Exhibit 99.1
PharmaFrontiers Provides Update, Financial Results
THE WOODLANDS, Texas--(BUSINESS WIRE)--April 15, 2005--
PharmaFrontiers Corp. (OTCBB:PFTR), a company involved in the
development and commercialization of cell therapies, today provides an
update on its research programs and future plans. In addition, the
Company reports financial results for the 12 months ended December 31,
2004.
Research and Development
"We began our journey as a public company during May 2004 with the
completion of a reverse merger into a public shell, and strengthened
our pipeline of potential therapies for the treatment of several
debilitating diseases," said David B. McWilliams, president and chief
executive officer of PharmaFrontiers.
In November 2004, the Company acquired Opexa Pharmaceuticals,
which held the rights to Tovaxin(TM), a novel autologous therapeutic T
cell treatment for multiple sclerosis. Tovaxin(TM) has considerable
potential because it attacks the underlying cause of MS rather than
just addressing its symptoms. Rights to Tovaxin(TM) originally were
obtained under an exclusive, worldwide license from the Baylor College
of Medicine in Houston, Texas.
Tovaxin is currently being studied in two Phase I/II clinical
trials. Patients have been enrolled in the first trial, which is an
extension study of patients previously treated with a first-generation
formulation of the therapy. These patients showed clinical benefit in
an earlier T cell therapy study conducted at Baylor College of
Medicine and are now being examined to determine if they can be safely
and effectively re-treated with a second-generation T cell therapy.
The first cohort of ten patients have received two-doses of the new
formulation of Tovaxin. PharmaFrontiers anticipates that six-month
results evaluating safety, tolerability and efficacy will be available
in the third quarter of 2005.
The second Phase I/II clinical trial is a dose-escalating study
with Tovaxin. The study is designed to evaluate safety, tolerability
and efficacy in at least 9 but not more than 15 patients. Six patients
have completed the initial four-dose injection schedule; the first
group of three patients received a low-dosage level, the second group
of three patients received a mid-dosage level and a third group of
three is to receive a high-dosage level. One-year clinical results for
the low and mid dose groups are expected to be available by the third
quarter of 2005.
"We believe that Tovaxin has advantages over existing treatments
for multiple sclerosis, which afflicts 400,000 individuals in the U.S.
alone," continued Mr. McWilliams. "This is true 'designer medicine',
because we make use of an individual's own T cells to manufacture the
therapy. Tovaxin seems easier to tolerate, has the potential to place
the disease into remission, and possibly reverse the effects. We are
looking forward to submitting data from these trials to the U.S. Food
and Drug Administration by the end of 2005 to request approval to
begin a pivotal Phase IIb study."
PharmaFrontiers continues to advance its pre-clinical research in
stem cell technology for the treatment of heart failure and Type I
diabetes. Its technology, licensed through its relationship with
Argonne National Laboratories from the University of Chicago, permits
the creation of adult pluripotent stem cells from monocytes isolated
from patients' own blood.
"Our stem cell technology avoids the emotional issues connected
with embryonic stem cell research, while from a clinical perspective
our technology is inexpensive, it is easy to obtain, and it avoids the
rejection associated with transplants, " Mr. McWilliams went on to
say. "We hope to be able to initiate human tests of our cardiac and
diabetes stem cell therapy some time in 2006. We also recognize the
potential use of our technology platform in the treatment of a host of
additional diseases, including macular degeneration, stroke and
Parkinson's disease."
Financial results
The company reported no revenue for 12 months ended December 31,
2004. General and administrative expenses were $3.1 million,
reflecting the start-up of the company and hiring of key employees.
Research and development expenses for the year ended December 31, 2004
were $0.6 million for PharmaFrontiers. On a pro forma basis for the
combined companies, research and development expenses for the year
ended December 31, 2004 were $2.4 million, mainly reflecting the costs
of the Phase I/II clinical trials for Tovaxin and pre-clinical cardiac
and diabetes stem cell research. Net loss was $4.6 million in 2004, or
$0.73 cents per basic and diluted share. The company had cash of $0.9
million at December 31, 2004. Subsequent to the end of the year,
PharmaFrontiers completed the second tranche of a total $6.1 million
interim financing in the form of convertible notes, with $4.5 million
closing in February of 2005.
About PharmaFrontiers Corp.
PharmaFrontiers' strategy is to develop and commercialize cell
therapies to treat several major disease areas such as cardiac and
pancreatic conditions and Multiple Sclerosis. The company holds the
exclusive worldwide license from the University of Chicago through its
prime contractor relationship with Argonne National Laboratory for
patents relating to the use of adult pluripotent stem cells derived
from patients' own circulating blood. PharmaFrontiers also owns
patented and proprietary individualized cell therapies that are in FDA
Phase I/II human dose ranging clinical trials to evaluate their safety
and effectiveness in treating MS.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements about PharmaFrontiers' growth and future
operating results, discovery and development of products, strategic
alliances and intellectual property, as well as other matters that are
not historical facts or information. These forward-looking statements
are based on management's current assumptions and expectations and
involve risks, uncertainties and other important factors, specifically
including those relating to PharmaFrontiers' ability to obtain
additional funding, develop its stem cell technologies, achieve its
operational objectives, and obtain patent protection for its
discoveries, that may cause PharmaFrontiers' actual results to be
materially different from any future results expressed or implied by
such forward-looking statements. PharmaFrontiers undertakes no
obligation to update or revise any such forward-looking statements,
whether as a result of new information, future events or otherwise.
CONTACT: PharmaFrontiers Corp.
C. William Rouse, 281-775-0608
brouse@pharmafrontiers.net
or
Lippert/Heilshorn & Associates
Investor Relations Contacts:
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com