Pro-Pharmaceuticals' Management Outlines Strategic Initiatives
September 18 2008 - 7:00AM
Business Wire
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.
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