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ISIS ANNOUNCES INITIATION OF CLINICAL TRIALS FOR ANTISENSE DRUG TO TREAT CMV INFECTIONS THAT CAUSE BLINDNESS IN AIDS PATIENTS

 CARLSBAD, Calif., Dec. 13 /PRNewswire/ -- Isis Pharmaceuticals Inc. (NASDAQ: ISIP) today announced that it has begun clinical trials for its antisense compound to treat cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is an opportunistic viral infection that affects AIDS patients and, in many cases, causes blindness. The drug, ISIS 2922, is the second antisense drug which Isis now has in clinical trials.
 Isis will initially first conduct a small Phase I study to examine the safety of ocular injection of ISIS 2922. This and a subsequent trial will focus on patients who have failed current therapies and have a CMV retinitis that is progressing. In later studies, Isis may test ISIS 2922 in combination with existing therapies and as a first-line therapy. ISIS 2922 should require less frequent dosing than existing therapies.
 CMV retinitis occurs in as many as 46 percent of patients with AIDS, and the incidence of CMV retinitis is increasing. Current therapies for CMV retinitis delay the progression of the infection for a short time, but eventually the disease advances. Patients frequently must cease taking current CMV drugs due to side effects or incompatibility with drugs being used to treat the HIV infection.
 ISIS 2922 is an antisense drug that prevents the production of a protein necessary for the virus to replicate. This highly selective and novel mechanism may result in fewer side effects than other drugs for this debilitating disease. In in vitro studies, Isis scientists have demonstrated that ISIS 2922 is active against strains of the virus that are resistant to current drug therapies. Isis believes that ISIS 2922 should be compatible with current CMV therapies and may be able to be given to patients who are receiving anti-HIV therapies. Studies in monkeys suggest that the drug can be safely administered by intravitreal injection on a weekly or biweekly schedule.
 "We are pleased with the FDA's response to our IND application and sincerely hope that ISIS 2922 will make a significant contribution to the treatment of this unfortunate disease," said Daniel L. Kisner, M.D., chief operating officer.
 Isis is co-developing ISIS 2922 in the United States and Europe with Eisai Co. Ltd. Eisai is a major Japanese pharmaceutical company which is globalizing its operations under the direction of Haruo Naito, president and chief executive officer.
 Inquiries having to do with ISIS 2922 should be directed to Isis' CMV information response line, 619-929-3898. (Editors: Okay to publish number.) Callers are asked to leave messages, and their questions and inquiries will be responded to promptly.
 Isis Pharmaceuticals Inc., based in northern San Diego County, is engaged in the discovery and development of novel oligonucleotide-based compounds. Isis has a broad oligonucleotide research program and has multiple compounds in preclinical development. ISIS 2105, the company's first oligonucleotide-based drug for genital warts, is in Phase II clinical trials.
 -0- 12/13/93
 /CONTACT: Lorraine Ruff of Stoorza, Ziegaus & Metzger, 619-236-1332 or 619-755-5610 (home)/
 (ISIP)


CO: Isis Pharmaceuticals Inc. ST: California IN: MTC SU:

JL-LS -- SD003 -- 2985 12/13/93 08:01 EST
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Publication:PR Newswire
Date:Dec 13, 1993
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