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Executive Summary

VIMRx PHASE I TESTING OF LIQUID ORAL HYPERICIN FOR AIDS UNDER WAY, President Richard Podell told a recent meeting of the New York Society of Security Analysts. "We have just developed a liquid oral dose form" of the hypericin-derived agent for HIV- positive people, Podell said, explaining that VIMRx believes that "we must go to an oral dose form to have a commercially viable product." In October, the Stamford, Conn.-based R&D company incorporated bioavailability testing of the liquid dosage form of VIMRxyn into an ongoing Phase I study being sponsored by the National Institute of Allergy & Infectious Diseases' AIDS Clinical Trials Group. That study began in autumn 1991 with an I.V. dosage form ("The Pink Sheet" Jan. 20, T&G-10). VIMRx is exploring the therapeutic potential of hypericin, which is an extract from plants of the hypericum (St. John's wort) family, under a licensing agreement with New York University and the Weizmann Institute in Israel. The company has all the rights for commercialization of viral and anti-retroviral applications of aromatic polycyclic diones resulting from its hypericin R&D. Podell anticipates a Phase I/II trial of the liquid oral form following the current Phase I trial. In the current trial, patients will be dosed once orally and then switched to the I.V. regimen or vice versa. A solid dosage form of the plant extract is being developed by the University of Iowa under a joint NIH/VIMRx program. The ACTG study of the potential anti-retroviral hypericin began using a twice-weekly dosage of a maximum tolerated I.V. dose of .25 mg/kg in eight patients for eight weeks, with some patients remaining on the dosage regimen for up to 24 weeks. Four patients are now enrolled in an eight-patient, eight-week, three-times-a- week group. One person is being given I.V. dosing and one has been dosed once orally and is now being switched to the I.V. dose. VIMRx has just begun clinical trials of hypericin as a treatment for human papilloma virus, Podell told the analyst group. The company expects the Phase I trial to be completed by second quarter 1993. The 10-patient HPV trial is sponsored by VIMRx and is being conducted at Beth Israel Hospital, Boston. Recruitment of patients began in late October. The trial was prompted by "anecdotal evidence" from the AIDS hypericin trial: one patient began the trial with anal warts caused by HPV and "the warts went into total remission...after a short period of dosing" with hypericin, Podell told the NYSSA audience. VIMRx plans to study hypericin for use against cytomegalovirus retinitis (CMV) as well. "We hope that before the end of the year we have reached [a collaborative research and development] agreement so that we can start a trial against cytomegalovirus early next year," Podell said. The company also hopes to reach a joint agreement by the end of the year for the development of hypericin for use in blood banks to help assure that HIV-infected blood is not transfused into healthy patients. VIMRx expects to enter 1993 with about $3.5 mil. to $4 mil. in cash, which Podell estimates is enough to support the firm's activities through 1993. In addition VIMRx has warrants, expiring in July 1995, "which could generate up to $30 mil. of additional cash if exercised during 1993 or thereafter," he told the analysts. VIMRx went public in July 1990, netting about $4.5 mil. in proceeds. A secondary offering in 1992 yielded $5.7 mil.

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