¿ Aastrom Biosciences Inc., of Ann Arbor, Mich., and BioWhittaker Inc., of Walkersville, Md., initiated a co-marketing alliance for their cell therapy products. The companies will market Aastrom¿s Dendricell products and BioWhittaker¿s X-Vivo cell culture media. The products can be used together to produce human dendritic cells for cell-based cancer vaccines. BioWhittaker¿s line of X-Vivo serum-free media will be custom packaged to provide synergy with Aastrom¿s Dendricell products.
¿ Agilent Technologies Inc., of Palo Alto, Calif., and Maxim Biotech Inc., of South San Francisco, formed a co-marketing agreement involving Agilent¿s 2100 Bioanalyzer with DNA LabChip kits and Maxim¿s multiplex PCR reagents. The companies said this combination of products provides biochemists with the ability to more easily, quickly and accurately conduct experiments involving the analysis of several genes.
¿ Alliance Pharmaceutical Corp., of San Diego, said that it and Baxter Healthcare Corp., of Deerfield, Ill., met with the FDA regarding the continuing clinical development of Oxygent, an intravascular oxygen carrier intended to reduce the need for donor blood. A Phase III cardiac surgery study was voluntarily suspended earlier this year due to certain adverse events that the companies concluded were not directly related to Oxygent, but resulted from procedures specified in the protocol. A final report will be submitted to the FDA later this year, with a new Phase III study planned. Additionally, Baxter made payments to Alliance totaling $7 million in May, and made a $4 million investment in Alliance Series F preferred stock Thursday. The companies have agreed to restructure the remaining $19 million stock purchases originally scheduled for 2001 in order to reflect the timeline revisions in the clinical and regulatory plans. The $19 million obligation will be paid upon the occurrence of certain milestones during the development of the new pivotal trial protocol and the conduct of the study. Alliance¿s stock (NASDAQ:ALLP) gained 41 cents Thursday, or 28.5 percent, to close at $1.85. (See BioWorld Today, March 14, 2001.)
¿ BioxelPharma Inc., of Sainte-Foy, Quebec, said the exchange of its shares for shares of Richcor Resources Ltd., of Vancouver, British Columbia, was completed Tuesday on the scheduled basis of 1,322 common shares of Richcor for each common share of Bioxel. Following this merger, shareholders of Richcor will hold about 9 percent of the roughly 29.2 million Bioxel outstanding shares, while the founding shareholders of Bioxel and the investors who participated in the private placement of the special warrants of Bioxel will hold about 58.5 percent and 32.5 percent, respectively. Shares of Bioxel will be listed on the Canadian Venture Exchange under the symbol BIP, and it expects to begin trading on or about Aug. 13.
¿ Cell Therapeutics Inc., of Seattle, said a study by researchers at the University of Miami School of Medicine showed that arsenic trioxide in combination with ascorbic acid may overcome or circumvent the major resistance mechanisms found in multiple myeloma cells. The conclusions of the study were published in a recent issue of Blood. Trisenox, marketed by Cell Therapeutics, is a pharmaceutical grade of arsenic trioxide that has been approved by the FDA to treat patients with relapsed or refractory acute promyelocytic leukemia.
¿ CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said the AIDS Malignancy Consortium, sponsored by the National Cancer Institute, opened enrollment for a multicenter study to determine the efficacy of COL-3 (Metastat), an orally active angiogenesis inhibitor developed by CollaGenex for HIV-related Kaposi¿s sarcoma. The Phase II trial is expected to enroll 70 patients with HIV-related KS at two dose levels. The primary objectives of the study are to evaluate the tumor response rate and response duration, as well as to evaluate the biologic activity of Metastat by measuring serum levels of pro-angiogenic mediators.
¿ Compugen Ltd., of Tel Aviv, Israel, formed an agreement with Novartis AG, of Basel, Switzerland, to use Compugen¿s technology services to accelerate identification of drug targets based on the analysis of fundamental gene and protein data. Terms were not disclosed. Novartis will use Compugen¿s LEADS computational biology platform to create a database that will detail gene expression at the level of RNA. Additionally, Compugen will provide Novartis with a proprietary DNA chip design that will represent Novartis¿ transcriptome database. Novartis said researchers will use the gene chips to detect which of the thousands of genes are expressed in various diseases, allowing the company to identify drug therapies that address specific targets.
¿ DNAPrint genomics Inc., of Sarasota, Fla., was awarded a High Tech Corridor grant by the University of South Florida Office of Economic Development. The grant provides $305,000 over the next year for the development of a model system for defining the genetic variance components that underlie variable drug response. The company said it will use the model system to guide and validate its large-scale population genetics research and product development efforts.
¿ Eli Lilly and Co., of Indianapolis, and Syncor International Corp., of Woodland Hills, Calif., formed a partnership to provide an emergency response delivery service for Xigris, Lilly¿s investigational biotechnology compound for the treatment of severe sepsis. The service will be the first nationwide distribution system to provide a pharmaceutical product within three hours to most hospitals. Lilly¿s new drug application for Xigris is under priority review by the FDA.
¿ Emisphere Technologies Inc., of Tarrytown, N.Y., reported the demonstration of the oral delivery of a parathyroid hormone fragment (PTH) in multiple animal models. The study was conducted by Emisphere and Eli Lilly and Co., of Indianapolis, with promising results, it said. A recombinant version of PTH (1-34), a drug known to stimulate bone formation, currently is being developed for osteoporosis in an injectable formulation by Lilly, under the name Forteo. In nonhuman primates administered an oral solution containing PTH and Emisphere¿s delivery agent 4-MOAC, serum PTH concentrations were comparable to levels observed following subcutaneous injection and were significantly enhanced above levels observed when PTH was administered orally alone. Lilly¿s new drug application for Forteo is under review at the FDA.
¿ Endorex Corp., of Chicago, through its acquisition of Corporate Technology Development Inc., of Miami, expanded its pipeline by taking on CTD¿s two drugs, orBec and Oraprine. orBec is in a multicenter Phase III trial for intestinal graft-vs.-host disease (GVHD). The compound is an oral dual-release formulation of beclomethasone dipropionate. Oraprine is a liquid formulation of azathioprine and it has completed a pilot Phase I/II trial for the treatment of chronic oral autoimmune diseases, such as GVHD. Oraprine has been given orphan drug status for GVHD. The all-stock deal initially was valued at about $10.3 million.
¿ Genencor International Inc., of Palo Alto, Calif., and the Centre for Applied Microbiology & Research, of London, entered a collaboration to develop technology to eliminate prions. Prions are believed to be the infectious agents that cause bovine spongiform encephalopathy, also known as mad cow disease, and its human form, Creutzfeld-Jakob disease. The two-year collaboration is focused on an enzyme-based process for treating surgical equipment, rendered animal material and blood products to eliminate prion infectivity. The partnership also will investigate developing an effective rapid-detection test.
¿ IDEC Pharmaceuticals Corp., of San Diego, said the FDA formally acknowledged receipt of the July 9 resubmission of its biologics license application for Zevalin and has characterized the resubmission as complete. The drug ¿ designed for the treatment of relapsed or refractory low-grade follicular CD-20-positive transformed B-cell non-Hodgkin¿s lymphoma ¿ will be reviewed by the Oncologic Drugs Advisory Committee on Sept. 11.
¿ Kosan Biosciences Inc., of Hayward, Calif., was awarded a Phase I Small Business Innovation Research grant from the National Cancer Institute. The grant was awarded to Kosan to develop an efficient means of producing the polyketide discodermolide, a potential anticancer agent. Discodermolide has been shown by researchers to inhibit cancer cells by the same mechanism as paclitaxel, but also is effective against paclitaxel-resistant tumors.
¿ Micrologix Biotech Inc., of Vancouver, British Columbia, completed enrollment of 75 patients for its Phase II trial in the U.S. for MBI 594AN, a drug candidate for acne. The company said the last subjects should complete treatment by mid-September, with trial results expected before the end of November. The trial is a randomized, double-blind, placebo-controlled, dose-ranging study.
¿ Pharmacyclics Inc., of Sunnyvale, Calif., completed patient enrollment in a Phase II trial to evaluate its lead investigational product, Xcytrin (motexafin gadolinium) injection, for the treatment of glioblastoma multiforme (GBM), or primary brain tumor. A total of 24 newly diagnosed GBM patients were enrolled at eight medical centers in a single-arm study designed to evaluate the safety and pharmacokinetics of a six-week treatment course of Xcytrin combined with a standard six-week course of radiation therapy. The company expects to complete analysis of its safety data by the fourth quarter. If the results are favorable, Pharmacyclics plans a Phase III trial early next year.
¿ Progen Industries Ltd., of Brisbane, Australia, reported enrolling the first two patients in a Phase I/II trial of its anticancer drug PI-88. The trial will be conducted in two phases at the University of Colorado Health Sciences Center.
¿ Prospect Ventures Partners, of Palo Alto, Calif., closed its second fund, Prospect Venture Partners II, at $500 million. It is earmarked for life science and medical technology companies. The prior fund, Prospect Venture Partners I, was a $100 million fund invested in a number of companies, including Senomyx Inc., of La Jolla, Calif.; Signature Biosciences Inc., of Hayward, Calif.; and Structural Genomix Inc., of San Diego.
¿ SurroMed Inc., of Mountain View, Calif., was awarded a Small Business Innovation Research grant from the National Institutes of Health. The funding will support development of the company¿s Nanobarcode identification tag technologies for use with multiplexed immunoassays for mouse phenotyping. The grant amount was not disclosed.
¿ Tanox Inc., of Houston, reported positive results using TNX-224, its anti-factor D monoclonal antibody, to reduce inflammatory responses in an experimental model of cardiopulmonary bypass. In the study, TNX-224 was added to freshly collected blood from five healthy donors and recirculated through a pediatric cardiopulmonary bypass circuit to mimic the condition of open-heart surgery procedures. Researchers reported that TNX-224 effectively inhibited the activation of complement, neutrophils and platelets. The data suggest that inhibition of complement activation by TNX-224 could be useful in reducing systemic inflammation in patients undergoing cardiopulmonary bypass.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., began enrollment for a Phase I trial of its investigational anticancer agent Triapine in combination with the anticancer agent gemcitabine, for patients with advanced and metastatic cancers. Two different schedules of the Triapine and gemcitabine combination will be explored in the trial, which is designed to measure the safety and maximum tolerated doses of the agents in each schedule. A total of 20 to 40 patients is expected.
¿ Vysis Inc., of Downers Grove, Ill., received FDA clearance to market its UroVysion test for monitoring recurrence of bladder cancer. The test is based on the detection of genetic changes in bladder cells using the company¿s fluorescence DNA probe technology. According to Vysis, the assay is the industry¿s first genomic DNA-probe test for monitoring recurrence of bladder cancer to be cleared for marketing by the FDA. Vysis¿ stock (NASDAQ:VYSI) gained $2.65 Thursday, or 11 percent, to close at $26.65.