Abgenix Inc., of Fremont, Calif., began a Phase II trial of ABX-EGF in patients with colorectal cancer, the fifth Phase II study of ABX-EGF and the second for the colorectal cancer indication. The multicenter, open-label Phase II study will enroll up to 84 patients and is designed to assess the safety and efficacy of ABX-EGF in combination with standard chemotherapy, as a first-line treatment in patients with metastatic colorectal cancer. Abgenix is developing ABX-EGF in collaboration with Immunex Corp., of Seattle.
Alkermes Inc., of Cambridge, Mass., and Eli Lilly and Co., of Indianapolis, will move forward with multiple-dose Phase I studies for inhaled human growth hormone following the completion of a single-dose Phase I trial. The study was based on Alkermes’ AIR pulmonary drug delivery system and was conducted with Lilly. Conducted in healthy volunteers, the study’s findings demonstrated encouraging pulmonary bioavailability and that the formulation was well tolerated.
Altachem Pharma Ltd., of Edmonton, Alberta, signed an exclusive licensing and product development agreement for technology related to hypocrellins and their derivatives. The agreement is between Altachem’s subsidiary, SonoLight Pharmaceuticals Corp., and The Institutes of Chemistry and Biophysics, Academia Sinica of Beijing in the People’s Republic of China. Financial details were not disclosed. SonoLight focuses on the application of next-generation technologies to manage neoplastic diseases with currently unmet treatment needs such as breast cancer, prostate cancer and gastrointestinal cancers.
Applied Biosystems Group, of Foster City, Calif., an Applera Corp. business, launched its 4700 Proteomics Analyzer, a system it said is designed to provide researchers with higher-sample throughput and improved data quality and sensitivity for understanding proteins and their role in disease.
Aviron Inc., of Mountain View, Calif., said it submitted to the FDA a formal reply to the complete response letter the FDA sent Aviron on Aug. 31, relating to its biologics license application for FluMist, an intranasal influenza vaccine. The response provided additional information and clarification regarding clinical and manufacturing data, as requested by the FDA.
Biotica Technology Ltd., of Cambridge, UK, said it was awarded a Marie Curie Industry Host Fellowship grant, worth more than EUR330,000 (US$294,213), from the European Union. The grant will help fund research for the design of polyketides for use as therapeutic substances and the development of new technologies for their production within microorganisms. Biotica is focused on discovering pharmaceuticals through the targeted alteration of biosynthetic pathways, producing natural products.
Cambridge Antibody Technology plc, of Melbourn, UK, and Immunex Corp., of Seattle, said Immunex exercised an exclusive license option one of eight granted by CAT to Immunex under an agreement signed in December 2000 in respect to the development and commercialization of human monoclonal antibodies. The option gives Immunex the right to develop human monoclonal antibodies specifically for an undisclosed disease target. CAT received a license fee and will potentially receive milestone and royalty payments. (See BioWorld Today, Dec. 4, 2000.)
CollaGenex Pharmaceuticals Inc., of Newton, Pa., disclosed its plans to expand into the dermatology market, naming Jeffrey Day vice president, dermatology. The company said it would best serve its shareholders by developing indications for Periostat itself. The company said it was “excited” about encouraging clinical trial results to date of Periostat in treating inflammatory acne.
Demegen Inc., of Pittsburgh, said an article published in the December 2001 issue of Antimicrobial Agents and Chemotherapy indicated that P113D, a Demegen compound, might be an effective inhalant therapy for cystic fibrosis patients. The results suggest that P113D not only has killing activity against Pseudomonas aeruginosa, but also retains this activity in sputum. P113 is a fragment of histatin 5, one of the family of small, cationic, histidine-rich peptides found in human saliva.
DGI BioTechnologies Inc., of Edison, N.J., signed a two-year licensing and research agreement with Novo Nordisk A/S, of Bagsvaerd, Denmark, for the research and discovery of insulin-like growth factor-related antagonists for the treatment of cancer. Novo obtains exclusive rights to IGF antagonists, while DGI maintains rights to IGF agonists discovered through the collaboration. Financial terms of the agreement were not disclosed. IGF is a natural growth-promoting entity.
Digene Corp., of Gaithersburg, Md., launched its Hybrid Capture ExpressArray Kit, a research assay for gene expression analysis on microarrays, expanding the Hybrid Capture technology into the global DNA microarray life science research market. It also further positions the company in molecular diagnostics for women’s health, where Digene operates in the area of testing for human papillomavirus.
Eos Biotechnology Inc., of South San Francisco, said it transferred its therapeutic antibody target to Pharmacopeia Inc., of Princeton, N.J., and Pharmacopeia initiated high-throughput screening to identify small-molecule drug candidates. The companies will jointly own any arising compounds. Eos’ antibody target is a member of the integrin family of proteins, known to be involved in angiogenesis. The companies proposed a $197 million merger in August. Separately Tuesday, OrbiMed Advisors LLC, of New York, a beneficial owner of about 10 percent of Pharmacopeia’s outstanding stock, sent a letter to Pharmacopeia shareholders urging them to vote against the proposed merger. (See BioWorld Today, Aug. 23, 2001.)
Gene Logic Inc., of Gaithersburg, Md., and Compugen Ltd., of Tel Aviv, Israel, formed a joint collaboration to integrate Compugen’s human Gencarta annotated genomic and proteomic database with the gene expression information in Gene Logic’s GeneExpress Suite. The collaboration will provide GeneExpress researchers with a genomic and proteomic infrastructure for target selection and validation. Financial terms of the collaboration were not disclosed. Compugen’s Gencarta, introduced in March 2001, is a database of genes and transcripts derived from Compugen’s algorithms.
Genomics Collaborative Inc., of Cambridge, Mass., signed an agreement with Wyeth-Ayerst Research, a unit of American Home Products Corp., of Madison, N.J., enabling Wyeth to use the GCI Access program for genomics-based target discovery and validation. GCI Access gives Wyeth researchers defined access to the Global Repository, GCI’s proprietary database of clinical data and DNA, and tissue and serum samples collected from more than 100,000 patients.
Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., said it expects revenues to increase more than 20 percent annually and reach an estimated $2.5 billion by 2006. Revenue for the fourth quarter of 2001 grew 30 percent to $264 million, compared to revenues of $203 million for the fourth quarter of 2000. For the year, revenues increased 29 percent to $981 million, compared to revenues of $760 million for 2000.
Human Genome Sciences Inc., of Rockville, Md., and Cambridge Antibody Technology plc, of Melbourn, UK, said HGS exercised an option for an exclusive development partnership on a human monoclonal antibody being evaluated against cancer by HGS to the TRAIL Receptor 1. The companies announced the potential $67 million collaboration and product development alliance in March 2000. HGS is to develop and sell the TRAIL-R1 antibody and CAT is entitled to receive license fees, clinical development milestones and royalties on product sales. The TRAIL-R1 antibody is the second antibody drug candidate resulting from the collaboration that HGS has taken an exclusive option to, the first being LymphoStat-B, now approved for Phase I trials in autoimmune diseases. (See BioWorld Today, March 2, 2000.)
Illumitek Inc., of Herndon, Va., said Viaken Systems, of Gaithersburg, Md., chose Illumitek’s D3 platform to extend Viaken’s suite of capabilities for addressing integration challenges in the drug discovery process. Illumitek’s D3 technology integrates data mining, analysis, visualization and web-based interactivity into one platform, the company said. Financial terms were not disclosed.
Insmed Inc., of Richmond, Va., reported positive results from a Phase II dose-ranging trial of SomatoKine in patients with Type II diabetes. Improvements in insulin sensitivity and fasting blood glucose occurred with the administration of SomatoKine, with the most pronounced changes achieved with a dose of 2mg/kg. At this dose a significant decrease in average daily insulin requirement from 70.8 units at baseline to 56.5 units (-20.2 percent) at the end of the treatment period was observed. The corresponding insulin dosage change in the placebo group (n=4) was from 89 units at baseline to 87.3 units (-1.9 percent) at the end of the treatment period.
Interferon Sciences Inc., of New Brunswick, N.J., began a clinical study to test the potential of Alferon N Injection, its natural-source, multispecies alpha interferon, to prevent metastatic recurrences of cancer after surgical removal of tumors. Interferon is seeking additional indications for Alferon N Injection, currently approved for the treatment of certain types of genital warts. The study is based on research in mice with implanted melanoma, which found that a short duration of treatment with natural mouse leukocyte interferon prior to surgery significantly increased the survival rate compared to untreated controls (56 percent vs. 0 percent).
InterMune Inc., of Brisbane, Calif., began enrolling patients in a Phase II trial of Actimmune (interferon gamma-1b) injection for the treatment of severe liver fibrosis, or cirrhosis, caused by hepatitis C virus. The multicenter, placebo-controlled, 450-patient AEGIS trial (Anti-fibrotic Efficacy Gamma Interferon Study) will evaluate the safety and anti-fibrotic activity of Actimmune in HCV patients who have failed standard antiviral therapy. Patients will be randomized to receive placebo, 100 mcg or 200 mcg of the drug three times per week via subcutaneous injection for 48 weeks.
Introgen Therapeutics Inc., of Austin, Texas, reported publication of a new study in the journal Cancer describing the use of INGN 201, Introgen’s adenoviral-p53 product candidate, to treat the precancerous cells that cause certain head and neck cancers. Using in vitro models that approximate premalignant and early malignant disease, treatment with INGN 201 decreased the growth of these cells and triggered them to die via apoptosis in a dose-response fashion. Untreated, these cells display altered growth characteristics of cancer, and have lost cell growth regulatory mechanisms that can be restored by the transfer of the p53 gene through treatment with INGN 201.
Invitrogen Corp., of San Diego, launched its Research Tools Development Grants Program, a grant funding program to encourage the discovery and development of new research tools for life sciences. The program will provide awards ranging from approximately $25,000 to $100,000 per year. Grants will be announced quarterly and will focus on a different area of research each quarter.
MorphoSys AG, of Munich, Germany, expanded its existing collaboration with Biogen Inc., of Cambridge, Mass., granting Biogen access to MorphoSys’ new HuCAL Gold library for use in Biogen’s functional genomics programs. Also, the agreement increases the number of expressed sequence tags involved in the collaboration announced in December 2000. The agreement includes an option for Biogen to develop selected antibodies as therapeutics. MorphoSys will receive additional funded research and licensing payments. Further financial details were not disclosed.
Ontogen Corp., of Carlsbad, Calif., was awarded a $1.3 million Phase II Small Business Innovation Research grant from the National Institutes of Health for the development of enzyme inhibitors to aid in the regulation of blood glucose levels in people with Type II diabetes. Under the grant titled “FBPase Inhibitors for Glycemic Control in Diabetes,” Ontogen will optimize novel inhibitors of FBPase, a key enzyme involved in glucose production. Research will begin immediately and include in vitro and animal model evaluations.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., formed Avid Bioservices Inc. as a wholly owned subsidiary. Avid will provide contract services for biopharmaceutical and biotechnology businesses, including manufacturing, cell culture, process development, and testing of biologics. Avid will operate in facilities adjacent to Peregrine’s Tustin facility and will focus on two biopharmaceutical segments: monoclonal antibodies and recombinant proteins. Peregrine focuses on the development, commercialization and licensing of technologies for the treatment of cancer.
Phylos Inc., of Lexington, Mass., entered an agreement with Aventis Research & Technologies, of Frankfurt, Germany, giving Phylos a division of AR&T and creating a wholly owned subsidiary, Phylos GmbH, located in Frankfurt. Financial terms were not disclosed. Through a 1998 collaboration agreement between Phylos and AR&T, Phylos and the acquired division were developing an mRNA display technology called PROfusion. With the acquisition, Phylos re-acquired all rights to the PROfusion technology and recovered the right to grant sublicenses to third parties, the company said.
Prescient NeuroPharma Inc., of Toronto, finalized an agreement to license its anticancer compound, Anhydrovinblastine (AVLB), to Access Oncology Inc., of New York. Access now has exclusive rights to develop and market AVLB worldwide, except in Latin America and the Far East. Access will make up-front and early milestone payments of $1.25 million and development milestone payments up to $17.5 million. Access also will pay royalties on net sales and fund all further development of AVLB, including the completion of Phase II and Phase III trials. Access has an option to purchase up to $5 million of the last milestone in Prescient equity at a 50 percent premium to market at that time. (See BioWorld Today, Nov. 29, 2001.)
Protein Sciences Corp., of Meriden, Conn., and Nosan Corp., of Yokohama, Japan, said Nosan made a $1 million equity investment in PSC. The companies began a relationship in 1999 when Nosan became the exclusive distributor of PSC’s research antigens and insect cells in Japan. Nosan then exercised its option to become the exclusive distributor of PSC’s proprietary GeneXpress business in Japan.
Replicon Technologies Inc., of Danville, Calif., received a first tranche of Series A financing from Tullis-Dickerson & Co. Inc., of Greenwich, Conn. Replicon is focused on developing therapeutic applications of replicons for human tumors. Replicons are modified viruses that seek out and destroy cancer cells. The company is currently raising $5 million for future operations. Tullis-Dickerson is the founding investor of Replicon and the first investor in this round.
Scios Inc., of Sunnyvale, Calif., reported that net sales for its lead product, Natrecor (nesiritide), were $9.6 million in the fourth quarter of 2001, its first full quarter of sales. Net sales of Natrecor for the year ended 2001 were $14.1 million. Natrecor is the first of a new drug class and a recombinant form of B-type natriuretic peptide, a naturally occurring hormone secreted by the heart in response to heart failure.
Techne Corp., of Minneapolis, said the United States District Court in St. Paul, Minn., granted Amgen Inc., of Thousand Oaks, Calif., summary judgment in the amount of about $28 million, in the matter of an EPO supply dispute. The judgment is stayed for 30 days pending further order of the court. If final judgment is entered against Techne, it said it would appeal to the United States Eighth Circuit Court of Appeals. Techne acquired Amgen’s biological reagents business in 1991; the dispute arose in the summer of 2000.
Telik Inc., of South San Francisco, completed a Phase I study of its TLK286 clinical development program. Based on the results, the company plans to begin a Phase II trial of TLK286 administered weekly as monotherapy in breast cancer patients who have failed to respond or are refractory to other treatments. Also, Telik completed enrollment in the Phase II trial of TLK286 in refractory colorectal cancer, and remains on schedule with enrollment in Phase II trials for ovarian and non-small-cell lung cancers. TLK286 is a small-molecule drug candidate in development for cancers that are refractory to standard treatments. Telik’s stock (NASDAQ:TELK) rose 10.8 percent Tuesday, or $1.35, to close at $13.80.
Transgene SA, of Strasbourg, France, initiated a Phase I trial with its Adeno Interferon gamma immunotherapeutic product to treat cutaneous lymphoma. The trial will involve at least nine patients with either advanced cutaneous T-cell lymphoma or multilesional B-cell lymphoma. Transgene’s Ad-IFNg product uses a nonreplicative adenovirus vector to generate a local secretion of IFNg, producing an antitumor effect, the company said.
Vertex Pharmaceuticals Inc., of Cambridge, Mass., advanced VX-799, a small-molecule caspase inhibitor, into development for treating sepsis. Vertex is conducting preclinical studies with VX-799 in preparation for clinical trials. Caspases comprise a family of 11 known human enzymes that play roles in apoptosis and inflammation.
X-MINE Inc., of Brisbane, Calif., introduced X-Miner On-Line for microarray data mining and biological knowledge discovery. Developed by genomics experts from Stanford University, of Palo Alto, Calif., and the Whitehead/MIT Center for Genome Research, of Cambridge, Mass., XOL enables biologists to perform DNA microarray data analysis at an advanced level, it said.