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Thread: Proneuron Biotechnologies Announces Initiation of Second Phase 1 Clinical Trial in Complete Spinal Cord Injury

  1. #1
    Senior Member Jeremy's Avatar
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    Proneuron Biotechnologies Announces Initiation of Second Phase 1 Clinical Trial in Complete Spinal Cord Injury

    Proneuron Biotechnologies Announces Initiation of Second Phase 1 Clinical Trial in Complete Spinal Cord Injury


    Story Filed: Monday, October 22, 2001 12:22 PM EST

    NESS-ZIONA, ISRAEL, OCTOBER 22, 2001 (CCN Newswire via COMTEX) -- New Clinical Site in Brussels, Belgium will Facilitate Enrollment of European Patients into Trial of Activated Macrophage Therapy

    Proneuron Biotechnologies, a privately held company, today announced the initiation of a second Phase 1 clinical trial of autologous activated macrophage therapy for patients with complete spinal cord injury. This trial will be conducted at the Erasme Hospital in Brussels, Belgium with the approval of the Hospital's Ethics Committee and after notification of the Belgian Ministry of Health, and is designed to assess the safety of autologous activated macrophage therapy. The new study is intended to complement and extend the observations in the Company's first Phase 1 trial, conducted in Israel under a US Food and Drug Administration Investigational New Drug Application with the approval of the Israel Ministry of Health.

    The first study is designed to study approximately eight complete spinal cord injury patients and follow their post-treatment course for one year or longer. "We are nearing completion of the enrollment phase of our first clinical trial. To date, we have been pleased by the safety of this therapy and encouraged by positive therapeutic outcomes," said Dr. Valentin Fulga, Senior Vice President of Development at Proneuron. "Although it is too early to make definitive statements, we have observed positive clinical outcomes in terms of sensory and motor improvement in patients who by definition have a very poor prognosis in recovery from their paralysis. The availability of a second clinical site in Brussels will make it easier to enroll patients throughout Europe and expand our Phase 1 patient population."

    The principal investigator of the clinical trial will be Prof. Jacques Brotchi, Chairman of the Department of Neurosurgery at the Erasme Hospital. According to Prof. Brotchi, "Patients with complete spinal cord injury have a poor chance of functional recovery. We are pleased to be able to participate in a clinical trial with an innovative cellular therapy that has shown promise in preclinical and early clinical studies." The new Belgian cell-processing center will operate in collaboration with the Unit of Cellular and Molecular Therapy (UTCM) headed by Prof. Michel Goldman.

    The use of autologous 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 study the role of immunity within the central nervous system in the development of neurological disorders. Her research has demonstrated significant recovery of neurological function in animal models of spinal cord injury by administering activated macrophages.

    Macrophages are white blood cells that play a beneficial role in wound healing and tissue regeneration throughout the body. However, within the brain and spinal cord, resident macrophage activity appears to be inhibited, severely restricting the capacity for spontaneous regeneration. The strategy employed by Proneuron is to overcome the restriction on nerve regeneration by collecting autologous (taken from the patient himself) macrophages directly from the blood, activating them in the laboratory and then implanting them in the site of the injury. If the positive results of extensive animal experiments can be repeated in humans, the use of this therapeutic approach would be of significant clinical value even if only partial recovery can be achieved.

    In the new Belgian study, adults with a complete spinal cord injury in a segment from C6 to T11, and who can be treated within three weeks of their injury, may be eligible if they meet specified inclusion criteria. Macrophages are harvested from the patient, activated in a special facility and implanted surgically by the neurosurgeon. Following this procedure, patients will be intensively followed with safety monitoring and periodic assessments of neurological, radiographic and electrophysiological parameters. If results of the initial studies support additional clinical testing, a Phase 2 study will be initiated.

    Proneuron Biotechnologies is a biopharmaceutical company developing therapeutic products for the treatment of acute and chronic diseases of the central nervous system based on proprietary technology for modulating the interaction between the nervous and the immune systems.

    CONTACT: Proneuron
    (Israel) 972-8-940-9550
    Valentin Fulga, M.D.
    Senior Vice President Development
    Copyright (C) 2001, Canadian Corporate News. All rights reserved.

    Here's a bit more ......

    Story Filed: Monday, October 22, 2001 11:07 AM EST

    NESS-ZIONA, Israel, Oct 22, 2001 (BW HealthWire) -- Proneuron Biotechnologies, a privately held company, today announced the initiation of a second Phase 1 clinical trial of autologous activated macrophage therapy for patients with complete spinal cord injury. This trial will be conducted at the Erasme Hospital in Brussels, Belgium with the approval of the Hospital's Ethics Committee and after notification of the Belgian Ministry of Health, and is designed to assess the safety of autologous activated macrophage therapy. The new study is intended to complement and extend the observations in the Company's first Phase 1 trial, conducted in Israel under a US Food and Drug Administration Investigational New Drug Application with the approval of the Israel Ministry of Health.

    The first study is designed to study approximately eight complete spinal cord injury patients and follow their post-treatment course for one year or longer. "We are nearing completion of the enrollment phase of our first clinical trial. To date, we have been pleased by the safety of this therapy and encouraged by positive therapeutic outcomes," said Dr. Valentin Fulga, Senior Vice President of Development at Proneuron. "Although it is too early to make definitive statements, we have observed positive clinical outcomes in terms of sensory and motor improvement in patients who by definition have a very poor prognosis in recovery from their paralysis. The availability of a second clinical site in Brussels will make it easier to enroll patients throughout Europe and expand our Phase 1 patient population."

    The principal investigator of the clinical trial will be Prof. Jacques Brotchi, Chairman of the Department of Neurosurgery at the Erasme Hospital. According to Prof. Brotchi, "Patients with complete spinal cord injury have a poor chance of functional recovery. We are pleased to be able to participate in a clinical trial with an innovative cellular therapy that has shown promise in preclinical and early clinical studies." The new Belgian cell-processing center will operate in collaboration with the Unit of Cellular and Molecular Therapy (UTCM) headed by Prof. Michel Goldman.

    The use of autologous 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 study the role of immunity within the central nervous system in the development of neurological disorders. Her research has demonstrated significant recovery of neurological function in animal models of spinal cord injury by administering activated macrophages.

    Macrophages are white blood cells that play a beneficial role in wound healing and tissue regeneration throughout the body. However, within the brain and spinal cord, resident macrophage activity appears to be inhibited, severely restricting the capacity for spontaneous regeneration. The strategy employed by Proneuron is to overcome the restriction on nerve regeneration by collecting autologous (taken from the patient himself) macrophages directly from the blood, activating them in the laboratory and then implanting them in the site of the injury. If the positive results of extensive animal experiments can be repeated in humans, the use of this therapeutic approach would be of significant clinical value even if only partial recovery can be achieved.

    In the new Belgian study, adults with a complete spinal cord injury in a segment from C6 to T11, and who can be treated within three weeks of their injury, may be eligible if they meet specified inclusion criteria. Macrophages are harvested from the patient, activated in a special facility and implanted surgically by the neurosurgeon. Following this procedure, patients will be intensively followed with safety monitoring and periodic assessments of neurological, radiographic and electrophysiological parameters. If results of the initial studies support additional clinical testing, a Phase 2 study will be initiated.

    Proneuron Biotechnologies is a biopharmaceutical company developing therapeutic products for the treatment of acute and chronic diseases of the central nervous system based on proprietary technology for modulating the interaction between the nervous and the immune systems.


    CONTACT: Proneuron
    (Israel) 972-8-940-9550
    Valentin Fulga, M.D.
    Senior Vice President Development

    [This message was edited by Jeremy on October 22, 2001 at 01:28 PM.]

  2. #2
    Senior Member DA's Avatar
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    a second phase I trial.
    how many more phase I trials are they planning. 999999999?

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    I'll bet they had to start a new phase I trial in Brussels because nobody wants to go to israel during a civil war. I remember reading that they had very few people from the U.S. and Europe going, so they just decided to move the trial somewhere a little more marketable.

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    ?

    body

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    DA, I think they are trying to FINISH their phase 1. The medics are too busy telling people they aren't going to recover to let them know they have an option with Proneuron. It seems really strange to me that no hospital has approached Proneuron from the U.S. and asked to be a center where the trial could take place.

    It also seems very strange to me that Melissa's physical therapy hasn't been aggressive. As of 1 year post injury, she hadn't started brace walking yet .... I started in braces at eight months...I'm a complete T5 injury (of course I was told that was impossible for me.) It seems like once a person is inside the U.S., the message begins that it's OK to remain in a wheelchair. It's NOT OK. There's nothing OK about it.

  6. #6
    DA,

    I think that it is a very smart move by Proneuron. The phase 1 trial that they were carrying out in Israel had a one year followup period. They have enrolled 8 patients, the planned number. They have two choices now. They can either stop all enrollment and wait until the followup phase is over or they can start another phase 1 trial at another site.

    Please note that one company's phase 1 is another company's phase 2. Because they have not completed the followup of the first trial, they cannot really start a phase 2 trial. Eight patients is sufficient to show safety but may not be enough to show efficacy. If Proneuron is able to show impressive improvements in 16 patients, they will be able to go to what is called a phase 2b trial which may count as a phase 3 trial if the next trial results hit the primary outcome measures.

    Wise.

  7. #7

    Eric

    If everything goes as planned, within the next year, Craig Hospital in Englewood, CO will be the first U.S. hospital to fully engage in the Proneuron macrophage trial.

    Keep your fingers crossed. This could be very good for chronic injuries as well as acutes.

    FYI - Melissa was brace / gait training in August at Craig.

  8. #8
    Senior Member DA's Avatar
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    dr young, what would be the difference in proneurons Phase I and Phase II or III trials?

    will they increase macrophages injection level?

    if not, why not have all 3 phase trials altogether.

  9. #9
    Senior Member Duran's Avatar
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    Don't think so ...

    Should the future clinical trials in SCI move ahead with a tempo like Proneuron is keeping we would be surely fixed not until 2010, even that only partially... Therefore, God save us against similar practices and non-aggressively therapy like is this.

    Joe

  10. #10
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    Originally posted by Wise Young:


    The phase 1 trial that they were carrying out in Israel had a one year followup period. They have enrolled 8 patients, the planned number. They have two choices now. They can either stop all enrollment and wait until the followup phase is over or they can start another phase 1 trial at another site.

    Wise.
    They are apparently still enrolling patients because tomorrow a 19 year old Dutch boy will be transferred to Israel.He was injured about one week ago and a boy (who knew about Proneuron from the newsletters I wrote for a lot of Dutch SCI people) attended him at the possibility to go to Israel and he decided to go.So hopefully they have enough people in Israel now and their trial will progress a little faster from now on.Because it's unbelievable that it took almost 1,5 year to enroll the fase 1 trial.

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