Active Biotech AB, of Lund, Sweden, began a Phase II study of the tablet form of SAIK-MS, for the treatment of multiple sclerosis. The objective of the multicenter, randomized, double-blind, three-arm, placebo-controlled trial is to demonstrate that SAIK-MS reduces the progression of MS-related brain lesions in patients suffering from relapsing MS, and to show that the progression of the disease is slowed down. The 18-month study is planned at a total of 20 hospitals in the UK, the Netherlands, Russia and Sweden.
Affitech AS, of Oslo, Norway, said it converted its option into an exclusive worldwide license for the vaccine delivery technology Troybodies, which uses specially engineered antibodies to position candidate antigenic T-cell epitopes on MHC class II molecules of antigen-presenting cells. The decision was made following studies that demonstrated the ability of the technology to elicit a specific cellular immune response in vivo. Affitech secured an exclusive option to Troybodies from the technology’s inventors at the University of Oslo and the Norwegian National Hospital. The option will now be converted to an exclusive worldwide license with unrestricted sublicense rights. As part of the option agreement, Affitech will enter into a research and development plan with the university on cancer and autoimmunity.
Avanir Pharmaceuticals Inc., of San Diego, said that enrollment has been completed in a Phase II/III trial of Neurodex in the treatment of emotional lability. The objectives of the trial are to examine the safety and effectiveness of Neurodex in treating pseudobulbar effect, also known as emotional lability or pathological laughing or crying, a symptom experienced by an estimated 1 million people with certain neurological conditions. Avanir said Neurodex, an orally administered combination of dextromethorphan and an enzyme inhibitor, is the first drug product specifically targeted to the treatment of emotional lability.
Battelle Pulmonary Therapeutics Inc., of Columbus, Ohio, changed its name to BattellePharma, saying the new moniker emphasizes its position as a specialty pharmaceutical company. BattellePharma has a portfolio of nine products in development, with several in early clinical trials, to treat a variety of respiratory and systemic diseases and lung cancer.
Biopolymer Engineering Inc., of Eagan, Minn., reported research demonstrating the survival rate among mice treated with injected WGP Beta Glucan two days before infection with a lethal dose of anthrax spores increased from 30 percent in the control group to more than 80 percent in the treatment group. The survival rate among mice orally treated daily with WGP Beta Glucan for seven days before infection increased from 50 percent in the control group to 100 percent. The survival rate of mice treated therapeutically, or post-infection, increased to 90 percent, compared with 30 percent among controls.
Cellegy Pharmaceuticals Inc., of South San Francisco, released at the American Association for Cancer Research meeting in San Francisco positive study results on the involvement of nitric oxide and cGMP (cyclic guanosine monophosphate) mimetics in attenuating the metastasis of cancer cells. Previously, it was reported that cancer cells (human breast cancer cells, MDA-MB-231 and mouse melanoma cells, B16F10) made resistant to chemotherapeutic agents, 5-fluorouracil and doxorubicin by hypoxia, can be resensitized if the cells are exposed to nitroglycerin, a nitric oxide donor. New results demonstrated both nitric oxide donors and the cGMP signaling pathway are involved in the regulation of an invasion-associated cell surface molecule (urokinase receptor) as well as metastasis.
Cytyc Corp., of Boxborough, Mass., extended its offer to purchase for cash and stock all of the outstanding shares of common stock of Digene Corp., of Gaithersburg, Md., to midnight April 25, unless further extended. Prior to the extension, the exchange offer had been scheduled to expire April 11. Aside from this extension, the terms and conditions of the exchange offer remain in effect and unmodified. (See BioWorld Today, Feb. 20, 2002.)
EGeen International Corp., of Redwood City, Calif., announced the completion of a $2 million private placement financing led by the SEAF CEE Growth Fund, of Washington, and The Baltics Small Equity Fund, of Estonia. EGeen has exclusive commercial rights to information from the Estonian Gene Bank. Co-investors include Steve Jurvetson, managing director of Draper Fisher Jurvetson, and Ned Oliver, general partner of Oxford Bioscience Partners. EGeen will use the initial funding to build the gene bank and to develop a U.S. staff focusing on corporate development.
Genmab AS, of Copenhagen, Denmark, and Paradigm Therapeutics Ltd., of Cambridge, UK, entered a broad-based collaboration to develop antibody therapeutic products for a range of disease areas, including cancer and inflammatory diseases. The partnership will use commercially promising disease targets discovered in Paradigm’s research combined with Genmab’s fully human antibody technology to create and develop new products. Genmab and Paradigm will collaborate on the research, development and commercialization of the new antibody products and will share development costs and revenues generated from out-licensing or sales of resulting products.
Genta Inc., of Berkeley Heights, Calif., reported publication of data suggesting that survival was prolonged in a group of patients receiving chemotherapy for multiple myeloma who also received additional therapy with low-dose gallium nitrate, Genta’s lead compound from its Gallium Products franchise. The paper was published by investigators from the Weill Medical College of Cornell University, and appears in the current issue of Leukemia and Lymphoma. A retrospective analysis compared 13 gallium-treated patients with 167 control patients who received similar chemotherapy only. Median survival in the gallium-treated patients was 87-plus months, whereas survival in the control group was 48 months.
Gyros AB, of Uppsala, Sweden, said Schroder Ventures Life Sciences, of London, joined other investors and added $6 million to the company’s second-round funding. That brought the total raised in the round to approximately $36 million. Gyros recently released the Gyrolab Maldi SP1 and the Gyrolab Workstation, products designed to increase productivity by streamlining conventional applications into single, nanoliter-scale procedures. (See BioWorld Today, Dec. 18, 2001.)
Introgen Therapeutics Inc., of Austin, Texas, presented data at the annual meeting of the American Association for Cancer Research from two preclinical studies that demonstrated INGN 251 inhibits the growth of melanoma and colorectal cancer cells. INGN 251 is a gene therapy product that produces high levels of the PTEN protein. Separately, the Univeristy of Texas M.D. Anderson Cancer Center said at the meeting that, in addition to the mda-7 gene’s known activity as a tumor suppressor, the therapeutic component of Introgen’s INGN 241 gene therapy product candidate can also stimulate the body’s immune system to protect it against cancer.
Nymox Pharmaceutical Corp., of Maywood, N.J., said it entered an agreement with the Massachusetts General Hospital at Harvard University to license certain patent rights with respect to novel cancer markers that have potential applications in the treatment and diagnosis of specific cancers. Nymox is developing treatments for enlarged prostate and has several antibacterials in development. Financial terms were not disclosed.
Oncolytics Biotech Inc., of Calgary, Alberta, received approval from Health Canada to initiate a Phase I/II trial to investigate the use of Reolysin as a treatment for patients with recurrent malignant glioma, the most aggressive form of brain cancer. In the dose-escalation, or Phase I portion of the trial, patients with a variety of recurrent malignant gliomas will be enrolled. In Phase II, patients with recurrent glioblastoma multiforme, the most aggressive glioma, will be treated with dosages determined by the results of the dose-escalation study. Up to 40 patients are expected to be enrolled.
Pilot Therapeutics Holdings Inc., of WinstonSalem, N.C., entered into an agreement with Ancile Pharmaceuticals Inc., of San Diego. Ancile initially will provide specialized technical assistance for Pilot to prepare and file its investigational new drug applications for two of its botanical drug candidates, PLT 1731 for the treatment of asthma and PLT 732 for the treatment of elevated triglycerides associated with heart disease and stroke. Botanicals with a documented history of safe human use generally may enter Phase II or III trials, with greatly reduced preclinical documentation. Financial terms were not disclosed.
Progen Industries Ltd., of Brisbane, Australia, signed a manufacturing contract worth more than $267,000 with Lipid Sciences Inc., of Pleasanton, Calif. Progen is responsible for manufacturing and clinical support for Lipid’s Phase I trial. Progen will process human plasma samples taken from healthy volunteers with elevated plasma cholesterol and will provide local management oversight for the trial.
Structural GenomiX Inc., of San Diego, earned its first milestone payment award from Cystic Fibrosis Foundation Therapeutics Inc., of Bethesda, Md., the drug discovery and development arm of the Cystic Fibrosis Foundation. The award was made in connection with Structural’s progress in solving the 3-dimensional structure of a complex protein called cystic fibrosis transmembrane conductance regulator, which, when defective, causes CF. The first milestone aids in understanding where many of the mutations occur, providing important structural insight into the mutant protein.
SuperGen Inc., of Dublin, Calif., released at the American Association for Cancer Research annual meeting in San Francisco results of a clinical study demonstrating the anticancer drug decitabine’s ability to alter the process of gene methylation, a component in cancer growth. The Phase I study enrolled 10 patients diagnosed with solid tumors who were given a seven-day continuous infusion of decitabine, which was well tolerated and resulted in specific changes in gene promotor methylation. Another study showed hypermethylated tumor suppressor genes in 64 percent of tumor tissue taken from 90 patients with early stage non-small-cell lung cancer. Separately, American Pharmaceutical Partners Inc., of Los Angeles, entered into an exclusive sales and distribution agreement with SuperGen for generic mitomycin. American Pharmaceutical will be the exclusive U.S. marketer to the hospital market, including group purchasing organizations and their affiliates, alternate care sites, as well as federal and state government entities. Mitomycin, a lyophilized product, is used in the treatment of adenocarcinoma of the stomach and pancreas in combination with other approved chemotherapeutic agents, and is the generic equivalent of Mutamycin, which belongs to Bristol-Myers Squibb Co., of New York.
Targeted Genetics Corp., of Seattle, reported promising data from preclinical studies using an adeno-associated virus (AAV) vector for a novel AIDS vaccine candidate, at the Keystone conference in Keystone, Colo. Following a single injection of rAAV/IgG1b12, mice were analyzed over six months to assess gene transfer, gene expression and the ability to block HIV-1 infection. The highest concentrations were observed three months after injection and were then sustained over the next three months. Also, 90 percent of the test samples possessed detectable neutralization, or blocking, activity. No adverse events attributable to the injection procedure were seen.
Telik Inc., of South San Francisco, began a Phase II trial of its TLK286 product candidate in breast cancer, the first TLK286 Phase II trial in breast cancer as well as the first Phase II trial in which TLK286 is being administered on a weekly dose schedule. The multicenter, open-label study is in patients with metastatic breast cancer who have become refractory to chemotherapy or have not yet received chemotherapy. The endpoints of the study are objective tumor response rate, time to tumor progression and safety. The candidate already is in Phase II for colorectal, ovarian and non-small-cell lung cancer.