ISRAEL 
HIGH-TECH & INVESTMENT REPORT

from the May 2002 issue


Biotechnology Update


Proneuron Set for Clinical Trials
Proneuron Biotechnologies Inc, one of Israel's most promising biotech companies, announced that it has reached its targeted eight patients for its Phase 1 clinical trial of activated autologous macrophage therapy for acute complete spinal cord injury (SCI). Follow-up of each patient continues for one year. Proneuron's clinical trial of the macrophage therapy began in 2000, under an 'Investigational New Drug' (IND) authorization from the US FDA and the Israeli Ministry of Health. Patients from the US, Europe and Israel participated in the study following the referral of leading hospitals. Those patients who met eligibility criteria were transported by Proneuron to Israel for administration of the experimental cell therapy and follow-up at the Sheba Hospital in Israel, before returning to their homes for long-term follow-up.

Over the course of the trial, Proneuron has had enquiries from hundreds of prospective patients wishing to enroll in the study. Dr. Valentin Fulga, Proneuron's Senior VP of Development, noted the enormous effort that patients, their families and their referring physicians have made in helping to advance Proneuron's clinical investigation and hope to continue and help others in return for their support.

Dr. Lammertse expressed cautious optimism for the potential of this treatment noting that, "the Phase 1 results suggest a positive treatment effect, giving clinicians hope that a new era of intervention is at hand." Proneuron is planning the next clinical study. The use of activated macrophages for nerve regeneration is based on technology developed in the laboratory of Prof. Michal Schwartz, of the Weizmann Institute of Science in Israel and licensed to Proneuron. Prof. Schwartz and her team have made the initial discovery that activated macrophages induced neurological recovery in the damaged spined.


Reprinted from the Israel High-Tech & Investment Report May 2002

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