3D Molecular Sciences Ltd., of Cambridge, UK, named Elizabeth Hill CEO. Previously, she operated her own consulting business. 3D is looking to commercialize a particle-based assay platform designed for large-scale genomic and proteomic analysis.
Advanced Viral Research Corp., of Yonkers, N.Y., said James Dicke, a member of its board, purchased $1 million of its convertible debentures in a private placement, while business advisory board member Peter Lunder purchased $500,000 worth. The principal balance is convertible into shares of common stock as follows: 20 percent on the original issue date and an additional 20 percent every six months thereafter.
ALS Association in Calabasas Hills, Calif., launched a $1.5 million research project to reduce the time taken to identify the genes that cause ALS, also called Lou Gehrig's disease. The first part of the three-phase project involves development of bacterial artificial chromosome (BAC) libraries from familial ALS patients to enable the sequencing of large regions of the chromosome linked to familial ALS. Sequencing of the BAC libraries will form the second phase of the project. The third phase involves identifying sequence changes unique to the patient population.
Altair Nanotechnologies Inc., of Reno, Nev., used its nanoparticle process to develop a new pharmaceutical/new chemical entity to treat elevated phosphate levels in kidney dialysis patients. Making use of the same process, Altair also created a new drug dosage form for an existing pharmaceutical. Patents covering the composition of matter and the manufacturing process for the new active pharmaceutical ingredient will be filed this week.
Alteon Inc., of Ramsey, N.J., began a Phase IIa trial of its lead A.G.E. crosslink breaker, ALT-711, in patients with diastolic heart failure. The study, called the Diamond [Distensibility Improvement with ALT-711 Remodeling in Diastolic Heart Failure] trial, will seek to determine if ALT-711 can have a direct remodeling impact on a stiff heart, thus offering promise as a therapy.
AngioGenex Inc., of New York, entered a one-year sponsored development agreement with the pharmaceutical division of Kirin Brewery Co. Ltd., of Tokyo. AngioGenex will apply its anti-Id technology to create a genetically altered mouse that will be used in research on various human diseases including cancer. Kirin will compensate AngioGenex for providing the mouse, and both companies will use the mouse in research programs.
Bioxel Pharma Inc., of Quebec, closed its private placement of C$2.5 million (US$1.6 million) in 15 percent convertible corporate debentures. Subscribers agreed to purchase an aggregate principal amount of debentures convertible at a price of C$1.15 per share if it is converted on or before July 14, 2003, and at a conversion price of $1.27 per share if converted after July 14, 2003, and on or before July 14, 2005. Bioxel is focused on developing, manufacturing and marketing naturally derived taxanes.
Cel-Sci Corp., of Vienna, Va., said the American Stock Exchange accepted its plan to bring itself into compliance with continued listing standards. Cel-Sci fell from compliance by having shareholder equity of less than $4 million and losses in three of its four most recent fiscal years. Cel-Sci has been notified that, subject to periodic reviews and continuing progress, it has until Dec. 31, 2003, to regain compliance.
CombiMatrix, a majority owned subsidiary of Acacia Research Corp., of Newport Beach, Calif., reached a milestone in its strategic alliance with Roche Applied Science, a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The alliance includes a collaboration to develop and commercialize CombiMatrix's DNA microarray technology. Roche will market the hybridization reader instrument, flexible custom content microarrays and predesigned catalogue content microarrays in combination with its matching labeling and hybridization reagents as well as bioinformatic tools.
Devgen NV, of Ghent, Belgium, entered a research collaboration with Genentech Inc., of South San Francisco, in which Devgen will use its C. elegans in vivo-based RNAi technology and its Function Factory tool to evaluate the function of Genentech's genes in signaling pathways. Function Factory links phenotypes induced by gene knockouts or drug exposure in C. elegans to the biological pathway in which the genes or drugs operate. Financial terms were not disclosed.
Dyax Corp., of Cambridge, Mass., and Debiopharm SA, of Lausanne, Switzerland, reported results of a Phase IIa study conducted in adult patients with cystic fibrosis using DX-890, a recombinant inhibitor of human neutrophil elastase. In the first stage, seven patients were treated with 7.5 mg of DX-890. Inhibition of elastase in sputum was observed and was complete in two subjects. In the second stage, 19 patients were treated with a 30-mg dose of DX-890 per treatment. The pulmonary function tests did not show adverse changes compared to baseline. The patients had inhibition of sputum neutrophil elastase following the therapy, an effect that persisted from one inhalation treatment to the next.
Enzo Biochem Inc., of Farmingdale, N.Y., said the U.S. Court of Appeals for the Federal Circuit issued a ruling that reverses a summary judgment issued earlier by a Federal District Court invalidating an Enzo gonorrhea detection patent and reinstating Enzo's suit alleging patent infringement against Gen-Probe Inc. and four other defendants, returning the case to the trial court. The Court of Appeals on April 2 affirmed the grant of summary judgment involving Enzo's U.S. Patent No. 4,900,659, which is directed to nucleic acid probes for the detection of the bacteria that cause gonorrhea.
Exhale Therapeutics Inc., of Belmont, Calif., received notice that ETX-100, its lead compound, was granted orphan drug status by the FDA. The company applied for the designation in December for the treatment of patients with alpha-1 antitrypsin deficiency. AAT deficiency is a common inherited pulmonary disorder that can result in emphysema in adults.
Geron Corp., of Menlo Park, Calif., granted a nonexclusive license to Variagenics Inc., of Cambridge, Mass., relating to Geron's human telomerase reverse transcriptase (hTERT) technology for pharmacogenomic applications. Variagenics will use hTERT to create immortalized cell lines from a cell type suited for identifying DNA polymorphisms and haplotypes. The immortalized cell lines will enable Variagenics to produce an unlimited quantity of nucleic acids for DNA sequencing, the company said. Financial and other terms were not disclosed.
GTC Biotherapeutics Inc., of Framingham, Mass., completed data gathering and analysis in the pharmacokinetic study of recombinant human antithrombin III (rhATIII) in patients with a hereditary deficiency of the antithrombin blood protein and submitted data for peer review and presentation at the September British Society for Haemostatis and Thrombosis meeting. The study, which monitored 15 healthy adult hereditary-deficient patients over a six-day period, assessed whether there were any immunologic responses and how long rhATIII remained in the blood.
Human Genome Sciences Inc., of Rockville, Md., received from GlaxoSmithKline plc, of London, an undisclosed milestone payment after beginning Phase I trials of SB-462795 to evaluate its potential in treating osteoporosis patients. Human Genome Sciences would receive additional milestone payments under terms of the 1993 agreement if SB-462795 moves through development, and will receive royalties on product sales. In addition, Human Genome Sciences has an option to co-promote an approved drug in North America and Europe.
Isolagen Inc., of Houston, completed a $10.1 million private offering of about 2.9 million shares of 8 percent Series A convertible preferred stock at $3.50 per share. Each share of preferred stock is convertible into two shares of common stock at any time after issuance. Isolagen focuses on the development and commercialization of autologous cellular systems for hard- and soft-tissue generation and other therapies.
Kosan Biosciences Inc., of Hayward, Calif., was awarded by the National Cancer Institute in Bethesda, Md., a $100,000 Phase I Small Business Innovative Research grant to develop economical methods to produce Maytansine analogues for targeted anticancer therapeutics. Kosan said it plans to use its gene-engineering technology to produce Maytansine analogues and enhance them with features to allow better control of their delivery.
MBT Munich Biotechnology AG, of Martinsried, Germany, started an open-label Phase Ib/II trial of its tumor diagnostic agent, LipoRed. The study is designed to support the investigation of LipoRed during surgery among patients with head and neck cancer. LipoRed is expected to allow a more reliable identification of the tumor and better differentiation from surrounding tissue, the company said.
ProdiGene Inc., of College Station, Texas, began commercial scale-up of aprotinin, a protease inhibitor used in cardiac surgery, wound healing and as a component in pharmaceutical manufacturing. Aprotinin produced in maize provides an alternative to animal-derived material. ProdiGene also will market aprotinin for use in cell culture, research and other nonclinically regulated markets.
SangStat Medical Corp., of Fremont, Calif., completed enrollment in a Phase II/III study of ABX-CBL, a monoclonal antibody being developed with Abgenix Inc., also of Fremont. The 92-patient study examines the use of ABX-CBL as a treatment for steroid-resistant graft-vs.-host disease in allogeneic bone marrow transplant patients. The prospective, randomized, blinded, international, multicenter trial compares ABX-CBL to Atgam (Anti-thymocyte Globulin), with endpoints including safety, response and survival at 180 days.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported results of a study demonstrating that Zadaxin (thymalfasin, thymosin alpha 1) helps clear the hepatitis B virus in patients in the immune-tolerant phase of the infection. After 26 weeks of therapy and 52 weeks of follow-up observation, 15.6 percent of 32 hepatitis B immune-tolerant patients demonstrated a complete response to Zadaxin therapy in combination with the nucleoside analogue famciclovir, as measured by a sustained seroconversion of hepatitis B e-antigen and the disappearance of hepatitis B viral DNA. The study was published in the July issue of The Journal of Viral Hepatitis.
Serono SA, of Geneva, and Genset SA, of Paris, said that Serono France Holding SA, a wholly owned subsidiary of Serono, began the previously announced cash offer for all outstanding American depository shares of Genset and all ordinary shares, convertible bonds and warrants of Genset held by U.S. holders. Serono France Holding is offering the U.S. dollar equivalent of €3.25 in cash for each Genset ADS, €9.75 in cash for each Genset share, €102.64 in cash for each Genset OCEANE, €1 for each 1998, 1999, 2000 or 2001 warrant and €6.50 for each 2003 warrant. Serono France Holding also began an offer to purchase all of Genset's shares, OCEANEs and warrants held by non-U.S. persons in a separate, but concurrent and related, offer in France. Also, Genset closed its research facility in San Diego.
Structural Bioinformatics Inc., of San Diego, was awarded a Phase II Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., for the continued development of an anthrax lethal factor inhibitor. The $754,259 two-year grant is expected to allow the company to develop a small-molecule nonpeptide inhibitor of anthrax lethal factor.
Viragen Inc., of Plantation, Fla.; AviGenics Inc., of Athens, Ga.; the Roslin Institute in Edinburgh, Scotland; and Helen Sang said they resolved all lawsuits amongst themselves. Sang is an avian transgenics scientist. The companies were contending avian transgenic technology. AviGenics said Sang fulfilled her obligations to AviGenics, allowing her to pursue Viragen's avian transgenics project.