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To: Bernie Bildman who wrote (107)	5/21/1998 10:09:00 PM
From: KAKALAK	Respond to of 4891

The following is a copy of the written presentation from today's ASM conference. Controlled Clinical Trial of Reticulose, a Peptide-Nucleic Acid with Immunomodulator Activity in Patients with HIV Infection We performed a double-blind, placebo controlled trial of Reticulose, a non-toxic, low cost peptide-nucleic acid that stimulates Th-1 activity, to evaluate its effectiveness in treating adults infected with HIV. 43 of these patients, none of whom had ever received anti-retroviral therapy, were randomly assigned to receive either placebo or Reticulose: dosage schedule was two 1ml sub-q injections per day for two weeks, followed by 1ml sub-q injection per day in alternate weeks for 60 days (30 days total treatment). At regular intervals, CD4 and CD8 cell counts, viral load by quantitative PCR p24 antigen and routine hematological and biochemical parameters were measured, and clinical status were assessed. We observed, at entry into the study, a mean CD4 cell count of 232/ul in the Reticulose group (21 patients) and 215/ul in the placebo group (22 patients). At the end of the 60 day treatment period, the mean CD4 cell counts were 317/ul and 201/ul in the Reticulose and placebo groups, respectively (p<0.001). 60 days after the cessation of treatment, the mean CD4 cell count was 354/ul in the Reticulose group and 235/ul in the control group. There was also a similarly significant increase in CD8 cell counts in the Reticulose treated group. Following the treatment period, the mean CD8 cell count rose from 722 to 847/ul in the Reticulose treated patients, but only from 661 to 671/ul in the placebo treated patients (p<0.001). Hemoglobin levels increased in 78% of the patients treated with Reticulose, but in only 50% of patients receiving placebo. Body weight increased in 71% of the patients receiving Reticulose, while 60% of the patients receiving placebo lost weight. In contrast to the placebo-treated patients, none of the Reticulose treated patients developed severe or life-threatening opportunistic infections. Viral RNA levels decreased by 0.5 logs in 4 Reticulose-treated patients, but in none of the controls. There were no toxic side effects observed in, or reported by patients receiving Reticulose. Our results indicate that, in HIV-infected patients, treatment with Reticulose alone produces an early and sustained rise in CD4 and CD8 cell counts, as well as improved clinical outcomes, including weight gain, fewer opportunistic infections and lower mortality. These findings, describing a new type of therapy with a non-toxic, low cost immunomodulator, have major implications for the treatment of the global patient population with HIV/AIDS. I layman's terms: Reticulose treated patients were far better off than their placebo controlled counterparts. Most interesting, however, is that even after the Reticulose therapy ended, the patients who received the drug continued to improve in terms of both CD4 and CD8. It was as though their own immune systems were jump started. I AM KAKALAK