Pro (AMEX:PRW)
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The senior management of Pro-Pharmaceuticals, Inc. (AMEX: PRW),
has outlined strategic initiatives that will reallocate corporate
resources in order to extend the Company’s
cash runway and fund operations into December. The Company anticipates a
505 (b)(2) New Drug Application (“NDA”)
with the U.S. Food and Drug Administration (“FDA”)
for DAVANAT® with
5-FU to treat advanced colorectal cancer with revenues to follow in 2009.
As per the initiatives, the Company is focusing its resources on its NDA
filing and the commercialization of DAVANAT®.
To date, there has been a significant reduction in operating expenses
that extend the Company’s cash runway into
December. On the short list of cost reductions targets, the Company has
eliminated non-core expenses; significantly reduced management
compensation; lowered legal and accounting expenses and consulting fees;
and reduced research and development and clinical trial expenses in
order to focus on the PK study needed to file the NDA and has halted its
Phase II, line l, biliary cancer trial.
“These cost cutting steps will better
position the Company to achieve our near-term goal of commercializing
DAVANAT® by 2009,”
said Pro-Pharmaceuticals CEO David Platt, PhD. “We
are absolutely convinced that DAVANAT®
is critical to the many patients suffering from advanced
colorectal cancer. Regardless of the difficulties that we must overcome,
we remain completely focused on achieving our goal.”
As recently announced, the Company has requested a meeting with the FDA
to review the PK study needed to complete the NDA filing. Results of
pre-clinical studies show that there is more 5-FU accumulation in the
tumor when co-administered with DAVANAT®
than when 5-FU is administered alone. These studies coupled with
clinical trial data further support that DAVANAT®
is safe, non-toxic, and improves the efficiency of 5-FU with no
increase in toxicity while significantly reducing associated known side
effects.
“In light of our present cash position and
funding requirement, we made a strategic decision to submit DAVANAT®
to the FDA under 505 (b)(2); thus, reducing dramatically the time and
costs associated to obtain regulatory approval,”
Dr. Platt continued.
“It is paramount we continue our projects
without interruption in order to achieve sales of our lead drug
candidate DAVANAT®
in 2009. Hence, we are actively pursuing financing options and, although
there are no assurances, we are confident that we will receive the funds
needed to complete the submission for DAVANAT®,
further our efforts on our other drug and delivery platforms, and
increase shareholder value,” Dr. Platt
concluded.
The Company is using 505 (b)(2) to obtain more timely and efficient
marketing approval of new formulations of previously approved
chemotherapeutics in combination with the Company’s
proprietary drug. The Company is seeking approval for co-administration
of DAVANAT®, a new
chemical entity, with FDA-approved 5-FU for intravenous injection for
the treatment of cancer.
DAVANAT® is a
galactomannan, a class of drugs approved by the FDA for oral and topical
use. 5-FU is one of the most widely used chemotherapy drugs in the world
and is used to treat various types of cancers, including colorectal,
breast, and gastrointestinal. Additional 505(b)(2) filings are planned
for DAVANAT® with
other chemotherapeutics and biologics.
About DAVANAT®
DAVANAT®, a new
chemical entity, is a proprietary carbohydrate compound that is
administered with chemotherapies and biologics to treat cancer. DAVANAT®'s
mechanism of action is based on binding to lectins. DAVANAT®
targets specific lectin receptors (Galectins) on cancer cells.
Current research indicates that Galectins affect cell development and
play important roles in cancer, including tumor cell survival,
angiogenesis and tumor metastasis.
Pro-Pharmaceuticals, Inc. – Advancing
Drugs Through Glycoscience®
Pro-Pharmaceuticals is engaged in the discovery, development, and
commercialization of carbohydrate-based, targeted therapeutics for
advanced treatment of cancer, liver, microbial, and inflammatory
diseases. Initially, the product pipeline is focused on developing
targeted therapeutics to treat cancer. The Company’s
technology also is being developed to explore the treatment of liver and
kidney fibrosis. The Company is headquartered in Newton, Mass.
Additional information is available at www.pro-pharmaceuticals.com.
FORWARD LOOKING STATEMENTS
Any statements in this news release about future expectations, plans and
prospects for the Company, including without limitation, statements
containing the words believes, anticipates, plans, expects, and similar
expressions, constitute forward-looking statements as defined in the “safe
harbor” provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
based on management’s current expectations
and are subject to a number of factors and uncertainties, which could
cause actual results to differ materially from those, described in such
statements. We caution investors that actual results or business
conditions may differ materially from those projected or suggested in
forward-looking statements. More information about those risks and
uncertainties is contained in the Company’s
most recent quarterly or annual report and other reports filed with the
Securities and Exchange Commission. While the Company anticipates that
subsequent events may cause the Company’s
views to change, the Company disclaims any obligation to update such
forward-looking statements.
DAVANAT and Advancing Drugs Through Glycoscience are registered
trademarks of Pro-Pharmaceuticals.