Allvivo Inc., of Lake Forest, Calif., received a Small Business Innovation Research grant from the National Science Foundation to develop its biomimetic surface technology. The technology binds selected proteins to plastic surfaces but preserves the proteins' function while preventing other proteins or cells from adhering to the surface. The technology can be used to examine cell behavior, develop medical devices and in tissue engineering and cell therapy applications.
Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, began a Phase II study of Paxceed (micellar paclitaxel for injection) to treat patients with rheumatoid arthritis. The open-label, multicenter study plans to enroll 50 RA patients between the ages of 21 and 70 who have failed treatment with at least one disease-modifying anti-rheumatic drug. The study is designed to determine efficacy with respect to RA signs and symptoms, and radiographic progression.
Aphton Corp., of Miami, said the FDA reviewed Aphton's request for fast-track designation for its G17DT (anti-gastrin) immunogen under its investigational new drug application to treat pancreatic cancer patients together with the chemotherapy gemcitabine. The FDA concluded that G17DT meets the criteria for fast-track designation.
ARC Pharmaceuticals Inc., of Vancouver, British Columbia, was awarded a C$225,295 (US$141,948) nonrefundable contribution from the National Research Council's Industrial Research Assistance Program. These funds will be used for the development of ARC's surgical adhesion disease research program. Products currently used to prevent surgical adhesion disease include films, gels and sprays at the time of surgery to act as physical barriers to inhibit the formation of adhesions between organs. ARC scientists have incorporated anti-inflammatory compounds into polymeric gels that are designed to prevent surgical adhesion disease.
Axonyx Inc., of New York and Melbourne, Australia, entered into a three-year consulting and research agreement with David Small, head of the laboratory of molecular neurobiology at the University of Melbourne, covering a process targeted at identifying early biochemical events associated with beta-amyloid toxicity. The process has confirmed the central role of beta-amyloid binding as a key pathological event in nerve cell membrane damage.
Biotica Technology Ltd., of Cambridge, UK, expanded its macrolide anti-infectives collaborative research agreement with Pfizer Inc., of New York. Biotica will manipulate microbial polyketide biosynthetic pathways to produce macrolide templates for further chemical derivatisation by Pfizer. The expanded collaboration adds new structure-based targets to the existing program, which will continue. Pfizer will undertake development and marketing of any resulting candidates. Specific financial terms were not disclosed.
BioVex Ltd., of Oxford, UK, signed a worldwide patent license agreement with the U.S. Public Health Service. The agreement allows exclusive use of human melanoma antigens MART-1 and gp100 in therapeutic cancer vaccines based on herpesvirus vectors. Characterized at the National Cancer Institute, a unit of the National Institutes of Health in Bethesda, Md., the melanoma antigens will be used by BioVex in its therapeutic vaccine, ImmunoVEX tri-melan. Financial terms were not disclosed.
Cangene Corp., of Toronto, said it was awarded a contract by the Centers for Disease Control and Prevention in Atlanta to develop a clinical-grade hyperimmune globulin to be used as an adjunct to antibiotic therapy in critically ill patients with anthrax infection. The globulin would be used for preclinical studies and human compassionate use and safety testing, the company said. Financial terms were not disclosed.
Codexis Inc., of Redwood City, Calif., a subsidiary of Maxygen Inc., said DSM NV, of Heerlen, the Netherlands, commercialized a process for the manufacture of a pharmaceutical intermediate using Codexis' MolecularBreeding directed molecular evolution technologies. As a result, Codexis will receive royalty payments from DSM under a March 1999 agreement with Maxygen, which Codexis later extended in June 2002.
Cytos Biotechnologie AG, of Schlieren, Switzerland, entered a merger agreement with Asklia Holding AG, of Bern, Switzerland. Cytos, which develops Immunodrugs designed to trigger a body's immune system, said it aims to start trading on the SWX Swiss Exchange Oct. 29. Asklia shareholders will receive five Cytos shares with a value of CHF0.10, in exchange for one Asklia share. Cytos reported cash and equivalents of CHF54.2 million (US$36.3 million), which it said assures development through the end of 2004. Asklia, which has ceased all operating activities, already sold businesses focused on child nutrition and veterinary and dental medicine. It discontinued its dermatology business.
Discovery Genomics Inc., of Minneapolis, and AngioGenetics AB, of Gothenburg, Sweden, agreed to undertake a joint study under which genes identified by AngioGenetics will be validated in vivo by Discovery Genomics. The focus will be on angiogenesis regulation. Any revenues generated through the collaboration will be shared. Further financial terms were not disclosed.
Endovasc Ltd. Inc., of Montgomery, Texas, established an orphan drug trust to develop drugs for rare diseases. Endovasc has two cardiovascular drugs, Angiogenix and Liprostin, approved for final FDA Phase III trials. The company plans to select at least one orphan drug indication for each drug and fund the development with proceeds from the trust, which the company said will offer tax credits to investors.
Enzon Inc., of Piscataway, N.J., said Schering-Plough Corp., of Madison, N.J., launched in Europe the PEG-Intron prefilled pen (peginterferon alfa-2b) single-dose delivery system for the treatment of hepatitis C. PEG-Intron is a longer-acting form of Intron A injection that uses PEG technology developed by Enzon. Under a licensing agreement, Enzon is entitled to royalties on worldwide sales of PEG-Intron, on which Schering-Plough holds a worldwide license.
GenVec Inc., of Gaithersburg, Md., completed patient accrual in the Phase I study of its lead oncology product candidate, TNFerade, in patients with soft-tissue sarcoma of the extremities. A total of 14 patients were enrolled in the study conducted at five U.S. sites. GenVec said it would present data at November's EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics conference in Frankfurt, Germany.
Geron Corp., of Menlo Park, Calif., renewed a matching grant from the University of California BioSTAR project to support continued research on the use of human embryonic stem cells to derive oligodendrocytes for the treatment of spinal cord and related central nervous system injuries. The work was initiated in August 2001, and the current plan calls for building on the project, including the reproducible derivation of oligodendrocytes from hESC lines and restoration of function in animal models of spinal cord and demyelination injuries.
Guilford Pharmaceuticals Inc., of Baltimore, said its neuroimmunophilin ligand, GPI 1485, demonstrated neuroprotective and neuroregenerative activity in preclinical models of post-prostatectomy erectile dysfunction. GPI 1485 belongs to a class of compounds called neuroimmunophilin ligands.
Icagen Inc., of Research Triangle Park, N.C., presented at the Sickle Cell Disease Association of America meeting in Washington results from its Phase Ib trial of ICA-17043, a small molecule under development for the chronic treatment of sickle-cell disease. In the randomized, double-blind, placebo-controlled safety study in 28 patients, ICA-17043 produced no evidence of dose-limiting or serious treatment-related side effects. Also, following the administration of a single dose, substantial inhibition of the Gardos channel, a potassium channel located on the membrane of red blood cells, was seen.
Immunetrics Inc., of Pittsburgh, appointed Steven Chang CEO, effective immediately. Previously, Chang was the founding CEO of Futuristics Labs Inc., also of Pittsburgh, where he led two financing rounds totaling more than $10 million over a three-year period. Immunetrics has developed in silico simulation technology designed to capture the complexity of the inflammatory disease response in humans.
Kaleidos Pharma Inc., of Seattle, formerly named Stem Cell Pharmaceuticals Inc., signed a Materials Cooperative Research and Development Agreement with the surgical neurology branch of the National Institute of Neurological Disorders and Stroke at the National Institutes of Health in Bethesda, Md. NIH researchers will obtain KPI's compound, transforming growth factor-alpha, to conduct primate studies to evaluate the potential of TGF-alpha in the treatment of Parkinson's disease.
Marshall Edwards Inc., a subsidiary of Novogen Ltd., of Sydney, Australia, said its lead anticancer compound, phenoxodiol, entered a Phase II trial in patients with leukemia, at the Royal North Shore Hospital in Sydney. Other Phase II trials are planned using phenoxodiol in patients with selected tumor types, including leukemias, ovarian, renal and prostate cancers, which are known to be associated with a defect of their death receptor mechanisms. The company said phenoxodiol has been shown specifically to target those mechanisms.
Novuspharma SpA, of Milan, Italy, signed a three-year Cooperative Research and Development Agreement with the U.S. National Cancer Institute's Developmental Therapeutics Program Screening Technologies Branch in Frederick, Md. The agreement was for the discovery and development of small-molecule inhibitors of hypoxia inducible factor 1-alpha, which the company said plays a critical role in angiogenesis. Novuspharma will provide technical expertise and reagents for the development of biochemical assays targeting HIF-1 alpha, together with test compounds, medicinal chemistry expertise for lead optimization and chemical synthesis of analogues.
Nymox Pharmaceutical Corp., of Maywood, N.J., priced a private placement of 91,000 shares at $4.40 per share, raising $400,400. The company said the funds would be used for general corporate purposes. Nymox has filed an investigational new drug application with the FDA for NX-1207, a product designed to treat benign prostatic hyperplasia in men.
Palatin Technologies Inc., of Cranbury, N.J., presented results of its Phase IIa trial of PT-141 for sexual dysfunction, at the International Society for Sexual Impotence Research meeting in Montreal. Twenty-four patients with mild to moderate male erectile dysfunction, who were responsive to currently available oral treatments, were enrolled in the trial. Results indicated that PT-141 had a positive effect on both the primary endpoint, duration base rigidity greater than 60 percent of full base rigidity vs. placebo (p<0.001), and the secondary endpoint, duration base rigidity greater than 80 percent of full base rigidity vs. placebo (p<0.01). PT-141 works through stimulation of receptors in the central nervous system rather than acting directly on the vascular system.
QLT Inc., of Vancouver, British Columbia, reported the U.S. District Court for the District of Massachusetts entered a judgment in favor of QLT on all claims brought against it by Massachusetts Eye and Ear Infirmary in a lawsuit initiated by MEEI on April 24, 2000, related to a patent covering verteporfin as the photoactive agent in treating certain eye diseases. In granting summary judgment for QLT on each of the eight counts, the court determined that there was no merit to any of MEEI's claims. MEEI's complaint had alleged breach of contract, misappropriation of trade secrets, conversion, misrepresentation, unjust enrichment and unfair trade practices, and sought damages, an injunction and other relief.
RxKinetic Inc., of Louisville, Colo., was awarded a $224,500 grant from the National Institute of Allergy and Infectious Diseases in Bethesda, Md., to fund early stage development of an adjuvant/delivery system for anthrax vaccine. The program will use the company's ProJuvant technology, in collaboration with research conducted at the Medical College of Ohio, in an effort to create an improved vaccine against Bacillus anthracis. ProJuvant is a polymer-based matrix that incorporates an immune response enhancer.
Sepracor Inc., of Marlborough, Mass., said it repurchased, in privately negotiated transactions, an aggregate of about $131.1 million face value of its 7 percent subordinated debentures due 2005, for an aggregate consideration of about $84.8 million in cash, excluding accrued interest. Sepracor said interest savings would be about $29.7 million over the remaining life of the debentures. Sepracor's drug development program includes candidates for the treatment of respiratory, urology and central nervous system disorders. Sepracor's stock (NASDAQ:SEPR) gained $1.29 Tuesday, or 30.7 percent, to close at $5.29.
Serenex Inc., of Durham, N.C., entered a collaboration with Chiron Corp., of Emeryville, Calif., to use Serenex's technology to discover new drug targets and potential off-targets. Chiron will supply Serenex with small-molecule, drug-like compounds, and Serenex will use its Proteome Mining and Function Proteome Fractionation technologies to screen the compounds against thousands of potential protein targets simultaneously. Serenex will receive up-front payments for research funding and potential milestone and royalty payments.
Sucampo Pharmaceuticals Inc., of Bethesda, Md., began a Phase II trial of RU-8811 for the treatment of patients with non-alcoholic steatohepatitis disease. The study will aim to enroll about 20 patients confirmed to have non-alcoholic fatty liver disease Type III and IV. RU-8811 is a functional fatty acid that showed activity in protecting against liver disease in animal models, Sucampo said.
SuperGen Inc., of Dublin, Calif., entered definitive purchase agreements for the private placement of common stock to several institutional investors. SuperGen will issue about 1.8 million shares at $2.50 per share, together with four-year warrants to purchase about 1.8 additional shares of stock with about 1.2 million of such warrants having an exercise price of $4 per share and 603,338 of the warrants having an exercise price of $5 per share. SuperGen's stock (NASDAQ:SUPG) fell 10 cents Tuesday to close at $2.39.
Tanox Inc., of Houston, said the FDA granted fast-track status to TNX-901 for the treatment of patients with peanut allergies. TNX-901 is a humanized anti-IgE antibody being developed to provide protection against reaction to accidental peanut ingestion. A double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy in patients with the allergy met the primary endpoint with statistical significance.