arGentis Acquires Rights to Rheumatoid Arthritis Therapy Entering Phase I Clinical Trial

First Clinical Trial of Orally-Administered Altered Peptide Ligand Therapeutic
MEMPHIS, Tenn.--(Business Wire)--
arGentis Pharmaceuticals, LLC today announced that it will collaborate with the
University of Tennessee Health Science Center (UTHSC) and the Veterans Affairs
Medical Center of Memphis (VAMC) to initiate the first human clinical evaluation
of an oral altered peptide ligand (APL), ARG301, in a Phase I study of
Rheumatoid Arthritis patients. ARG301 is a synthetic peptide, which in animal
studies appears to down regulate autoimmunity to Type II collagen (CII), a known
autoantigen in RA. Investigators at the UTHSC and Memphis VAMC developed the
therapy and have received a Clinical Merit Review Grant from the Department of
Veterans Affairs to conduct the trial.

"Due to its unique mechanism of action and compelling preclinical data, we are
hopeful that ARG301 will offer a novel therapeutic approach for rheumatoid
arthritis," said Tom I. Davis, II, Chief Executive Officer of arGentis. "In
continuing our partnership with UTHSC and University of Tennessee Research
Foundation, arGentis is very pleased to add this promising oral therapeutic
consistent with our autoimmunity R&D approach."

Research in animal models suggests APLs (Altered Peptide Ligands) are effective
in preventing and ameliorating tissue-specific autoimmune diseases. Trials of
APLs administered intravenously or subcutaneously in human autoimmune disease
have had mixed results. None of these trials, however, incorporated a
pre-selection step to test the ability in vitro of the APL, to down regulate Th1
response by patient`s peripheral blood mononuclear cells (PBMC) stimulated by a
disease-specific autoantigen such as CII in RA patients.

In preclinical testing, mice susceptible to Collagen Induced Arthritis (CIA)
bear a transgene for the human RA MHC susceptibility genes, DR1 or DR4. These
mice appear to be resistant to CIA after oral administration of ARG301. Although
the precise mechanism by which the specific peptide comprising ARG301 exerts its
effect is not yet clear, the interaction of the APL/MHC complex with the TCR
appears to play a key role in influencing the differentiation of naive T cells
into effector cells.

Based on the experience in animals, oral administration of APLs to preselected
"in vitro" responders should provide a nontoxic and highly defined therapy for
humans with tissue-specific autoimmune diseases such as RA.

42 RA patients will be enrolled a Phase I Trial at the Memphis VAMC which will
evaluate multiple ascending doses of ARG301 to be administered orally. The
primary objectives of the trial will be to determine if one or more of the three
doses of ARG301 given to Rheumatoid Arthritis patients will generate functional
T regulatory cells and decrease immune reactivity to CII. The study will have 3
ARG301 treatment arms, each with 10 patients and a placebo arm of 12 patients.
Patients will be enrolled who have demonstrated T cell immunity to CII and have
an in vitro response to ARG301 at the screening visit. Patients will be
randomized to one of the 4 arms, and each of the 3 ARG301 and placebo treatments
will be given for 16 weeks.

About ARG301

The altered peptide ligand ARG301 is an oligopeptide derived from human CII
sequence with substituted amino acids that binds to the MHC class II and
interacts with the T cell receptor. ARG301 acts to change the cytokine profile
from Th1 to Th2. Preclinically, DR1 or DR4 transgenic mice treated with oral or
parenterally administered ARG301 were protected from arthritis induced by CII
immunization. Short term toxicity studies using 100x the maximal human dose of
ARG301 on a weight basis in mice did not cause any detectable toxicity. ARG301
is anticipated to have an exceptionally good safety profile in the clinic. To
prove concept, ARG301 will eventually be evaluated in a broader trial of
Rheumatoid Arthritis patients.

About Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an autoimmune disease that causes chronic
inflammation of the joints and is the most common form of inflammatory
arthritis. RA most often affects the smaller joints, such as those of the hands
and/or feet, wrists, elbows, knees, and/or ankles. The cause of RA is not known
but usually develops between 30 and 50 years of age. Although there is no cure
for RA, the disease can be controlled in most people. Early, aggressive therapy
to stop or slow down inflammation in the joints can prevent or reduce symptoms,
joint destruction and deformity.

RA has a significant impact on both individual lives and society, including:

* According to the Centers for Disease Control and Prevention (CDC), arthritis
and other rheumatic conditions are the leading cause of disability in the U.S.,
* 3 million RA sufferers in the U.S.,
* 2.2 million are women,
* U.S. incidence expected to increase to 5.8 million in the U.S. by 2013,
* According to Johns Hopkins, disability is higher among patients with
rheumatoid arthritis, with 60 percent being unable to work 10 years after
disease onset,
* People with rheumatoid arthritis have an increased risk of mortality or death
rate compared to the general population, living 10-15 years less than healthy
counterparts.

About Veterans Affairs Medical Center

The Department of Veterans Affairs Medical Center is affiliated with the
University of Tennessee Health Science Center. Since 1922, the Memphis VAMC has
been improving the health of the men and women who have so proudly served our
nation with services available to more than 196,000 veterans living in a
53-county area of western Tennessee, northern Mississippi and northwest
Arkansas.

About arGentis Pharmaceuticals

arGentis Pharmaceuticals is a privately-held diversified biopharmaceutical
company dedicated to the licensing, development and commercialization of novel
classes of therapies to treat chronic diseases in autoimmunity and
ophthalmology. arGentis` drug R&D programs are focused on treating underlying
mechanisms of inflammatory conditions through utilization of oral and
transdermal compounds. With its experienced management team, world-class
scientists and advisors, arGentis is well-positioned to capitalize on its
extensive portfolio of more than 50 patents and applications.

arGentis Pharmaceuticals, LLC
Ted Townsend, 901-818-3262
Vice President, Business Development

Copyright Business Wire 2009