Australian Cancer Technology, of Sydney, Australia, said that Phase I studies using the company's lead vaccine immunostimulant GPI-0100 demonstrated enhanced immune response in patients with relapsed prostate cancer. The results of the study were reported in an electronic publication of Vaccine.
Bavarian Nordic A/S, of Copenhagen, Denmark, said its third-generation Modified Virus Ankara (MVA) vaccine is expected to be effective against smallpox three days after vaccination, compared to traditional replicating vaccines that show protection after 10 to 14 days. The company presented data at the BIO CEO & Investor Conference in New York.
BioInvent International AB, of Lund, Sweden, presented results of in vitro tests of its HIV candidate at the 12th Conference on Retroviruses and Opportunistic Infections in Boston, which include the drug's ability to keep resistance from developing after inhibiting the virus for 20 weeks. In the resistance tests, researchers attempted to provoke the development of resistance, by transferring the virus to new cells and allowing the virus to replicate in the presence of the inhibiting antibody, but BioInvent said no resistance developed at 20 weeks. The company said the antibody will be tested in clinical trials to determine whether it maintains those anti-resistant properties.
Corgentech Inc., of South San Francisco, intends to meet with the FDA by the end of March, before the company announces Phase III data of edifoligide (E2F Decoy) for coronary artery bypass graft (CABG) failure. Corgentech and its partner, New York-based Bristol-Myers Squibb & Co., are meeting with outside experts to discuss various regulatory pathways for the product. The trial, called PREVENT IV, involves 2,400 patients undergoing CABG surgery.
DOV Pharmaceutical Inc., of Hackensack, N.J., initiated its first Phase I trial with DOV 102,677, an inhibitor of serotonin, norepinephrine and dopamine reuptake. The trial evaluates a range of doses of the product. DOV 102,677 has the potential to treat depression, attention deficit disorder and obesity.
Genaera Corp., of Plymouth Meeting, Pa., said "Evizon" has been selected as the U.S. trade name for squalamine, the company's synthetic anti-angiogenic small molecule in a Phase II trial for treating wet age-related macular degeneration. The company also is developing squalamine for cancer, interleukin-9 antibody for asthma, and Lomucin for chronic respiratory disease.
Genzyme Corp., of Cambridge, Mass., said the first patient has been treated in a new Phase II trial of locally delivered gene transfer for patients with peripheral arterial disease. The company's therapy, which uses Ad2/HIF-1 alpha, an engineered form of the HIF-1 alpha gene, is designed to promote the growth of new blood vessels and improve circulation in patients' limbs. The trial will enroll up to 300 patients at up to 35 medical centers in the U.S. and Europe.
Geron Corp., of Menlo Park, Calif., said the board of patent appeals and interferences of the U.S. Patent and Trademark Office issued a final judgment in interference No. 105,192 between Geron and Advanced Cell Technology Corp., of Worcester, Mass. In its ruling, the board found all claims of U.S. Patent No. 6,235,970, which is licensed to ACT from the University of Massachusetts, to be unpatentable.
Greystone Medical Group, of Memphis, Tenn., and the University of Tennessee Health Science Center were awarded $750,000 by the U.S. Defense Department to complete preclinical research of a drug to treat hemorrhagic shock. Initial research shows the compound invented by Bob Moore II, assistant professor at UTHSC, and licensed to Greystone Medical, protects the body's vital organs during hemorrhage by reversing critically low blood pressure.
Indevus Pharmaceuticals Inc., of Lexington, Mass., said findings presented at the 12th Conference on Retroviruses and Opportunistic Infections in Boston demonstrated that its PRO 2000, a topical microbicide, retains activity against HIV and the herpes simplex virus following intravaginal administration to HIV-infected women. Researchers from New York's Mount Sinai School of Medicine studied 20 HIV-infected women to assess the antiviral activity of the drug in cervicovaginal lavage (CVL) fluid collected before and one hour after administration of a dose of the PRO 2000 gel or a placebo gel. Analysis showed that CVL obtained after the application of PRO 2000 gel reduced both HIV and HSV infectivity by at least 1,000-fold, compared to CVL obtained at baseline. Researchers also reported that low levels of inflammatory cytokines indicated that the gel did not induce an acute inflammatory response.
Isolagen Inc., of Houston, is nearing an agreement to establish a manufacturing facility and corporate offices in Exton, Pa. The company also executed a lease for a facility in Houston to house its ongoing work in cell biology research and early assessment for new indications. Isolagen develops and commercializes autologous cellular therapies for soft- and hard-tissue regeneration.
J. Craig Venter Institute, of Rockville, Md., said it will sequence the genomes of more than 100 of the key marine microbes stored in culture collections around the world. The institute received an $8.9 million grant from the Gordon and Betty Moore Foundation to support the expanded reference collection.
Lynx Therapeutics Inc., of Hayward, Calif., said the USDA awarded University of Delaware faculty members Blake Meyers and Pamela Green a research grant to use Lynx's Massively Parallel Signature Sequencing small RNA profiling technology, under the Cooperative State, Research, Education and Extension Service program. Titled "Functional Genomics of Agriculturally Important Organisms," it focuses on small RNAs in rice.
Medarex Inc., of Princeton, N.J., expects to receive an undisclosed payment from its licensing partner, Thousand Oaks, Calif.-based Amgen Inc., for the advancement of an antibody into clinical trials. The product was developed using Medarex's UltiMAb technology and is the third such antibody in clinical development by Amgen. Medarex could receive future milestone payments and royalties.
Neoprobe Corp., of Dublin, Ohio, said the FDA accepted its request to establish a corporate investigational new drug application for Lymphoseek. The IND will transfer responsibility for the development of the product from the University of California at San Diego to Neoprobe. Lymphoseek is intended to be used in biopsy procedures for the detection of lymph nodes in a variety of tumor types, including breast, melanoma, prostate, gastric and colon cancers.
Neose Technologies Inc., of Horsham, Pa., closed the sale of about 8.1 million shares of its common stock, including about 1.1 million shares in overallotments, to raise $32.2 million. The company said it intends to use proceeds to fund preclinical and clinical development of its two lead protein products, including an improved version of red-blood-cell-stimulator erythropoietin, and an improved version of granulocyte-colony stimulating factor. Funds also will go toward capital expenditures and general working capital. (See BioWorld Today, Feb. 22, 2005.)
Neurochem Inc., of Montreal, filed a short form preliminary prospectus with the Canadian securities regulators and a registration statement with the SEC for a proposed offering of 4 million common shares. Neurochem said it plans to use the proceeds to fund clinical trials of its investigational products, including Alzhemed, (3-amino-1-propanesulfonic acid) in a Phase III trial for Alzheimer's disease, as well as to complete preclinical and research programs.
Sangart Inc., of San Diego, completed enrollment in its Phase II trial involving Hemospan, (MP4), a hemoglobin-based oxygen carrier designed to serve as an alternative for blood transfusions. The company said it expects to start receiving results from the 90-patient trial over the next few months.
Stressgen Biotechnologies, of San Diego, said it filed a Canadian amended and restated preliminary prospectus pursuant to which it intends to raise up to $50 million. Stressgen has entered an agreement with two broker-dealers, under which the agents have agreed on a best-efforts basis to place common shares of the corporation. The offering price per share and the number of shares to be placed will be determined prior to the filing of the final prospectus. Stressgen plans to use the proceeds of the offering to fund development and commercialization of HspE7.
Vertex Pharmaceuticals Inc., of Cambridge, Mass., said the U.S. District Court for the District of Massachusetts has granted its motion to dismiss a purported class-action lawsuit against the company's officers and a former employee. The plaintiffs claimed that the defendants were misleading regarding facts about an investigational drug candidate. Vertex is focused on drugs to treat viral disease, inflammation, autoimmune disease and cancer.
Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., was granted priority review status by the FDA for its new drug application for dalbavancin, a once-weekly antibiotic to treat complicated skin and soft-tissue infections. The company expects to commercialize the product, if approved, by the first quarter of 2006. The NDA was submitted in December and includes results from three Phase III trials.
Visient Therapeutics Inc., of Seattle, a wholly owned subsidiary of Light Sciences Corp., enrolled the first patient in a Phase I trial evaluating Litx (Light Infusion Technology) in advanced age-related macular degeneration. Litx is a combination product comprising a photo-reactive agent, LS11, activated by non-coherent light infusion devices.
The WiCell Research Institute, an affiliate of the University of Wisconsin in Madison, said researchers have developed a way of growing human embryonic stem cells in the absence of mouse-derived feeder cells that are believed to be a source of potential contamination. Working with three of WiCell's five human embryonic stem cell lines, researchers explored molecular interactions within the stem cell growth medium, and discovered that, in certain conditions, fibroblast growth factor 2 accomplishes the same role that feeder cells are thought to play by ensuring that the stem cells remain in their undifferentiated state, capable of proliferation. The findings were published in the Feb. 17, 2005, issue of Nature Methods.
Zonagen Inc., of The Woodlands, Texas, said that a poster reporting results after three months of dosing from its study of Progenta in the treatment of uterine fibroids was presented at the Advances in Uterine Leiomyoma Research: NIH 2nd International Congress. After three months of exposure, the mean change in fibroid cross sectional area, reported as a percent of time zero area, was 95 percent for placebo, 83.8 percent for 12.5-mg Progenta, 64.9 percent for 25-mg Progenta, 59.1 percent for 50-mg Progenta and 62.5 percent for Lucrin.