¿ Antex Biologics Inc., of Gaithersburg, Md., completed lab analyses of its Phase Ib trial of Helivax, an oral vaccine intended to prevent and treat gastrointestinal infections and disease caused by Helicobacter pylori. The vaccinated volunteers were positive for immune cell proliferation, cytokine production and secretory IgA antibodies. The results provide the basis for proceeding to a Phase II trial, which will be conducted in early 2002, Antex said.
¿ AtheroGenics Inc., of Atlanta, said its board of directors adopted a shareholders rights plan declaring a dividend distribution of one common stock purchase right on each outstanding share of its common stock. The action is designed to protect the interests of shareholders in the event of a proposed takeover. The company said it is not aware of any such attempts.
¿ AVAX Technologies Inc., of Kansas City, Mo., received a warning letter from the Division of Inspections and Surveillance of the FDA. The letter, which related to the FDA inspection of the company¿s manufacturing facility in April and May, notified AVAX that the agency considers certain manufacturing and clinical practices to be in violation of the regulations governing the proper conduct of clinical studies involving investigational new drugs. AVAX must respond within 15 days of receiving the letter. In a related decision, at the recommendation of the FDA, AVAX placed its existing INDs on inactive status. (See BioWorld Today, April 24, 2001, and Sept. 24, 2001.)
¿ Endovasc Ltd., of Montgomery, Texas, said it is encouraged following meetings with the FDA regarding Liprostin and Nicotine Receptor Agonist. The FDA agreed to simplify Liprostin¿s Phase III protocol for treating critical limb ischemia, and agreed to the company¿s plan to begin Phase III trials of NRA for chronic coronary ischemia. Endovasc plans to submit a revised Liprostin Phase III protocol to the FDA by the end of this month, allowing the first patient to be treated in early January 2002. And it anticipates that Phase III NRA trials could begin in the first quarter of 2002.
¿ Genentech Inc., of South San Francisco, said its board authorized the repurchase of up to $625 million of its common stock over the next 12 months. Genentech plans to use the repurchased stock to offset dilution caused by the issuance of shares in connection with Genentech¿s employee stock plans. As of Oct. 31, Genentech had about 527,890,384 shares of common stock outstanding.
¿ Gilead Sciences Inc., of Foster City, Calif., announced preliminary results from a Phase II trial, Study 461, evaluating the efficacy and safety of adefovir dipivoxil at 10 mg once daily in patients with lamivudine-resistant chronic hepatitis B virus infection and compensated liver disease. In a planned interim analysis, patients receiving adefovir dipivoxil monotherapy and patients receiving it in combination with lamivudine daily exhibited a time-weighted average decrease in serum HBV DNA from baseline of 2.46 log10 copies/mL and 2.45 log10 copies m/L, respectively, compared to a decrease in time-weighted average serum HBV DNA of 0.07 log10 copies/mL for patients receiving lamivudine monotherapy (p<0.001). There was no difference in the frequency of adverse events across treatment groups. Gilead plans to file for an NDA in the first half of next year. (See BioWorld Today, June 25, 2001; Sept. 5, 2001; and Sept. 20, 2001.)
¿ Pharmacia Corp., of Peapack, N.J., reduced its shareholding in Biovitrum AB, of Stockholm, Sweden, to 19 percent through the sale of shares in the new biotechnology company to two venture capital institutional investors, Alta Partners, of San Francisco, and HBM Ventures, of Switzerland. Upon closing of the initial external financing agreement establishing Biovitrum on July 31, Pharmacia owned about 35 percent of the company.
¿ Juvenile Diabetes Research Foundation International, of New York, granted $15 million toward the opening of a clinical center at the University of Alberta to study the treatment of juvenile diabetes through islet transplantation. The five-year grant is intended for research into furthering the advances of the Edmonton Protocol diabetes research, which established a set of procedures for islet transplantation from donor pancreases that can restore normal insulin production in people with Type I diabetes.
¿ Maxim Pharmaceuticals Inc., of San Diego, said Ceplene (histamine dihydrochloride) was shown in a preclinical study to protect critical immune cells commonly found in the liver against programmed cell death, thereby preserving the ability of these immune cells to kill malignant cells and virally infected cells. Human natural killer, T and liver-type NK/T cells were shown to be sensitive to reactive oxygen species-induced apoptosis when these immune cells were exposed to phagocytes.
¿ Myriad Genetics Inc., of Salt Lake City, said late Friday that it filed a shelf registration statement with the Securities and Exchange Commission for the sale of up to $250 million of various types of securities.
¿ OraPharma Inc., of Warminster, Pa., common stock purchasers have had a class action lawsuit filed on their behalf for purchases between March 9, 2000, and Dec. 6, 2000. The action is pending in the U.S. District Court, Southern District of New York, against defendants OraPharma, certain of its officers and underwriters. Separately, a class action lawsuit was filed on behalf of purchasers of the securities of Noven Pharmaceuticals Inc., of Miami, between March 27, 2001, and Nov. 1, 2001. The action is pending in the U.S. District Court, Southern District of Florida, against Noven president, co-chairman and CEO Robert Strauss and other officers.
¿ SuperGen Inc., of Dublin, Calif., said data from an ongoing Phase I study of its anticancer compound decitabine showed encouraging and objective responses in more than half, or 24 out of 42, of the patients, yet at very low dosages of one-third to one-tenth of the maximum tolerated dosing schedules established in various European clinical studies. The data were presented at the 19th annual symposium on Innovative Cancer Therapy for Tomorrow in New York.
¿ Synsorb Biotech Inc., of Calgary, Alberta, was granted an additional 200,000 common shares of BCY LifeSciences Inc., of Toronto. This second milestone of 200,000 shares was triggered by Health Canada¿s approval to begin Phase I trials in September, which have since completed enrollment. An additional 400,000 common shares would be issued to Synsorb subject to the completion of other predetermined milestones.
¿ Vernalis Group plc, of London, said the FDA approved frovatriptan for sale in the U.S. for the acute treatment of migraine. Controlled studies at the approved dose of 2.5 mg showed that frovatriptan has a prolonged presence in the bloodstream and that few migraine patients experienced a recurrence of headache within a 24-hour period of taking the drug. Vernalis¿ U.S. marketing partner, Elan Corp. plc, of Dublin, Ireland, which licensed exclusive North American sales and distribution rights for the drug in October 1998, is in discussions with potential co-promotion partners.
¿ Wilex AG, of Munich, Germany, will co-develop and have first rights for the therapeutic use of disease markers and new cancer targets discovered by Germany¿s newly established Proteomics Consortium, which consists of Wilex and a number of academic collaborators and partner companies. The technology will be applied to the identification of new tumor markers, new prognostic markers and new therapy targets.