Access Pharmaceuticals Provides Update on ProLindac(TM)Clinical Development Plan
10 Septiembre 2009 - 8:00AM
PR Newswire (US)
Finalizing Plans for Combination Studies in Liver, Pancreatic and
Ovarian Cancers DALLAS, Sept. 10 /PRNewswire-FirstCall/ -- ACCESS
PHARMACEUTICALS, INC. (OTC:ACCP) (BULLETIN BOARD: ACCP) , provided
an update today on the Company's clinical development plan for
ProLindac, a novel DACH platinum drug that has shown to be active
in many solid tumor types in human clinical studies. Access'
clinical development team recently met with its partners Aosaikang
Medicinal Group (ASK) in Nanjing, China and JCOM, Ltd. ("JCOM") in
Seoul, Korea, together with key opinion leaders in oncology
indications to discuss the protocols for the three planned
ProLindac combination studies. Access and its partners are
finalizing development plans and protocols for clinical trials
strategically designed to examine ProLindac in combination with
gemcitabine and/or taxol in hepatocellular carcinoma (a form of
liver cancer), pancreatic cancer and recurrent ovarian cancer.
Access previously announced positive safety and efficacy results
from its Phase 2 monotherapy clinical study of ProLindac(TM) in
late-stage, heavily pretreated ovarian cancer patients. In this
study, 66% of patients who received the highest dose achieved
clinically meaningful disease stabilization according to RECIST
criteria. No patient in any dose group exhibited any signs of acute
neurotoxicity, which is a major adverse side-effect of the approved
DACH platinum, Eloxatin, and ProLindac was well tolerated overall.
The recent Phase 2 recurrent ovarian study explored three different
dose levels and two dosing regimens of ProLindac as a monotherapy
treatment for advanced ovarian cancer, to provide data on the
monotherapy anticancer activity and safety of ProLindac. Of
patients eligible for evaluation according to standard RECIST
criteria, clinically-meaningful disease stabilization was achieved
in 42% of all patients, and 66% of all patients in the higher dose
groups. Sustained and significant reductions in Ca-125, the
established specific serum marker for ovarian cancer, were also
observed in several patients. "Access is extremely pleased with the
clinical progress to date, and look forward to initiation of
clinical trials looking at ProLindac in combination with commonly
used chemotherapies," stated Jeffrey Davis, President & CEO.
"Our partners in the Far East hosted Access together with key
opinion leaders in oncology indications to discuss various
potential protocol options, and hope to start enrolling patients in
up to three combination trials by the end of the year, depending
upon regulatory approvals of the trial protocols and certain other
matters." 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. Contact: Company Contact:
Investor Relations Stephen B. Thompson Donald C. Weinberger/Diana
Bittner (media) Vice President, Wolfe Axelrod Weinberger Assoc. LLC
Chief Financial Officer (212) 370-4500 Access Pharmaceuticals, Inc.
(214) 905-5100 DATASOURCE: Access Pharmaceuticals, Inc. CONTACT:
Stephen B. Thompson, Vice President, Chief Financial Officer of
Access Pharmaceuticals, Inc., +1-214-905-5100; or Donald C.
Weinberger, or Diana Bittner, both of Wolfe Axelrod Weinberger
Assoc. LLC, +1-212-370-4500, for Access Pharmaceuticals, Inc. Web
Site: http://www.accesspharma.com/
Copyright