Apricus Biosciences Files Phase 3 Registration Protocol for PrevOnco™ for Special Protocol Assessment Consideration by the FDA
November 22 2010 - 10:13AM
Business Wire
Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) today
announced that it has filed the protocol for a proposed Phase 3
clinical trial of PrevOnco™, its proprietary treatment for
hepatocellular carcinoma (liver cancer), with the U.S. Food and
Drug Administration (FDA). The FDA will review the protocol under
its Special Protocol Assessment (SPA) program, under which the FDA
would give approval for the trial’s design, clinical endpoints and
statistical analysis. The Phase 3 study is expected to take about
12-24 months depending on the recruitment of patients. If the trial
shows positive results within the parameters agreed upon in the
SPA, the data would then be expected to provide the basis for the
filing of a New Drug Application for marketing approval of PrevOnco
in the U.S.
The FDA granted PrevOnco Orphan Drug status in August 2008. The
product incorporates lansoprazole, a commonly marketed anti-ulcer
compound which has shown strong anti-cancer activity in mice
bearing human liver tumors. The Phase 3 study will enroll up to 218
patients who have advanced, unresectable hepatocellular carcinoma
who no longer respond to Nexavar® (the currently marketed
first-line anti-cancer treatment for patients with this type of
liver cancer). The subjects will receive Nexavar and doxorubicin
(the widely used chemotherapy anti-cancer drug), plus either
PrevOnco or a placebo. Nexavar is marketed in the U.S. by Onyx
Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc.,
with close to $1 billion in sales, and is approved in more than 90
countries for the treatment of patients with hepatocellular
carcinoma.
Dr. Bassam Damaj, President and Chief Executive Officer of
Apricus Bio, noted, "Fifteen years worth of experience using
lansoprazol to treat ulcers has shown that the drug is safe for
human use. We have also seen strong anti-cancer activity in mice
bearing human liver tumors. As a result, we are optimistic that
PrevOnco to do well in the clinic.”
In addition, the Company has developed a new, oral lansoprazole
formulation incorporating its clinically validated, proprietary
NexACT® drug delivery technology, which is designed to potentially
reduce the lansoprazole dose needed in humans by seven times, based
on data generated in non-human primate studies. The Company may
seek FDA approval to switch the current lansoprazole formulation
with the NexACT formulation of lansoprazole following a Phase I
human pharmacokinetic equivalency bridging study.
About Special Protocol
Assessment
The FDA's Special Protocol Assessment process was implemented
under the Prescription Drug User Fee Act (PDUFA) in November
1997. The SPA process provides for review and a binding agreement
that the Phase III trial protocol design, clinical endpoints,
planned conduct and statistical analyses are acceptable to support
regulatory approval.
About Apricus
Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue
generating CRO business, Apricus Bio has leveraged the flexibility
of its proven NexACT® drug delivery technology to enable
multi-route administration of new and improved compounds across
numerous therapeutic classes. Future growth is expected to be
driven primarily through out-licensing of this technology for the
development and commercialization of such compounds to
pharmaceutical and biotechnology companies, worldwide.
Concurrently, the Company is seeking to monetize its existing
product pipeline, including its approved drug erectile dysfunction
treatment, Vitaros®, as well as compounds in development from
pre-clinical through Phase 3, currently focused on dermatology,
sexual dysfunction and cancer. For further information on Apricus
Bio and its subsidiaries, visit http://www.apricusbio.com.
Forward-Looking Statement Safe
Harbor
Statements under the Private Securities Litigation Reform Act:
with the exception of the historical information contained in this
release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may
individually or mutually impact the matters herein described for a
variety of reasons that are outside the control of the Company,
including, but not limited to, approval of the proposed SPA, the
Company’s capital resources needed to fund any clinical trials, the
Company’s ability to replicate pre-clinical study results in
subsequent human clinical studies and the rate of patient
enrollment in any clinical studies. Readers are cautioned not to
place undue reliance on these forward-looking statements as actual
results could differ materially from the forward-looking statements
contained herein. Readers are urged to read the risk factors set
forth in the Company's most recent annual report on Form 10-K and
subsequent quarterly reports filed on Form 10-Q. Copies of these
reports are available from the SEC's website or without charge from
the Company.
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