¿ AltaRex Corp., of Waltham, Mass., said preliminary results of a Phase I dose comparison study with BrevaRex MAb, a murine monoclonal antibody for the treatment of patients expressing the tumor-associated antigen MUC1, show treatment was generally well tolerated and there was no limiting toxicity of any of the dose levels tested. The study tested 17 patients, primarily with late-stage breast cancer. Four out of five patients exhibited stabilization or decrease in MUC1 at the 2 mg dose level.
¿ Antigen Express Inc., of Worcester, Mass., received a $173,000 Small Business Innovation Research grant from the National Institutes of Health to support continued development of a novel genetic colon cancer vaccine based on the modulation of MHC Class II molecule expression.
¿ Antigenics Inc., of New York, initiated a Phase II trial testing Oncophage cancer vaccine in patients with non-Hodgkin's lymphoma. It will be open to up to 35 patients who have been diagnosed with a variety of the lymphomas.
¿ Celera Genomics, of Rockville, Md., and City of Hope Cancer Center in Duarte, Calif., entered a collaboration to investigate associations of genetic polymorphisms with breast cancer. Celera retains the rights to use all information generated in its database products. All intellectual property developed through the collaboration will be jointly owned by Celera and City of Hope.
¿ Connetics Corp., of Palo Alto, Calif., received a $5 million payment for completion of the manufacturing scale-up of ConXn (recombinant human relaxin) from pilot lots to commercial quantities. The payment was issued by a U.S. subsidiary of Celltech Group plc, of Slough, UK, as part of a license agreement entered into by Medeva plc, of London. Under terms of the agreement, Celltech will exclusively market the compound in Europe and may co-promote it for up to five years with Connetics in the U.S. Connetics is conducting a pivotal Phase II/III trial with ConXn for the treatment of scleroderma. It expects to file a biologics license application in 2001.
¿ Endorex Corp., of Chicago, said certain stock dividend and antidilution rights provided to investors in the company's October 1997 private placement terminated on Monday. The company is able to terminate the rights based upon its recent stock price performance, which triggered termination provisions. The dividend was established to provide shareholders with a minimum return if shares failed to reach a targeted level of $4.63 each, but the level was recently exceeded. The company registered to sell about 2.2 million shares in December. About 420,000 shares were issued, but due to the termination of the dividend rights, none remaining will be issued.
¿ Epix Medical Inc., of Cambridge, Mass., plans to present preliminary Phase II clinical results at the April meeting of the American Association for Cancer Research in San Francisco. The results demonstrate the potential for magnetic resonance imaging when enhanced with AngioMARK (MS-325) to provide an improved tool for non-invasive detection of breast lesions. AngioMARK is in Phase III trials for aortoiliac occlusive disease.
¿ Gilead Sciences Inc., of Foster City, Calif., and Fujisawa Healthcare Inc., of Deerfield, Ill., said AmBisome (amphotericin B) liposome for injection, an antifungal agent, received marketing approval in Canada. It will be marketed to treat systemic or disseminated infections due to Candida, Aspergillus or Cryptococcus in patients who are refractory to or intolerant of conventional amphotericin B therapy, or patients who have renal impairment.
¿ Gliatech Inc., of Cleveland, said company scientists obtained data showing that an antiproperdin monoclonal antibody is effective at reducing inflammation in a rabbit model of immune complex deposition. The presence of immune complexes in the body has been suggested to lead to inflammatory conditions such as rheumatoid arthritis, lupus and nephritis.
¿ Hemispherx Biopharma Inc., of Philadelphia, said it filed charges against Asensio & Co. Inc., of New York, in the Eastern District Federal Court of Pennsylvania in Philadelphia for alleged defamation, disparagement and interference with contractual relations. The company also said a federal court imposed a fine on Asensio of $1,000 a day for failure to cooperate in various demands by the federal judiciary. Hemispherx described Asensio as a "short-seller." Asensio issued a press release Friday saying Hemispherx essentially lied about presenting HIV test findings at a conference sponsored by Boston-based Search For a Cure. Asensio, a member of the National Association of Securities Dealers, said a letter written by the Search For A Cure founder and chairman said Hemispherx did not make a presentation and its requests to make a presentation were turned down. It further stated that Hemispherx press releases seemed to imply a false endorsement by Search For A Cure. Hemispherx said the material was, in fact, presented at the conference, but by University of California, Irvine, researchers, and not by company officials.
¿ Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said it closed on the final placement of convertible preferred shares with Aventis Pharma, the pharmaceutical company of Aventis SA, of Frankfurt, Germany, for net proceeds of C$5.8 million (US$4 million). Proceeds will be used to fund the development of Inflazyme's IPL576 series in asthma and Aventis Pharma's treatment for allergies. The placement is part of a February 1999 deal between Inflazyme and Aventis, formerly Hoechst Marion Roussel Inc. (See BioWorld Today, Feb. 10, 1999, p. 1.)
¿ Integra LifeSciences Holdings Corp., of Plainsboro, N.J., said a federal jury hearing the case Integra LifeSciences I Ltd. and The Burnham Institute vs. Merck KgaA, of Darmstadt, Germany, returned a unanimous verdict finding that Merck had willfully infringed and induced the infringement of Integra's patents. The jury awarded Integra $15 million in damages. The lawsuit, filed in 1996, alleged that Merck infringed various patents held by The Burnham Institute, of San Diego, that were licensed to Integra. Those patents related to technology involving peptides containing an arginine-glycine-aspartic acid sequence, or related cell surface receptors.
¿ Isis Pharmaceuticals, of Carlsbad, Calif., and The University of Washington School of Medicine said Isis has joined the university's Cell System's Initiative (CSI) program. CSI is a research and educational program with the mission to understand in detail how cellular systems behave.
¿ Medinox Inc., of San Diego, said researchers at the Medical College of Wisconsin in Milwaukee used a novel combination therapy of NOX-100 and cyclosporine A (CsA) as a new therapeutic approach to prevent rejection of transplanted organs. The studies showed that the combination therapy allowed long-term survival of transplanted organs, as well as reduced the CsA dose needed to prevent rejection by 75 percent.
¿ Micrologix Biotech Inc., of Vancouver, British Columbia, closed on its $40 million financing. The private placement involved a total of 4 million special warrants issued at $10 each. Each warrant entitles the holder to acquire one common share of Micrologix. (See BioWorld Today, March 10, 2000, p. 4.)
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., signed an agreement for an expanded alliance with MorphoSys AG, of Munich, Germany. MorphoSys will apply its HuCAL technology to generate human antibodies for a new target molecule in inflammatory disorders provided by Millennium. Millennium has the right to apply the technology to six additional targets. MorphoSys receives an up-front payment and research and development funding, as well as milestone payments.
¿ ML Laboratories, of London, said evidence indicates that Dexemel provides significant benefits when used to deliver certain gene therapy products. Dexemel is a sterile solution of ML's patented osmotic agent icodextrin, which allows drugs to be administered via the periotoneal cavity enabling those drugs to be delivered locally in the abdomen and targeted to the lymphatic system and liver.
¿ Steroidogenesis Inhibitors International Inc., of Las Vegas, said it will begin a new clinical trial at Georgetown University Medical Center to demonstrate that Anticort acts by inhibiting adrenal cortisol synthesis, thus lowering the circulating cortisol levels in the blood. Consequently, Anticort then modulates the immune response of infected individuals, leading to a more effective response to HIV and other autoimmune diseases.
¿ Synsorb Biotech Inc., of Calgary, Alberta, said it received 1.1 million common shares in BCY Ventures Inc., of Toronto, as part of an agreement in which Synsorb assigned to BCY its license of certain technologies relating to the treatment of lung complications associated with cystic fibrosis. BCY issued 800,000 common shares under the agreement, as well as 300,000 common shares issued under a separate consulting agreement in which Synsorb will continue to act as a resource in the development of the assigned technologies. An additional 800,000 common shares will be issued following successful completion of predetermined milestones. When completed, Synsorb will own about 21.77 percent of the issued and outstanding shares of BCY.
¿ The Institute for Genomic Research, of Rockville, Md., said scientists completed the DNA sequencing of the Chlamydia trachomatis MoPn and Chlamydia pneumoniae AR39 genomes. Their findings will allow researchers new insight into the genes responsible for causing a range of serious human infections.