Proneuron Phase II study

[MikeB]

October 8, 2003 09:00 AM US Eastern Timezone

Proneuron Biotechnologies Primes for U.S. Segment of IND Phase II study
of ProCord for the Treatment of Acute Spinal Cord Injury
Principal Investigators Meeting Held at the Kessler Institute for Rehabilitation in N.J.



Los Angeles, CA and West Orange, NJ, October 8, 2003 --- Proneuron Biotechnologies (www.proneuron.com), a leader in the development of medical treatments for spinal cord injuries and other disorders of the central nervous system, announced today the completion of its three-day investigator's meeting of its IND Phase II study of macrophage therapy (ProCord) for the treatment of acute complete spinal cord injury. The principal investigators along with key participants from the clinical centers met at Kessler Institute for Rehabilitation in West Orange, NJ for instruction on the implementation of the clinical protocol and training of the clinical specialists who will assess the study endpoints.



As of now, the treatment is provided at Sheba Medical Center in Israel, the first of five locations to host this study. Craig Hospital in Denver, Colorado, Principal Investigator, Dr. Daniel P. Lammertse is soon to enroll patients. Following the necessary approvals, Mount Sinai Hospital in NYC, Principal Investigator, Dr. Kristjan Ragnarsson; Shepherd Center in Atlanta, GA, Principal Investigator, Dr. David Apple and, Kessler Institute for Rehabilitation in West Orange, NJ, Principal Investigator, Dr. Steven Kirshblum, will also be enrolling patients.

"By bringing together the medical science, the technology and the clinical insight of researchers and physicians, the ProCord project offers great potential in advancing the care and treatment of individuals with acute spinal cord injury," noted Dr. Steven Kirshblum, Associate Medical Director/Director of Spinal Cord Injury Services, Kessler Institute for Rehabilitation. "It was an honor for Kessler to host this important meeting of the Phase II investigators and we look forward to collaborating with our colleagues across the country and around the world on this exciting project."



The meeting sessions included a review of the scientific rationale and proof of concept pharmacology studies, Phase I safety and efficacy results, the Phase II protocol, the role and responsibilities of the Independent Data Monitoring Committee and the 24-hour call center and patient recruitment flow.



"The Principal Investigator's meeting was productive and informative. All involved are now well versed and ready for the next steps. It is our hope that ProCord will continue to produce promising results and in turn begin to fill an unmet clinical need. In the meantime, I would like to emphasize that investigators must be notified of a patient within a few days of the injury and that ProCord must be administered within 14 days of the injury," said Dr. David Snyder, V.P. Clinical Development at Proneuron.



About Proneuron Biotechnologies

Proneuron Biotechnologies, Inc. is a privately held biopharmaceutical company developing products for the medical treatment of spinal cord injuries and other disorders of the central nervous system. Its products are based on a proprietary technology for modulating the interaction between the nervous and the immune systems. The company is currently engaged in several clinical studies in the U.S., Belgium and Israel. These include: a trial of Macrophage therapy (ProCord) for the treatment of spinal cord injuries and a trial of Cop-1 for the treatment of Huntington's disease (HD). In 2001, Proneuron entered into a strategic collaboration with Teva to develop and commercialize Cop-1 for various indications other than HD and ALS, indications that are being independently developed by Proneuron. Proneuron is also developing PN277 for the treatment of additional neurodegenerative diseases.




Patient, Immediate Family of Patient and/or Physician inquiries: 24 hour a day Patient Recruitment Center:

Email: clinical.trial@proneuron.com
Telephone: 1 866 539 0767 (U.S. toll free) or 1 506 652 3486.
Fax: 1 866-214-7078

*Callers outside of the U.S., please use standard international dialing code

[Chris Chappell]

I would suspect late November for the first patients - at least at Craig.

[Wise Young]

CORD TREATMENT TRIALS
Israelis who suffer spinal cord injury will be given treatment within 14 days of the accident as part of phase II clinical trials at Sheba Medical Center at Tel Hashomer. The study will include 61 patients between the ages of 16 and 65, all with complete spinal cord injury (SCI).

Proneuron Biotechnologies, a leader in the development of treatments for such injuries and other disorders of the central nervous system, has announced testing of ProCord. This treatment, developed by Prof. Michal Schwartz of the Weizmann Institute of Science, is described as autologous activated macrophage therapy for the treatment of patients with acute SCI. Macrophages isolated from the patient's own blood are activated through a proprietary process and then injected directly into the injured spinal cord.

Following tissue injury, a type of white blood cell called a macrophage is quickly mobilized and starts to remove cell debris. Macrophages then begin to secrete growth factors that promote a controlled inflammatory reaction - the initial phase of the wound-healing process. While this process normally occurs in most tissues, including peripheral nerves, it does not occur in the central nervous system, including the spinal cord. Schwartz has shown that specially treated macrophages promote recovery from SCI. Based on these findings, Proneuron is developing ProCord as a clinical product to treat spinal cord injured patients.

Schwartz's work has greatly interested Christopher Reeve, the "Superman" actor who became a quadriplegic when a horse threw him eight years ago, even though he is not suitable for the treatment.

Sheba is the first of five locations to host the study; others that have already received US Food and Drug Administration approval are Craig Hospital in Denver, Mount Sinai Hospital in New York and the Kessler Institute for Rehabilitation in West Orange, New Jersey.

Phase I studies in Israel and Belgium showed positive results in an encouraging number of patients; from complete loss of feeling and movement to recovery of some feeling and movement below the level of injury.

"We hope that this trial will lead to additional positive results that will ultimately enable us to offer a valuable treatment," said Dr. Nachshon Knoller, principal investigator at Sheba. In the US alone, there are an estimated 11,000 new spinal cord injuries per year. Causes include car accidents, acts of violence and falls.

[Isildur]

its for chronic or acute injuries?

[SCI-Nurse]

This therapy must be initiated within 15 days post injury, so is only appropriate at this time for new injuries.

(KLD)

[Max]

Thank you Mike,


Its good news for some lucky acutes.

Thanks Wise for making it sticky-so it may help some to get their lucky chance by reading it here. As you know-I tried to convince long ago to make it sticky

KLD,

Those are well known facts & printed in conditions of trials

[SCI-Nurse]

Max, you are loosing it. Dr. Young did not make this sticky. I did as soon as we converted to the new forums. Just like you to shoot off your mouth without knowing what you are talking about.

(KLD)

[Max]

Originally Posted by SCI-Nurse

Max, you are loosing it. Dr. Young did not make this sticky. I did as soon as we converted to the new forums. Just like you to shoot off your mouth without knowing what you are talking about.

(KLD)

Oh thank you not for trying to insultlol but for making it sticky fast in new forum-In old forum it took you 9 month to do so . For that I'm gratefull enternally to cheesecake to raise it up at that time. Hope she was not reprimanded for her initiative.

So I know exactly what I'm talking about

Overall its great info for new-sci & I'll be grateful to God, Wise, you etc if somebody will use this & may avoid total paralysis......

[SteveK]

Originally Posted by SCI-Nurse

This therapy must be initiated within 15 days post injury, so is only appropriate at this time for new injuries.

(KLD)

Actually it must be initiated within 14 days, with optimal results if the treatment is done on day 8 or 9.

[kj24skedoo]

I believe another criteria for the trial is the location of the damaged area can't be longer than 5mm.