ACCESS NEWS
Contact: Company Contact: Investor Relations
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Kerry P. Gray Steve Laird
President & CEO Genesis Select
(214) 905-5100 (203) 341-0214
Donald C. Weinberger
Wolfe Axelrod
(212) 370-4500
ACCESS PHARMACEUTICALS, INC. ANNOUNCES
PRESENTATION OF AP5346 POLYMER PLATINATE
PHASE I CLINICAL TRIAL RESULTS
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-Study Shows Drug Has Favorable Toxicity Profile and Displays Efficacy -
DALLAS, TEXAS, October 1, 2004, ACCESS PHARMACEUTICALS,
INC. (AMEX: AKC) announced today that the results from
the Phase I clinical trial of AP5346 a DACH Platinum
Polymer Therapeutic were presented on Friday, October
1, 2004 at the 16th EORTC-NCI-AACR Symposium in Geneva,
Switzerland as a poster presentation.
The study was designed to identify the maximum
tolerated dose, dose limiting toxicities, the
pharmacokinetics of the platinum in plasma and the
possible antitumor activity of AP5346. The open-label,
non-randomized, dose-escalation Phase I study was
performed at two European centers. AP5346 was
administered as an intravenous infusion over one hour,
once a week on days 1, 8 and 15 of each 28-day cycle to
patients with solid progressive tumors. The
presentation reports on results in 19 patients with a
broad cross-section of tumor types, with doses ranging
from 80-1,280 mg Pt/m2.
Of the 19 patients, 7 were not evaluable for tumor
response, principally due to withdrawal from the study
prior to completing the required cycle. Of the 12
evaluable patients, 2 exhibited a response, 1 of whom
demonstrated a partial response and 1 of whom
experienced stable disease. The patient responding was
a
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Access Pharmaceuticals, Inc.
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melanoma patient with a lung metastasis, which a CT
scan revealed a tumor decrease of greater than 50%.
Also of note, a patient with cisplatin resistant
cervical cancer showed a short lasting significant
reduction in lung metastasis after 3 doses. However,
due to toxicity, the patient could not be retreated to
determine whether the partial response could be
maintained.
David P. Nowotink, Ph.D., Senior Vice President
Research and Development at Access who presented the
poster in Geneva stated, "In Phase I oncology studies,
patients treated are generally end-stage, having failed
numerous treatments including, in most cases, platinum
therapy. We are, therefore, very encouraged that we saw
evidence of efficacy of AP5346 in this study, as it is
not unusual that promising drugs may not display any
signs of efficacy in this type of patient population."
The dose limiting toxicity was established as
neutropenia. Other dose related toxicities included
nausea, vomiting, asthenia, fatigue and diarrhea. Renal
toxicity, electrolyte imbalances and anemia were also
observed which occurred principally at the highest
doses administered.
Dr. Nowotnik continued, "The toxicities associated with
AP5346 are those expected of a platinum agent and are
manageable in cancer therapy. One important finding was
that an expected toxicity was not seen. The active
agent of AP5346 is a DACH Platinum, which is also the
active agent of oxaliplatin, for which an acute
neurotoxicity, peripheral neuropathy, is the most
frequently observed dose-limiting toxicity. There was
no evidence of any acute neurotoxicity associated with
AP5346 during the Phase I study. This finding is
consistent with our preclinical data. It has recently
been reported in the scientific literature that the
acute neurotoxicity associated with oxaliplatin
probably results from oxalic acid, which is released
from oxaliplatin in the body. AP5346 is formulated
without oxalic acid which may account for this
favorable toxicity profile."
AP5346 was developed based on the principles of
polymeric drug delivery in order to improve the
therapeutic index (greater activity and less toxicity)
of platinum agents. As growing tumors establish their
blood supply, they develop vasculature which is
permeable to circulating large molecules such as
AP5346. Also tumors often have poor drainage systems
that allow for these large molecules to be trapped and
concentrated in tumors. AP5346 was also designed to
remain inactive in the plasma, and to become activated
only after entering the tumor cell. The results of the
Phase I study suggest that only a small fraction of the
platinum is released from the polymer in plasma,
indicating that this design goal was met.
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Access Pharmaceuticals, Inc.
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Recently, additional preclinical studies of AP5346 have
been completed which further add to the strong
preclinical package which has been developed for
AP5346. In a platinum resistant animal tumor model,
AP5346 was significantly more effective than
oxaliplatin.
Dr. Nowotnik continued "Demonstrating superiority in a
platinum resistant animal tumor model is yet another
piece of supportive data which adds to our excitement
for the potential of AP5346 in the treatment of
numerous cancers."
Access Pharmaceuticals, Inc. is an emerging
pharmaceutical company focused on developing both novel
low development risk product candidates and
technologies with longer-term major product
opportunities. Access markets Aphthasol(R) and is
developing products for mucositis and other oral
indications. Access is also developing unique polymer
platinates for use in the treatment of cancer and has
an extensive portfolio of advanced drug delivery
technologies including vitamin mediated targeted
delivery, oral delivery, and nanoparticle aggregates.
This press release contains certain statements that are
forward-looking within the meaning of Section 27a of
the Securities Act of 1933, as amended, and that
involve risks and uncertainties, including but not
limited to statements made relating to the results of
our polymer platinate program, the results of
preclinical and clinical studies for our polymer
platinate products, indications of efficacy of AP5346
in patients in a clinical study, the resumption of
supply of Aphthasol(R), projected milestone payments,
the OraDisc(TM) program and our ability to achieve
milestones. These statements are subject to numerous
risks, including but not limited to the uncertainties
associated with research and development activities,
clinical trials, our ability to raise capital, the
timing of and our ability to achieve regulatory
approvals, dependence on others to market our licensed
products, collaborations, future cash flow, the timing
and receipt of licensing and milestone revenues,
projected future revenue growth and our ability to
generate near term revenues, the future success of the
Company's marketed products Aphthasol(R) and products
in development including polymer platinate, OraDisc(TM)
and our Mucositis technology, our ability to develop
products from our platform technologies, our ability to
manufacture amlexanox products in commercial
quantities, our sales projections and the sales
projections of our licensing partners, our ability to
achieve licensing milestones and other risks detailed
in the Company's Annual Report on Form 10-K for the
year ended December 31, 2003, and other reports filed
by us with the Securities and Exchange Commission.
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