Proneuron Completes Patient Recruitment for Its Phase 1 Clinical Trial for Complete Spinal Cord Injury; Patient Enrollment Continues for Additional Clinical Trial


Story Filed: Wednesday, April 10, 2002 8:00 AM EST

LOS ANGELES & NESS ZIONA, Israel, Apr 10, 2002 (BW HealthWire) -- Proneuron Biotechnologies Inc, today 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 a hope to continue and help others in return for their support.

Dr. Daniel Lammertse, Medical Director of Craig Hospital in Colorado and President of American Spinal Injury Association, has followed the clinical progress of several of the Phase 1 trial subjects. 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."

"So far there have been no serious adverse effects directly associated with the macrophage treatment. Furthermore, encouraging initial signs of some promising functional recovery have been observed in several patients. We are not aware of any other therapy with similar promising results," said Dr. Nachshon Knoller, Head of the Spine Unit at the Sheba Medical Center and principal co-investigator with Prof. M. Hadani.

Proneuron is planning the next clinical study, which will be conducted at centers in the US, Europe and Israel. Meanwhile, Proneuron has opened a phase 1b trial in Belgium, with the approval of the Belgian authorities, for which it continues to recruit patients with complete SCI. Prof. Jacques Brotchi, Head of the Neurosurgery Service at the Erasme Hospital in Brussels, is the principal investigator.

The use of activated macrophages for nerve regeneration is based on technology developed in the laboratory of Prof. Michal Schwartz, Weizmann Institute of Science, Israel and licensed to Proneuron. Prof. Schwartz and her team have made the initial discovery that activated macrophages induced neurological recovery in the damaged spinal cord of laboratory rats was the research basis for the development of the human clinical program.

Details of the eligibility requirements and contact information can be found at www.proneuron.com. About Proneuron
Proneuron Biotechnologies, a Delaware company, is a privately held biopharmaceutical company developing products for treatment of spinal cord injuries and other acute and chronic disorders of the central nervous system based on proprietary technology for modulating the interaction between the nervous and immune systems. For more information visit www.proneuron.com


CONTACT: Proneuron
Valentin Fulga, M.D., +972-8-940-9550
valentin@proneuron.com

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