[Proneuron1] Proneuron/Cell Design press release

[marjie hadad]

For Release

 

 

 

Proneuron and Cell Design of Atlanta to 


Establish a New Cell Processing Facility in Atlanta to Support


The Current Phase II Trial of ProCord for Complete Spinal Cord Injury



Atlanta, GA. and Los Angeles, CA, June 7, 2004 ---  Proneuron
Biotechnologies, Inc and Cell Design, L.L.C. announced today that the
two companies have entered into an agreement to establish a new human
cell processing facility in Atlanta to support the current Phase II
study of Proneuron’s Procord, autologous incubated macrophages for
complete spinal cord injury.  Cell Design, a subsidiary of Cell
Dynamics, LLC, will provide the required cell processing facility for
the manufacturing of ProCord in the southeast region of the U.S. for
this international, multi-center, randomized-controlled clinical trial.
The agreement with Cell Design will support Proneuron's collaboration
with the Shepherd Center in Atlanta, which is anticipated to begin
enrollment in 2004 and is already taking an active role in the study.
Upon receipt of the requisite approval of the United States Food and
Drug Administration, the facility will also provide for the commercial
manufacturing of ProCord. 

 

"We are very enthusiastic about the relationship with Proneuron.
Proneuron's technology provides our company with an exciting foray into
the field of spinal cord research and autologous cell therapy. We very
much look forward to working with this fine international team on what
is clearly a very important study," said Dr. Robert McNally, President
of Cell Dynamics, LLC. 

 

Following tissue injury, a type of white blood cell, called a
macrophage, quickly starts to remove cell debris. These macrophages then
start to secrete growth factors that promote a controlled inflammatory
reaction to initiate the wound healing process. While this process
occurs effectively in most tissues including peripheral nerves, it does
not occur effectively in the central nervous system (CNS).  Discoveries
led by Prof. Michal Schwartz of the Weizmann Institute of Science have
shown in pre-clinical studies that specially treated macrophages promote
recovery from spinal cord injury (SCI). Based on these findings,
Proneuron is now evaluating the safety and efficacy of ProCord,
currently an experimental procedure for patients with complete spinal
cord injury.  Complete spinal cord injury is defined as having no
feeling or movement below the point of injury.

 

"Cell Dynamics has a strong track record in the processing of human
cells according to FDA regulations and current Good Manufacturing
Practices (cGMP).  We are therefore delighted that they have joined the
study.  The Cell Design subsidiary, together with our other existing
cell centers, one in Denver, CO and the other in Hackensack, NJ (in
collaboration with Progenitor Cell Therapy), will set the basis for
Proneuron’s next stage in the development and commercialization of
ProCord in the US," said Nir Nimrodi, Proneuron's Chief Executive
Officer.

 

  

About Proneuron Biotechnologies
Proneuron 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
proprietary technology for modulating the interaction between the
nervous and immune systems. The company's products are currently being
evaluated in several clinical studies located in the U.S., Belgium and
Israel. These include: an independently managed, international,
multi-center, randomized-controlled Phase II trial of ProCord,
autologous incubated macrophages, an experimental procedure for spinal
cord injuries and a Phase II program of Cop-1 for the treatment of
Glaucoma and other neurodegenerative diseases. The latter is being
managed by Teva as part of the Proneuron’s strategic collaboration for
development and commercialization of Cop-1 for various neurodegenerative
indications. The Company is also developing PN277 for the treatment of
additional neurological diseases.

 

About Cell Dynamics, L.L.C.
Cell Dynamics is an FDA inspected cGMP tissue processing laboratory
dedicated to the processing of human tissues and cells for research,
transplant and cell-derived therapeutics. The company currently
specializes in procuring and processing tissues from human cadaveric
donors. Active programs have been established for human kidneys, heart,
liver, cartilage and dermis, a unique source of progenitor and stem
cells.  Autologous blood and tissues will be processed for the treatment
of patients with spinal cord injuries.  For more information about Cell
Dynamics, visit  <http://www.celldynamicsllc.com/>
www.celldynamicsllc.com 

 

For additional information: Marjie Hadad, media liaison, Proneuron,
Marjie.hadad at proneuron.com
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