[Proneuron1] Proneuron's ProCord Receives FDA Orphan Drug Designation

Sun Sep 12 23:19:40 PDT 2004

Greetings. Hope all is well. Please find below a copy of today's
Proneuron news. Thought this might be of interest.

Best wishes, Marjie Hadad, Media Liaison, Proneuron

For Release

Proneuron’s ProCord Receives FDA Orphan Drug Designation

ProCord (autologous incubated macrophage therapy), an experimental
procedure

for complete spinal cord injury, is currently being tested in an
international,

multi-center, randomized-controlled  Phase II trial in the U.S. and
Israel

Los Angeles, California, September 13, 2004 ---Proneuron Biotechnologies
( <http://www.proneuron.com/> www.proneuron.com) announced today that
the FDA has granted an orphan drug designation to ProCord, autologous
incubated macrophage therapy, to improve the motor and sensory
neurological outcome in cases of acute spinal cord injury.  

An orphan drug status is granted by The FDA Office of Orphan Products
Development (OOPD) ( <http://www.fda.gov/orphan/oda.htm>
http://www.fda.gov/orphan/oda.htm) to promote the development of
products that demonstrate promise for the diagnosis and/or treatment of
rare diseases or conditions.    In order to qualify as an orphan drug, a
product must target conditions that affect less than 200,000 people a
year in the U.S. and that should offer substantially improved
therapeutic benefit as compared to current medical regimens. Orphan drug
designation provides for seven years of market exclusivity in the U.S.
to the first entity that obtains marketing approval in the designated
indication. Other benefits to the sponsor include tax credits for the
costs of clinical research, reduced filing fees and preferential
pre-filing regulatory guidance. 

In the U.S. alone, there are an estimated 11,000 new spinal cord
injuries per year.  Causes include motor vehicle accidents, acts of
violence, falls, sports and other occurrences. SCI trauma usually
results in paralysis and other significant morbidity factors are common,
including respiratory failure, and bladder and bowel dysfunction.

Proneuron is currently engaged in an international, multi-center,
randomized-controlled Phase II study of ProCord in the U.S. and Israel.
Patients are currently being enrolled at the following sites:  Craig
Hospital in Colorado, Kessler Institute for Rehabilitation with UMDNJ at
Newark, New Jersey, The Mount Sinai Medical Center in New York, the
Shepherd Center in Georgia and the Chaim Sheba Medical Center in Israel.

ProCord is a result of the research efforts of Professor Michal Schwartz
of the Weizmann Institute of Science, who first proposed that specially
treated macrophages (a certain type of white blood cell) could stimulate
a wound-healing immune reaction in an immune privileged area like the
central nervous system.  

“It is an important milestone that the product of this research has been
granted an orphan drug status by the FDA and we shall continue to
rigorously investigate its potential in the current Phase II study for
complete spinal cord injury,” said Proneuron CEO Mr. Nir Nimrodi.

The ProCord clinical trial is open to patients who meet eligibility
criteria, including but not limited to ASIA Grade A, C5-T11, within 14
days of injury.  This is a randomized-controlled clinical trial.
Patients found eligible for the study are randomly assigned to either a
treatment or control group, two treatment patients for every one control
patient. Control patients do not undergo the procedure.  All control and
treatment patients receive standard spinal cord injury rehabilitation
and follow-up testing for one year.  It is crucial that trial site
investigators are notified of a potential candidate within a few days of
their spinal cord injury in order to give ample time for the clinical
staff to confirm patient eligibility and complete enrollment within the
14-day window of the clinical trial.  

Patient, Immediate Family of Patient and/or Physician inquiries:

24 hour a day Patient Recruitment Center:

Email: clinical.trial at 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

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.

Press inquires: Marjie Hadad, Media Liaison, Proneuron,
<mailto:Marjie.hadad at proneuron.com> Marjie.hadad at proneuron.com;
+972-54-536-5220.

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