Access Pharmaceuticals Announces Completion of ProLindac Monotherapy Trial and Initiation of Combination Study
January 07 2010 - 8:30AM
PR Newswire (US)
Update on Worldwide Development on ProLindac DALLAS, Jan. 7
/PRNewswire-FirstCall/ -- ACCESS PHARMACEUTICALS, INC. (OTC
Bulletin Board: ACCP), today announced that it has completed
enrollment and evaluation of the last additional cohort of patients
in the ongoing clinical study of ProLindac as a monotherapy in
ovarian cancer patients who have received at least two prior
platinum based treatment regimens. The additional cohort of 8
patients received the ProLindac batch made by an improved scalable
process, which will be used on a larger scale for future clinical
and commercial supplies. None of the 8 patients experienced any
acute significant adverse events, while treatment had the same
beneficial pharmacodynamic effect seen in the first 26 patients
treated with the former ProLindac production batch; clinically
relevant sustained biomarker decrease (responses by Rustin's
criteria) and disease stabilization were seen in several patients.
The overall results of our Phase I/II exploratory single agent
ProLindac study have helped define multiple safe dosing regimens,
while the level of patient cohort accrued in the study antitumor
activity was as expected in this very heavily pretreated patient
cohort. Based on these results, Access is initiating a study of
ProLindac combined with Paclitaxel in second line treatment of
platinum pretreated advanced ovarian cancer patients. This study is
the first to look at the safety and efficacy of ProLindac in
combination with other oncology agents. "The efficacy of Diamino
Cyclohexane Platinum, the active principle in ProLindac, is
evidenced mainly through their synergic association with multiple
anticancer agents. The choice of Paclitaxel and ovarian cancer as
the potential first NDA strategic choice to be explored is based on
the excellent results of the Paclitaxel/Oxaliplatin combination in
the same clinical setting. This multi-center study of up to 25
evaluable patients will be conducted in Europe. The very ambitious
primary efficacy endpoint goal is to achieve a minimum of 63%
response rate in the total of 25 evaluable patients the study is
planning to accrue on a two step design. We are very reassured and
pleased with these results and the quality of the latest scalable
process product, which is driving us towards an ambitious NDA
strategy with an exploratory trial based upon the well known
synergistic power of DACH platinums with a variety of anticancer
agents," stated Prof. Esteban Cvitkovic, Vice Chairman of Access
and a clinical oncologist overseeing the combination study in
Europe. "We are confident that ProLindac in combination with
Paclitaxel will be well tolerated in this patient population and
anticipate significant activity based on our current experience
with ProLindac in heavily pretreated patients." "This first
combination study is a major milestone for ProLindac and Access
Pharmaceuticals. We believe the data generated by the combination
study will demonstrate that this combination can be an effective
treatment option for patients with hard to treat late stage ovarian
cancer," stated Jeffrey B. Davis, President & CEO of Access.
"Our efforts, combined with the efforts of our Asian partners, are
targeted at demonstrating the safety and efficacy of ProLindac in
multiple combination treatment protocols for a range of cancer
types. We believe ProLindac is new DACH platinum chemotherapy in
continued clinical development at this stage." Access' Asian
partners continue to prepare regulatory and other filings in South
Korea and China to commence additional combination clinical studies
with ProLindac. These studies are expected to provide clinical data
for additional indications for ProLindac beyond late stage ovarian
cancer. Additional indications under consideration include
hepatocellular carcinoma, pancreatic, endometrial and others. 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 Jiangsu
Aosaikang Pharmaceutical Co., Ltd. ("ASK") for the Greater China
Region and to JCOM, Ltd for South Korea. Under these agreements
both of these partners will be conducting 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 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: Company, Stephen B. Thompson, Vice
President, Chief Financial Officer of Access Pharmaceuticals, Inc.,
+1-214-905-5100; or Investor Relations, Donald C. Weinberger/Diana
Bittner (media) of Wolfe Axelrod Weinberger Assoc. LLC,
+1-212-370-4500, for Access Pharmaceuticals, Inc. Web Site:
http://accesspharma.com/
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