Phytomedics' Novel Oral Disease Modifying Drug Candidate PMI-001 Demonstrates Positive Phase II Results In Rheumatoid Arthritis

Phytomedics Inc., a
biopharmaceutical company merging human health care and plant biotechnology
to discover, develop and manufacture novel botanical therapeutics,
announced positive results of a six-month, multi-center, randomized,
double-blinded, active treatment-controlled phase II clinical trial of
PMI-001 in patients with either new onset or therapy-resistant rheumatoid
arthritis (RA), conducted under an investigator-held Investigational New
Drug (IND) application.



The trial compared PMI-001 as a stand-alone, disease-modifying,
anti-rheumatic drug (DMARD) to sulfasalazine (active treatment control) in
subjects with RA. This study was conducted at 11 sites in the U.S., with
the National Institutes of Health's (NIH) National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS) being the coordinating
center. Peter Lipsky, M.D. (IND-holder) chief, Autoimmunity Branch, NIAMS,
and Raphaela Goldbach-Mansky, M.D., staff clinician, NIAMS, were the
principal investigators. One hundred and twenty-one (121) subjects received
treatment. Of these, 60 were randomized to PMI-001 and 61 were randomized
to Sulfasalazine.



The primary efficacy endpoint in this study was the proportion of
PMI-001 subjects who achieved an ACR20 response at the end of the trial in
comparison to the proportion of sulfasalazine-treated subjects. At the end
of the trial, a significantly greater proportion (53.3%) of subjects in the
PMI-001 treatment group achieved an ACR20 response than in the
sulfasalazine group (21.3%). In addition, responder rates for the ACR50
(36.7% vs 3.3%), and ACR70 (26.7% vs 3.3%) were significantly higher for
subjects treated with PMI-001. Also, each of the ACR component variables
demonstrated a significant improvement at the final visit. All variables
except for the swollen-joint count also demonstrated significant
improvement at the Week 2 visit. HAQ disability score also showed
significant improvement 2 weeks after treatment with PMI-001 was started.
In the hand and foot x-rays, the post-treatment mean change in the
sub-scores for erosions / joint space narrowing and the total score for
subjects treated with PMI-001 all demonstrated a numerical decrease. These
scores increased in subjects treated with sulfasalazine. Both treatment
groups showed similar overall adverse events rates, which were mild in
nature.



"We are extremely pleased with the results of PMI-001 in this third
clinical study," said Bertold Fridlender, president and CEO of Phytomedics
Inc. "The magnitude of clinical activity observed with PMI-001 as a
stand-alone DMARD demonstrates the potential clinical utility of this new
drug candidate and further validates Phytomedics' novel drug development
approach."



"Additionally, the fact that with an oral drug candidate we are able to
reach such impressive stand-alone efficacy results so rapidly, with a mild
side effect profile and early evidence of disease modification activity,
speaks to the significant potential of PMI-001, not only in RA, but across
the entire autoimmune disease category," said Fridlender.
















About PMI-001



PMI-001 is a novel, orally bioavailable, small-molecule-based,
plant-derived, multi-component disease modifying agent currently being
developed for rheumatoid arthritis. PMI-001 exerts its potent
anti-inflammatory and immunosuppressant activities through unique and
synergistic modes of action, which involves potent inhibition of several
families of pro-inflammatory genes. Potential applications of this drug
candidate beyond rheumatoid arthritis include a wide range of autoimmune
disorders including psoriasis, lupus, inflammatory bowel disease (IBD), and
multiple sclerosis (MS).



About Phytomedics Inc.



Phytomedics Inc. (phytomedics) uses a broad and
innovative proprietary technology platform formulated by Professor Ilya
Raskin to discover, develop and manufacture novel, multi-component and
multi-functional botanical therapeutics. Through this proprietary
technology platform, the company has produced a broad pipeline of lead
product candidates, several of which are in clinical development. Founded
by Professor Ilya Raskin, Ph.D., presently the company's Chief Scientific
Officer, Phytomedics Inc. conducts most of its R&D at the Biotech Center of
Rutgers University.


Phytomedics Inc.

phytomedics