Amylin Pharmaceuticals Inc., of San Diego, initiated the first Phase II study of the AC2993 LAR development program. The goal of the program is the development of a once-a-month injection of Amylin's drug candidate AC2993, or synthetic exendin-4, as a treatment for Type II diabetes. The double-blind, placebo-controlled, multicenter study will focus on safety and tolerability, as well as the pharmacokinetic profiles of rising doses of two formulations of AC2993. The study also will examine effects of AC2993 LAR on fructosamine, HbA1c and fasting and post-meal glucose concentrations. AC2993 is a 39-amino-acid peptide.
Applied Genetics Inc. Dermatics, of Freeport, N.Y., said the National Cancer Institute intends to conduct a one-year clinical trial of Dimericine, the company's topical liposomal DNA repair enzyme, to reduce the rate of skin cancer in renal transplant patients. The proposed trial will test the lotion on patients with high rates of skin cancer.
Aradigm Corp., of Hayward, Calif., and researchers from the Jean Hailes Foundation in Melbourne, Australia, presented data on inhaled testosterone administered by the AERx system, a pulmonary drug delivery platform. Data showed that pulmonary delivery of testosterone in female patients with low levels of testosterone was safe, with rapid absorption. The open-label, single-dose escalation study enrolled 12 postmenopausal women on a regimen of oral estrogen for hormone replacement therapy. Testosterone was administered using the AERx system. The presentation was made at the 84th annual meeting of The Endocrine Society in San Francisco over the weekend.
AVI BioPharma Inc., of Portland, Ore., said the journal Drug Metabolism and Disposition will feature an article on an AVI study as the cover story in its July issue. The study demonstrated that AVI's Neugene antisense technology can inhibit a key metabolic enzyme in human liver cells, cytochrome P450, and was based on preclinical research conducted by AVI scientists. AVI particularly targeted CYP3A4, which is responsible for the metabolic breakdown of about 50 percent of current FDA-approved drugs.
BattellePharma Inc., of Columbus, Ohio, began work on a second new chemical entity with GlaxoSmithKline plc, of London, for treating asthma that will use BattellePharma's Mystic electrohydrodynamic technology. The terms of the second agreement were not disclosed.
Bavarian Nordic A/S, of Copenhagen, Denmark, said the subscription of shares in its rights issue closed. In total, 959,140 new shares were subscribed to at DKK70 per share, for gross proceeds of DKK67 million (US$8.8 million). The net of about DKK50 million is expected to finance operations until April 2004.
BioMarin Pharmaceutical Inc., of Novato, Calif., reported findings from the 24-week, open-label extension portion of the Phase I trial of Aryplase (recombinant human arylsulfatase B), an investigational enzyme replacement therapy for mucopolysaccharidosis VI. Data from the study showed that Aryplase continued to be well tolerated at both dose levels by the five patients who had received treatment for a total of 48 weeks. The 1.0 mg/kg dose continued to produce a greater sustained reduction than the 0.2 mg/kg dose in the excretion of urinary glycosaminoglycans over 48 weeks, which indicates that Aryplase is breaking down the complex carbohydrate materials that accumulate in patients with MPS VI.
Celgene Corp., of Warren, N.J., reported the initiation of five additional trials of Revimid in hematological and solid tumor cancers. The trials will evaluate the pharmacology, safety and efficacy of Revimid as a treatment for multiple myeloma and all types of solid tumor cancers. The orally available agent is the company's lead immunomodulatory drug. Celgene recently initiated two Phase II trials of Revimid in multiple myeloma.
Cellectis SA, of Paris, completed a second round of financing, raising 16 million (US$16.7 million). Investors included BankInvest BioMedical Venture, AGF Private Equity, funds managed by LCF Rothschild Asset Management, and Odyssee Venture. Cellectis has raised 20 million since its inception in December 1999. Cellectis applies its Meganuclease Recombination Systems approach to in vivo genome engineering.
CollaGenex Pharmaceuticals Inc., of Newtown, Pa., received the final marketing authorization for its lead product, Periostat (doxycycline 20 mg tablets), from the ministries of health in the Netherlands and Portugal. Periostat is an oral adjunctive therapy to scaling and root planing in the treatment of adult periodontitis, a condition that affects about 12 percent to 15 percent of the adult population in many countries. Periostat tablets were approved by the UK MCA in February 2001 and by the FDA in April 2001.
Cytyc Corp., of Boxborough, Mass., said the U.S. Federal Trade Commission voted to block Cytyc's proposed acquisition of Digene Corp., of Gaithersburg, Md. The five-member commission authorized FTC staff to seek a court order to halt the acquisition. Cytyc reported in February that it planned to acquire Digene in a deal valued at $554 million. (See BioWorld Today, Feb. 20, 2002.)
GlycoGenesys Inc., of Boston, said its lead drug candidate, GCS-100, being developed in a joint venture with Elan Corp. plc, of Dublin, Ireland, is spotlighted in the cover story of the July 2002 issue of Scientific American in an article titled "Sweet Medicines." The article reveals the critical roles sugars play in cellular functions and in disease. It describes how discoveries using glycobiology hold potential for new drug therapies in development such as GCS-100, while also providing improvements to existing drug therapies.
Introgen Therapeutics Inc., of Austin, Texas, presented its lead therapeutic, Advexin p53 gene therapy, at the 11th International p53 Workshop in Barcelona, Spain. Introgen presented information on Advexin from Phase I and Phase II trials showing the product selectively kills cancer cells in tumors. The product is in two randomized, controlled Phase III trials in patients with head and neck cancer. Advexin is designed to use the p53 gene to kill cancer cells and stop tumor growth.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a planned second Phase III trial of alicaforsen (ISIS 2302), an antisense inhibitor of intercellular adhesion molecule-1 (ICAM-1), in people with Crohn's disease. Isis plans to enroll 150 patients at 35 sites in Europe in a randomized, double-masked, placebo-controlled study. The primary endpoint is clinical remission as defined by a Crohn's disease activity index score of less than 150, with no increase in the use of medications or need for surgery. The endpoint is the same as the North American trial, initiated in November. (See BioWorld Today, Nov. 30, 2001.)
LION bioscience AG, of Heidelberg, Germany, said Pfizer Inc., of New York, purchased a worldwide license to LION's predictive ADME simulation software called iDEA. Pfizer purchased a license to the absorption module of iDEA, which includes an evaluation of iDEA's metabolism module. The software has been customized for high-throughput use at Pfizer's Ann Arbor, Mich., laboratories. Financial terms were not disclosed.
Milan P Enterprises LLC, of Costa Mesa, Calif., was formed by Milan Panic, the founder and former chairman of ICN Pharmaceuticals Inc., also of Costa Mesa. The company will focus on both business and humanitarian issues around the world. Panic, a former prime minister of Yugoslavia, remains a member of the ICN board and is among the largest individual shareholders in the company.
Nanogen Inc., of San Diego, and Bio-Rad Laboratories Inc., of Hercules, Calif., entered a worldwide, nonexclusive license agreement for the two most common gene mutations for the diagnosis of hereditary hemochromatosis. Bio-Rad granted Nanogen a license to the C282Y and H63D mutations of the HFE gene for use in Nanogen's NanoChip system. Financial terms were not disclosed.
Neurocrine Biosciences Inc., of San Diego, initiated the final pivotal Phase III trial of indiplon-IR, its immediate-release formulation, in patients with chronic insomnia patients. It now is conducting six of eight planned Phase III trials with indiplon-IR and indiplon-MR, its modified-release formulation, and expects to initiate the remaining two Phase III trials of indiplon-MR this year. The company expects to file a new drug application for both formulations at the end of 2003. The company initiated the first Phase III trial with its MR version earlier this month. Overall, the company will run five Phase III trials with indiplon-IR and three Phase III trials with indiplon-MR in a total of about 3,500 patients with both chronic and transient insomnia. (See BioWorld Today, June 5, 2002.)
Norak Biosciences Inc., of Research Triangle Park, N.C., signed a limited, nonexclusive license agreement with AstraZeneca plc, of London, to use its Transfluor technology for G protein-coupled receptor drug discovery. Norak will provide its Transfluor technology and knowledge related to GPCR targets to AstraZeneca for use in an internal GPCR drug discovery project. Financial terms were not disclosed.
Oxford BioMedica plc, of Oxford, UK, said its motor neuron disease product development program, a collaboration with the Centre for Functional and Restorative Neurosurgery, a part of The Cleveland Clinic Foundation in Ohio, received a grant of $120,000 from the USA Amyotrophic Lateral Sclerosis Association. BioMedica is assessing a series of five genes as components of a product to address the motor neuron disease market, of which Lou Gehrig's disease is the most common manifestation.
Viventia Biotech Inc., of Toronto, completed a private placement of three convertible secured debentures for gross proceeds of C$6 million (US$3.9 million). Each debenture carries a principal amount of C$2 million and all three were sold to units of the Dan family, which owns about 81.5 percent of Viventia Biotech. The investment will be sufficient to operate the company until the end of the year, the company said. Viventia develops therapeutics based on the human immune response to cancer.
YM Biosciences Inc., of Mississauga, Ontario, completed recruitment in its North American Phase II pilot study in metastatic hormone-refractory prostate cancer. The trial is evaluating the company's lead drug candidate, tesmilifene, in combination with mitoxantrone/prednisone. The company reported at the ASCO meeting in May that a 70 percent objective pain response rate was reported in 27 evaluable patients.
Zycos Inc., of Lexington, Mass., received a milestone payment from Aventis Pasteur, of Lyon, France, for discovering antigenic information under a research collaboration initiated in 1999. Zycos would receive additional milestones and royalties from Aventis Pasteur for any product eventually developed based on the company's discoveries and commercialized by Aventis Pasteur. Aventis Pasteur researchers are using the epitope information resulting from the collaboration to design and assess cancer vaccines that will turn on the patient's immune response.