Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program
03 Agosto 2009 - 5:00AM
PR Newswire (US)
Enrolling Ovarian Cancer Patients in France; Finalizing Clinical
Trial Programs with Partners in China and Korea DALLAS, Aug. 3
/PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC:ACCP)
(BULLETIN BOARD: ACCP) , provided an update today on its clinical
development strategy for ProLindac, a novel DACH platinum drug that
has shown to be active in many solid tumors in human clinical
studies. Access has commenced a new clinical study of ProLindac in
France. The study will examine dose levels and regimens of
ProLindac monotherapy in cancer patients, provide additional data
to support design of combinations studies, and extend the safety
database. Two ovarian cancer patients have been enrolled in the
study to date, and it is anticipated 6 to 12 patients will be
enrolled this year in advance of enrolling patients in trial
evaluating ProLindac in combination with other chemotherapies.
Access recently announced data from a recurrent ovarian cancer
trial that showed that ProLindac was more active than currently
available platinum drugs in that patient population, and that the
drug was very well tolerated. ProLindac is a novel DACH platinum
drug that has shown to be active in many solid tumors in human
clinical studies. Platinum drugs are one of the most clinically and
commercially successful class of chemotherapies and generated more
than $3 billion in revenue globally in 2008. Access believes that
ProLindac, as a well-tolerated and active DACH platinum, represents
a important improvement in the design and tolerability of platinum
chemotherapies. Later this month, an Access management and clinical
development team is meeting with Access' partner, Aosaikang
Medicinal Group (ASK) and several key oncology opinion leaders to
finalize plans for ProLindac development in China. In addition,
Access is meeting with its Korean partner, JCOM of Seoul, South
Korea to finalize development plans in that territory. Access
believes that three ProLindac combination trials will start shortly
upon regulatory approvals of protocols in both China and Korea.
Further, Access has reported receipt of additional milestone
payments from its Far East partners in the ordinary course under
their collaborative agreements. "Our Chinese partner, ASK, has made
great progress on manufacturing scale-up of ProLindac and advancing
the Regulatory process with the SFDA. We are excited about
finalizing protocols with ASK and the leading oncologists in China,
and look forward to their continued progress," stated Jeffrey B.
Davis, Access' President and CEO. "Additionally, we are meeting
this month with JCOM and key opinion leaders in Korea, and hope to
get the combination trials started in Korea as soon as reasonably
possible." Access intends to design all clinical studies of
ProLindac in accordance with FDA standards and intends to use the
clinical data from all three planned clinical trials in the Far
East to further development in North America and Europe. Access has
the right to all clinical data generated in the Far East under the
agreements entered into with their Far East partners, and as
previously announced, believes that these trials run by its
ProLindac partners will save Access between $20 and $30 million in
clinical development expenses. Access is currently in discussion
with potential partners for development and commercialization of
ProLindac in additional territories. About ProLindac(TM): ProLindac
is a novel DACH platinum prodrug which has been shown to be active
in a wide variety of solid tumors in both preclinical models and in
human trials. Access believes that ProLindac's unique molecular
design potentially could eliminate some of the toxic side effects
seen in the currently marketed DACH platinum, Eloxatin, which has
sales in excess of $2 billion. Access has previously announced that
it has licensed ProLindac to Aosaikang Medicinal Group ("ASK") for
the Greater China Region and to JCOM, Ltd for South Korea. Under
these agreements both of these partners will be conducting Phase 2
combination studies with ProLindac in specific tumor types at their
expense based on these results. About Access: Access
Pharmaceuticals, Inc. is an emerging biopharmaceutical company that
develops and commercializes propriety products for the treatment
and supportive care of cancer patients. Access' products include
ProLindac(TM), currently in Phase 2 clinical testing of patients
with ovarian cancer, and MuGard(TM) for the management of patients
with mucositis. The company also has other advanced drug delivery
technologies including Cobalamin(TM)-mediated targeted delivery and
oral drug delivery, its proprietary nanopolymer delivery technology
based on the natural vitamin B12 uptake mechanism; Angiolix , a
humanized monoclonal antibody which acts as an anti-angiogenesis
factor and is targeted to breast cancer; and Thiarabine, a new
generation nucleoside analog which has demonstrated both
pre-clinical and clinical activity in certain cancers. For
additional information on Access Pharmaceuticals, please visit our
website at http://www.accesspharma.com/. 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. These statements include
those relating to: clinical trial plans and timelines and clinical
results for ProLindac and product candidates acquired in the
MacroChem transaction, our ability to execute licensing agreements
in the future, Access' plans to continue and initiate clinical
trials, the value of its products in the market (including MuGard
and the size of the overall market for mucositis products), its
ability to achieve clinical and commercial success and its ability
to successfully develop marketed products. These statements are
subject to numerous risks, including but not limited Access' need
to obtain additional financing in order to continue the clinical
trial and operations and to the risks detailed in Access' Annual
Reports on Form 10-K and other reports filed by Access with the
Securities and Exchange Commission. DATASOURCE: Access
Pharmaceuticals, Inc. CONTACT: Stephen B. Thompson, Vice President,
Chief Financial Officer of Access Pharmaceuticals, Inc.,
+1-214-905-5100; or Investor Relations, Donald C. Weinberger or
Diana Bittner (media), both of Wolfe Axelrod Weinberger Assoc. LLC,
+1-212-370-4500 for Access Pharmaceuticals, Inc. Web Site:
http://www.accesspharma.com/
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