice president and chief patent counsel. He previously was the assistant secretary and director of intellectual property of Alza Corp., a wholly owned subsidiary of Johnson & Johnson, of New Brunswick, N.J. Privately held XenoPort is focused on improving the oral absorption, distribution and pharmacokinetics of drugs.