Several companies have recently reported productdevelopment milestones. Here is a partial summary:
Arris' Asthma Drug Enters Phase I
-- Arris Pharmaceutical Corp.'s first product candidate, APC366, has entered Phase I trials for the treatment of asthma atSouthampton General Hospital in Southampton, England.
The drug is a small-molecule modulator of two specificinflammatory targets that are released by activated mast cells.The company has not revealed the target of APC 366. Mast cellsare central to the body's immune reaction to various allergensand play a role in many types of tissue inflammation. When anallergen activates the mast cells, they release their contents,which include certain cytokines and lipid mediators thatinteract with surrounding tissues and trigger events in theinflammatory cascade.
Arris (NASDAQ:ARRS) of South San Francisco, Calif., said itanticipates filing an investigational new drug (IND) applicationwith FDA this year and beginning Phase II trials in the U.S. andthe United Kingdom by the end of the year. The company isalso evaluating APC 366 for the treatment of allergic rhinitisand allergic conjunctivitis.
AutoImmune Begins Clinicals on AI-401
-- AutoImmune Inc. (NASDAQ:AIMM) of Lexington, Mass., hasbegun a Phase I study of its oral recombinant human insulinAI-401 for the prevention and treatment of Type I diabetes. InType I diabetes, the immune system attacks and destroysinsulin-producing islet cells in the pancreas. AI-401 consists ofan antigenic protein derived from the pancreas that works tostimulate a protective immune response to prevent the body'sdestruction of islet cells.
-- InSite Vision Inc. (NASDAQ:INSV) of Alameda, Calif.,announced last week that it has begun a Phase III trial ofBetaSite for treatment of chronic glaucoma. BetaSite is asustained-release eyedrop formulation of the beta-blockerlevobunolol designed to enhance ocular absorption anddiminish systemic absorption.
The study involves 645 patients with either ocularhypertension or open-angle glaucoma. It is being conducted at25 centers in the U.S.
Chemex Halts Injectable Cytarabine Development
-- Chemex Pharmaceuticals Inc. announced last Friday that itwill cease development of an injectable formulation ofCytarabine for genital warts. The company said that althoughsome activity was observed in a safety and efficacy study, "theefficacy was not sufficient to allow further development of thisformulation."
Chemex said the lack of efficacy of the injectable formulationmay be due to rapid metabolism of the drug. The companyplans to study novel formulations that would slow down thedrug's metabolism. Chemex licensed Cytarabine from theUpjohn Co. for all dermatological indications.
In other areas, Chemex (NASDAQ:CHMX) of Fort Lee, N.J., hasbegun a Phase II study of masoprocol for use as an anti-wrinkling agent. Masoprocol is the active ingredient in Actinex,a topical drug marketed for the treatment of actinic keratoses,which Chemex developed and sold to Block Drug. Under its jointventure with Block Drug, Chemex has also completed a Phase Iirritation study of CHX 108 for mild to moderate psoriasis andfiled an IND for EPC-K1 for treatment of mild to moderateatopic dermatitis.
Genta Completes Phase III Trial of Acne Drug
-- Genta Inc. has completed a Phase III study of its topical acnedrug G-101 in France. The company plans to file an applicationfor approval in France during the first quarter and begin aPhase III trial in the U.S. during the year.
G-101 is the erythromycin salt of acetylcysteinylsallcylate.Genta (NASDAQ:GNTA) of San Diego reported that of 577patients treated in the double-blind, placebo-controlled, 12-week trial, subjects receiving G-101 had a statisticallysignificant reduction in the number of nodules compared toplacebo (p=0.015). The drug was also superior to placebo (pless than 0.001) in reducing comedones, papules, pustules andtotal lesions. Genta said the unexpected finding of activityagainst nodular acne "could set G-101 apart from all othertopical acne products."
Agouron To Begin Phase Ib Study of Cancer Drug
-- Agouron Pharmaceuticals Inc. is about to begin a Phase Ibstudy of an intravenous formulation of its anti-cancer drug AG-337 in the U.S. The multiple-dose, five-day, continuous-infusion study is intended to confirm the optimal dose andschedule of administration established in Phase Ia and Ibstudies conducted in England.
AG-337 is an inhibitor of thymidylate synthase (TS), anenzyme that Agouron said must be active to sustain the rapidproliferation of cancer cells. The company hopes to launchPhase II studies in the U.S. and the United Kingdom thissummer to test the drug against four to six different tumortypes. Agouron (NASDAQ:AGPH) of La Jolla, Calif., has anotherTS inhibitor, AG-331, already in clinical trials in the U.S.
Pharmos Completes Phase III Trial
-- Pharmos Corp. has completed the first Phase III trial of itsophthalmic steroid Loteprednol for treatment of giant papillaryconjunctivitis. The trial included more than 200 of the 700-pluspatients Pharmos has enrolled in its Phase III clinical trialprogram since last June.
FDA has requested that four Phase III trials be submitted inthe company's new drug application (NDA). The company saidit expects its second giant papillary conjunctivitis trial and aseason allergic conjunctivitis trial to also be completed shortly.Pharmos (NASDAQ:PARS) of New York said it expects tocomplete analysis of these trials, as well as a trial in uveitis, inorder to submit an NDA this summer.
Aprogenex Reports Results
-- Aprogenex Inc.'s GenSite DNA probe to identify fetalhemoglobin mRNA in various cell types was shown to have asensitivity of 98.1 percent and a specificity of 97.9 percent, thecompany recently announced. Aprogenex (ASE:APG) of Houstonsaid the next phase of the clinical trial will further analyzeGenSite's fetal-cell separation procedures and test several otherGenSite DNA probes for identification and enumeration ofchromosomes. Abnormal numbers of certain chromosomes canresult in common genetic disorders.
-- Brenda Sandburg News Editor
(c) 1997 American Health Consultants. All rights reserved.