Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, was notified by Boston Scientific Corp., of Boston, that BSC announced preliminary, six-month results of its TAXUS III paclitaxel-eluting stent clinical trial. TAXUS III is a single-arm registry examining the feasibility of implanting up to two paclitaxel-eluting stents for the treatment of in-stent restenosis. Enrollment of 30 patients was completed in July. The study reported a 7 percent 30-day MACE rate (one myocardial infarction and one target vessel revascularization unrelated to the stent study), both of which occurred during the stent placement procedure. No early stent thromboses were reported, and systemic paclitaxel levels were undetectable at 30 days, consistent with the data from TAXUS I. Six-month data demonstrated a 17 percent MACE rate.
Antares Pharma Inc., of Exton, Pa., and MacroMed Inc., of Salt Lake City, entered into a technology and business development collaboration. The companies will work to optimize MacroMed’s ReGel sustained-release gel technology for use with Antares’ needle-free and mini-needle injection technologies. The goal will be to develop a depot drug delivery system that releases medication from a subcutaneous injection site reservoir over a two-, four- or six-week period.
ArQule Inc., of Woburn, Mass., signed a one-year technology access agreement with Pharmacia Corp., of Peapack, N.J., granting Pharmacia nonexclusive access to its proprietary ADMET simulation technology. Pharmacia will have access to ArQule’s computational models for the purposes of generating absorption, distribution, metabolism, excretion and toxicity predictions. The agreement includes an option for renewal. Financial details were not disclosed.
Avid Bioservices Inc., of Tustin, Calif., a subsidiary of Peregrine Pharmaceuticals Inc., said it finalized a manufacturing supply agreement with Inhibitex Inc., of Atlanta, for the production of therapeutic monoclonal antibodies for use in future clinical studies.
Caliper Technologies Corp., of Mountain View, Calif., said it has two new biological assays for drug screening and a new “12-sipper” LabChip device for faster throughput. The first new assay, the calcium flux assay, extends the benefits of Caliper’s microfluidic lab-on-a-chip technology to high-throughput screening of drug compounds that promote or inhibit calcium-mediated events in live cells. Caliper expects shipments of its first 12-sipper LabChip device to begin later this year, and it also has in late-stage development an ion channel assay.
Defence Research Establishment Suffield, of Medicine Hat, Alberta, Biopolymer Engineering Inc., of Eagan, Minn., and Biophage Pharma Inc., of Montreal, said research demonstrated that a complex carbohydrate derived from Baker’s yeast significantly increased the survival rate of mice infected with a lethal dose of anthrax spores. The carbohydrate, called beta 1, 3 glucan, is well known as an immune enhancer that helps the body increase its ability to fight infection. With anthrax, the effect was achieved by enhancing the immune system’s ability to kill anthrax spores before they germinated inside the lungs and produced toxins.
Generex Biotechnology Corp., of Toronto, said Health Canada approved an investigational new drug application to begin trials of buccal morphine for pain treatment. The approval follows the completion earlier this year of a successful proof-of-concept study of morphine delivered systemically through the buccal cavity via the company’s technology. Generex is pursuing these developments through its business venture with Elan Corp. plc, of Dublin, Ireland.
DyoDelta Biosciences Ltd., of London, entered a collaboration for the exclusive license of a pharmaceutical compound program developed by John Matsoukas, head of medicinal chemistry at the University of Patras in Greece. The lead compound, DDB-202 for the therapeutic management of multiple sclerosis, involves the design and use of peptide analogues of disease-associated myelin epitopes to induce peripheral T-cell tolerance. MBP (myelin basic protein) is one of the candidate autoantigens in MS, and DDB-202 is designed as an analogue of MBP’s most immunodominant region in human MS.
DNAPrint Genomics Inc., of Miami, said University of Miami doctors presented the results of an ongoing pharmacogenomics study with the company at the 33rd annual Society for Gynecological Oncology meeting in Miami. DNAPrint scientists used a heuristic method with geometrical projection to identify and model eigengenotypes, or population-based vectors of genome information, that serve as features for variable paclitaxel response. The team found certain eigengenotypes were strongly predictive for first-line chemotherapy response in these patients. Data suggested that by screening patient genomes for these eigengenotypes prior to the beginning of chemotherapy, most non-responders could be flagged and redirected toward doses and/or alternative chemotherapy more appropriate for their genetic constitution.
Eli Lilly and Co., of Indianapolis, which is partnered with Centocor Inc., of Malvern, Pa., reported that results of studies show that treating patients with the anti-platelet drug ReoPro (abciximab) following a heart attack helps increase blood flow to the heart, thus reducing patients’ risk of death, recurrent heart attack and the need to re-open clogged arteries. The data, presented at the annual meeting of the American College of Cardiology in Atlanta, highlighted the strength of ReoPro in treating patients with diabetes, visible and non-visible thrombus and complex lesions.
Genteric Inc., of Alameda, Calif., relocated and expanded its corporate and research operations to a newly constructed facility in Alameda. The facility provides more than twice the space of the company’s previous facility. It contains laboratories for research and development of its gene transfer technology platforms.
Proteome Systems Ltd., of Sydney, Australia, and Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., agreed to collaborate on a proteomics research program to discover protein targets for cystic fibrosis. These proteins may be used to monitor the progression of the disease and lead to more effective intervention strategies, or as potential targets for the development of new drugs.
Gentris Corp., of Research Triangle Park, N.C., secured $1.5 million in funding from a combination of institutional and angel investors. The funding will provide expansion capital for the company to accelerate its efforts in pharmacogenomic testing products and services and hire key staff.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., extended until April 8 the expiration time for its tender offer for all of its outstanding 8.74 percent Series D senior notes due 2008. ICN’s obligation to accept for payment, and to pay for, any notes tendered remains subject to certain conditions, including the completion of the previously announced initial public offering of a minority interest in the company’s subsidiary, Ribapharm Inc. As a result of the extension, the price determination date has been extended until April 3.
MGI Pharma Inc., of Minneapolis, initiated a Phase I trial of irofulven, its anticancer compound, in combination with the antitumor agent cisplatin, in patients with advanced solid tumors. The primary objective of the dose-escalating trial is to determine the maximum tolerated dose of the two drugs when used in combination. Secondary objectives are to determine the safety, antitumor activity and the pharmacokinetic profile of irofulven and cisplatin when administered in combination.
Nabi Biopharmaceuticals, of Boca Raton, Fla., said it will redeem its 6.5 convertible subordinated notes for cash effective April 5. With this action, Nabi avoids paying interest of approximately $3.9 million. The notes have an original maturity date of Feb. 1, 2003. This redemption eliminates all of the company’s remaining debt.
Questcor Pharmaceuticals Inc., of Union City, Calif., raised $4 million in two separate transactions through the issuance of 8 percent convertible debentures due in 2005 to SF Capital Partners, of San Francisco, and Defiante Farmaceutica Unipessoal LDA, a subsidiary of Sigma-Tau Finanziaria SpA, of Rome. The debentures are convertible into shares of Questcor’s common stock at a fixed conversion price of $1.58 per share. Upon maturity and under certain circumstances, Questcor has the option to repay the principal in stock or cash and may, under certain circumstances, redeem the debentures for cash prior to maturity. Questcor also issued warrants to the investors to purchase up to an aggregate 1.5 million shares of common stock at $1.70 per share. The warrants expire on March 15, 2006.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported results from a nonclinical study supporting Zadaxin’s observed mechanism of action, indicating that it promotes an antiviral immune system response by increasing the Th1 subset of helper T cells. This study was conducted on liver-infiltrating T cells from biopsies taken from patients with chronic hepatitis B enrolled in SciClone’s Phase III trial in Japan. Zadaxin, an immune system enhancer, is a synthetic preparation of thymosin alpha 1, an immune system peptide that exists naturally in humans.
Scios Inc., of Sunnyvale, Calif., said the first annual meeting of the Acute Decompensated Heart Failure National Registration (ADHERE) heart failure registry was held in Atlanta to review national data results and to discuss current treatment for acute heart failure and goals for the registry in 2002. More than 240 principal investigators and site coordinators attended the meeting. The registry is on track to reach an enrollment of 10,000 patients from 200 U.S. hospitals this year.
Sequenom Inc., of San Diego, introduced its ultra-high-throughput genotyping platform, the MassArray 200K system. The company said this process is an integrated and fully automated industrial-scale single nucleotide polymorphism analysis platform. The system has demonstrated capacities of up to 200,000 individual analysis reactions per day, which can be increased to more than 1 million analyses per day when optimized for multiplexing.
Transkaryotic Therapies Inc., of Cambridge, Mass., reached a settlement in gene therapy patent interferences involving TKT; Genetic Therapy Inc., a subsidiary of Novartis AG; Syntex, a subsidiary of Roche Holdings Inc.; and Cell Genesys Inc. The settlements allow TKT to practice its nonviral ex vivo gene therapy under royalty-free licenses in the event that any broad claims to gene therapy survive the original interference or issue in any of the pending interferences.
Zetiq Technologies Ltd., of Rehovot, Israel, entered a research collaboration with the Karolinska Institute in Stockholm, Sweden. The goal is to identify new tumor suppressor genes, which provide protection against unrestricted cell proliferation. Zetiq will use its CamaRx technology platform to screen a large number of putative tumor suppressor genes being studied at the institute. CamaRx tests cells for a phenotype labeled Cancer Associated Metabolic Atypia, a collection of basic metabolic traits characteristic of most malignant cells.