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PASSIVE HYPERIMMUNE THERAPY (PHT) AIDS TREATMENT PROLONGS SURVIVAL AND PROTECTS IMMUNE SYSTEM IN CALIFORNIA CLINICAL TRIAL

PASSIVE HYPERIMMUNE THERAPY (PHT) AIDS TREATMENT PROLONGS SURVIVAL AND
 PROTECTS IMMUNE SYSTEM IN CALIFORNIA CLINICAL TRIAL
 MONTREAL, Oct. 26 /PRNewswire/ -- MEDICORP INC. announced today that its licensee, HemaCare Corporation of Sherman Oaks, Calif. reported promising 12-month results from its double-blind, placebo-controlled, clinical trial of Passive Hyperimmune Therapy, (PHT), a promising treatment for AIDS. Joshua Levy, M.D., senior vice president and medical director of HemaCare and the principal investigator of the study, presented the data in San Francisco to the fifth National Aids Update Conference.
 The results of the 12-month study confirm the previously reported 6-month, interim analysis. PHT improves survival, preserves T4 lymphocyte levels and maintains immune competence in those patients who begin treatment with circulating blood T4 cell levels of at least 50/mm3. No clinical benefit was observed for those patients who had T4 cell levels below 50/mm3 at entry into the study. (T4 cells are lymphocytes that are attacked and destroyed by HIV, the AIDS virus, with a resultant loss of immunity. The normal T4 cell range is 800-1200/mm3. AIDS symptoms usually appear at approximately 200/mm3, and patients with T4 levels less than 50/mm3 usually suffer from multiple opportunistic infections and may be too ill to benefit from most anti-HIV therapies, including PHT.)
 MEDICORP Has the world-wide exclusive license to commercialize PHT, developed by Dr. Abraham Karpas of Cambridge University. This US- patented technology covers the use of any neutralizing antibodies to treat AIDS. In its current format, PHT involves the collection of human plasma, rich in neutralizing antibodies against HIV, from healthy, HIV positive donors. The plasma is sterilized, pooled and infused into patients with symptomatic AIDS who display impaired immunocompetence and lack neutralizing antibodies.
 The study was conducted at three sites in southern California and three in northern California under the auspices of Hemacare and an oversight committee consisting of four scientists from the UCLA School of Medicine. A total of 219 patients with AIDS or ARC were enrolled and randomized into three groups receiving: 1) full strength hyperimmune plasma, 2)half-strength hyperimmune plasma, and 3) albumin as a placebo. All patients in the study also received standard anti-viral therapy of either AZT, DDI, DDC, or combinations thereof, throughout the trial and standard available prophylaxis for opportunistic infections. All remaining patients in groups 2 and 3 who participated for 12 months have been crossed over to full-strength PHT.
 The results demonstrate a dose-related improvement in survival and preservation of T4 cells in the group treated with PHT:
 12 Month Clinical Trial Results for Patients
 Beginning Treatment with T4 Cell Levels Between 50-200/mm3
 Full-Strength Half-Strength
 Hyperimmune Hyperimmune Placebo
 Plasma Plasma (Albumin)
 Number of Patients 20 18 24
 Mortality 1 death 3 deaths 5 deaths
 (5 pct) (17 pct) (21 pct)
 Decrease in T4 Cell Level 2 pct 25 pct 35 pct
 Patients receiving full-strength PHT showed favorable clinical and laboratory results as opposed to patients receiving half-strength or placebo. The data indicate that for AIDS patients having baseline T4 cells above 50/mm3, PHT: 1) improves the likelihood of survival, and 2) reduces the chance of suffering a first opportunistic infection. Laboratory data revealed that patients receiving full-strength PHT: 1) cleared HIV from the circulation as measured by p24 antigen in the blood and 2) generally maintained the level of T4 cells in the blood, a key indicator of immune system health.
 The treatment appears to be safe for patients as well as for the donors whose HIV-antibody plasma is used for the treatment. Not a single patient dropped out of the study due to toxicity from over 2,200 infusions involving 219 patients. Over 3,000 plasma donations were collected from 275 donors. No clinical adverse effect due to donation was observed. Most donors had no change or an increase in T4 cell counts and most had no change or an increase in p24 antibody titers during the time that they made multiple donations. This is an indication of a lack of detrimental effects to the donors.
 Dr. Elliott Block, president of MEDICORP, said, "These results of the largest clinical study of PHT to date are very encouraging and confirm previous studies in London and Paris. MEDICORP is looking forward to the expansion of these studies to more patients in a treatment IND. Also, we are particularly pleased that the NIH is planning to initiate shortly a study of the effectiveness of PHT in preventing maternal-fetal transmission of HIV. The continued promising results reinforces MEDICORP's belief in the viability of PHT as an important treatment for AIDS."
 MEDICORP is a biomedical company headquartered in Montreal with activities in AIDS therapeutics and diagnostics, molecular biology, cancer diagnostics, transplantation antigens, neuroscience and novel uses of monoclonal antibodies.
 -0- 10/26/92
 /CONTACT: Elliott Block, Ph.D., president of MEDICORP, 514-733-3000/ CO: MEDICORP INC.; HemaCare Corporation ST: California IN: MTC SU:


TM -- NE026 -- 4967 10/26/92 15:28 EST
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Date:Oct 26, 1992
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