¿ Aastrom Biosciences Inc., of Ann Arbor, Mich., started a program to develop its cell production technology and AastromReplicell System in the treatment of bone-related diseases. The program is intended to result in a new therapy kit for use with the AastromReplicell System, which will be designed to produce therapeutic quantities of bone-forming cells to aid in the treatment of bone degenerative diseases such as osteoporosis.
¿ Affymetrix Inc., of Santa Clara, Calif., introduced its first GeneChip Probe array product for the measurement and analysis of gene expression in a prokaryotic organism. The product allows the simultaneous measurement of more than 4,200 Escherichia coli genes in a single analysis. Along with the array will be a method for sample preparation with potential use for all prokaryotic messenger RNAs.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., said Pharmacia & Upjohn Co., of Bridgewater, N.J., is the new marketing partner for its periodontal therapy for companion animals, which is currently being marketed by the Heska Corp., of Fort Collins. Pharmacia & Upjohn Animal Health will assume the existing license agreement and start marketing the product. Atrix's technology is used in the delivery of the Perioceutic gel product.
¿ Biohybrid Inc., of Denver, said its engineered veto approach is able to block immune responses to foreign tissue in an animal model. Biohybrid produced a gene transfer vector selectively to remove unwanted immune responses.
¿ CollaGenex Pharmaceuticals Inc., of Newtown, Pa., released initial findings that showed Metastat, its lead anti-angiogenesis compound for the treatment of cancer, was well tolerated at the lowest dose level tested, and that antitumor activity was observed at all dose levels. The results will be presented at the 2000 International AIDS Malignancy conference in May. The Phase I study was done with patients with HIV-associated Kaposi's sarcoma, many of whom had received prior therapy. The study was carried out by the AIDS Malignancy Consortium, sponsored by the National Cancer Institute.
¿ Generex Biotechnology Corp., of Toronto, started clinical trials of Oralin/Oralgen, its oral insulin formulation, in newly diagnosed diabetic patients. The trial is at the University of Perugia in Italy. The trial's purpose is to study the efficacy and effectiveness of oral insulin on patients who have not yet been treated with oral agents and/or insulin injections.
¿ Genetronics Biomedical Ltd., of San Diego, reported results of the extension of its platform technology, electroporation, into gene therapy. Electroporation therapy involves the application of pulsed electric fields to any target tissue. In addition, the company signed its fifth corporate agreement in the area of gene therapy.
¿ La Jolla Pharmaceutical Co., of San Diego, presented the methods and results of a blood test used in analyzing data from its recent lupus clinical trials. The test measures the strength of the binding between a patient's antibodies to double-stranded DNA and the company's lupus drug, LJP 394. The test's approach enables real-time binding measurements without radioactive labeling of biomolecules such as antibodies. In these studies, the company was able to show that the approach can measure the average binding affinity of polyclonal antibodies in a repeatable manner and validated a mathematical model of the molecular interaction.
¿ Martek Biosciences Corp., of Columbia, Md., and Abbott Laboratories, of Abbott Park, Ill., signed a non-exclusive license agreement for Martek's technology relating to the use of long-chain polyunsaturated fatty acids in infant formulas. The agreement calls for initial cash payments and would give Martek an ongoing royalty upon Abbott's introduction of products using Martek's technology for docosahexaenoic acid and arachidonic acid.
¿ Matrix Pharmaceutical Inc., of Fremont, Calif. submitted the initial section of a new drug application (NDA) for IntraDose. Matrix expects to unblind its two pivotal head and neck cancer clinical studies and report initial results in late May. At that time the company will evaluate the data and determine the strategy for filing a complete NDA. A complete filing could be submitted by the end of the year.
¿ Nastech Pharmaceutical Co., of Hauppauge, N.Y., said that the use of intranasal morphine was successful in comparison to placebo in a third-molar extraction dental trial. In the double-blind, placebo-controlled trial, 52 patients were randomized to treatment that consisted of intranasal morphine, intramuscular morphine or placebo. The intranasal formulation produced total pain relief scores over four hours of 2.6 compared to 1.7 using placebo. Data indicate that the efficacy of intranasal morphine was about 75 percent of intramuscular morphine at 30 minutes after administration.
¿ NewBiotics Inc., of San Diego, closed a $6.3 million private placement that will be used to advance preclinical testing of its lead drug, NB1011, as well as expand its product portfolio into additional cancer and infectious disease applications. The NB1011 compound is part of the core enzyme catalyzed therapeutic activation technology that focuses on the treatment of drug resistance in colon and breast cancers. The financing was led by IngleWood Ventures, and includes investments from J.F. Shea Co. Inc., of Walnut, Calif.; Nevada-based HMCH Ventures; and Life Science partners, of Amsterdam, the Netherlands.
¿ Novopharm Biotech Inc., of Toronto, said that the Dan Family Holdings Ltd. (DFH) established an ongoing funding for up to C$12 million, with the first tranche being a C$5 million (US$3.4 million) private placement equity investment. In consideration of this investment DFH received 6.8 million units of stock at C73 cents each, which was the closing price of the stock on Thursday. Each unit consists of one common share of stock and one-half common share purchase warrant. The second tranche will be in the form of non-interest bearing facility, which may be utilized up to the maximum of C$7 million.
¿ Nuerocrine Biosciences Inc., of San Diego, said Phase II results of NBI 5787 demonstrated clinical benefit in the low-dose group in patients with relapsing remitting multiple sclerosis. Fifty percent of the patients in the 5mg dose group experienced a reduction in new lesions as well as a reduction in total lesion load and volume as compared with 25 percent in the placebo group. Dosing in this trial was suspended in July following several reported cases of hypersensitivity. However, patients were followed for the full treatment period. The number of patients receiving the full treatment was too small to show statistical significance between the treatment and placebo groups. Based on these results, Nuerocrine is planning a new Phase IIb trial to establish the definitive efficacy profile and optimum dosing regimen. (See BioWorld Today, July 21, 1999, p. 1.)
¿ Proligo LLC, of Boulder, Colo., and Exiqon AS, of Vedbaek, Denmark, established a partnership for the commercialization of Exiqon's locked nucleic acids (LNA) technology. Proligo will have the right to manufacture and sell LNA oligonucleotides and monomers to third parties worldwide, while Exiqon will retain the right to develop and grant licenses for biochemical, diagnostic and therapeutic products containing LNA nucleic acid compositions. LNAs are novel nucleic acid analogs that can increase the performance of diagnostic assays that probe and evaluate genetic information and antisense and other genetic medicine approaches. Proligo is a joint venture between SKW Trostberg AG, of Trostberg, Germany and Gilead Sciences Inc., of Foster City, Calif.
¿ Shearwater Polymers Inc., of Huntsville, Ala., signed a license agreement with Sensus Drug Development Corp., of Austin, Texas, for the PEGylation of Sensus' somavert (pegvisomant for injection) human growth hormone receptor antagonist using Shearwater's proprietary technology. Shearwater will receive substantial up-front payments, rights to manufacture the PEG (polyethylene glycol) reagent and a share of downstream revenues.
¿ SkyePharma plc, of London, signed a development contract with Amgen Inc., of Thousand Oaks, Calif. SkyePharma will use its DepoFoam sustained-release injectable delivery system with an undisclosed Amgen product. Terms were not disclosed. Amgen will complete its evaluation of DepoFoam under the first phase of the agreement.
¿ Techniclone Corp., of Tustin, Calif., has committed to completing a licensing agreement for a segment of its vascular targeting agent (VTA) technology, specifically related to applications of photodynamic therapy agents (PDT) with Scotia Pharmaceuticals Ltd., of Sterling, UK. The deal's terms were not disclosed. Scotia has signed a binding letter of intent with Techniclone for the worldwide exclusive rights to this area. The VTA technology is a therapeutic platform designed to specifically target tumor vasculature and subsequently destroy the tumor with various attached therapeutic agents.
¿ The SNP Consortium Ltd., of Chicago, has issued a request for applications (RFA) to determine how frequently single nucleotide polymorphisms - minute genetic variations - occur in major populations. Respondents to the RFA may be from academia or industry. The RFA seeks information regarding SNP allele frequency (the proportion of a population that shows the variation in the genetic code) for at least 60,000 SNPs identified through the consortium's research.
¿ University of Washington researchers have produced a working draft of the rice plant genome, which may give scientists the potential to dramatically improve the production of rice. Rice is the largest genome and first plant to be mapped in a working draft form. Monsanto Co., of St. Louis, sponsored the research.
¿ V.I. Technologies Inc., of Watertown, Mass., started a Phase III trial for its next-generation PLAS+SD plasma transfusion product. The new product not only inactivates lipid-enveloped viruses including HIV, hepatitis C and hepatitis B, but also is depleted of the antibodies that cause plasma to be blood type specific.
¿ Atlantic Technology Ventures Inc., of New York, said it filed an investigational new drug application with the FDA seeking approval to begin clinical trials for CT-3 (ajulemic acid), a compound the company believes will have significant analgesic and anti-inflammatory properties without the traditional side effects associated with current nonsteroidal anti-inflammatory drugs. A Phase I clinical trial is expected to begin in May in France.
¿ PR Pharmaceuticals Inc., of Englewood, Colo., said it purchased 52.95 percent of the outstanding stock of Verex Laboratories Inc., of Fort Collins, Colo. The selling shareholders received one share of PR Pharmaceuticals for each 15 shares of Verex common stock. PR Pharmaceuticals has committed to make a tender offer to purchase the remaining shares of outstanding Verex stock on a similar exchange basis or for a cash purchase price.
¿ Sangui BioTech International Inc., of Santa Ana, Calif., said it issued an additional 8 million shares of common stock at 96.4 cents per share to its long-term financial partner, the Germany-based EuroAmerican Beteiligungsvermittlungsgesellschaft mbH. The company now will have 40.3 million shares outstanding. Net proceeds are expected to be about $7.5 million.