Cellceutix Informed by FDA That 505(b)(2) Application Would Be an Acceptable
Approach for Its Psoriasis Drug
BEVERLY, MA, Jun 13, 2012 (MARKETWIRE via COMTEX) -- Cellceutix Corporation
(CTIX) (the "Company"), a biopharmaceutical company focused on discovering small
molecule drugs to treat unmet medical conditions, including drug-resistant
cancers and autoimmune diseases, reports today that it has participated in a
meeting with the U.S. Food and Drug Administration ("FDA") pertaining to the
Company's psoriasis compound, Prurisol(TM). As previously disclosed on April 16,
2012, the Company had requested the meeting for guidance on its initiatives to
seek a section 505(b)(2) designation for Prurisol(TM), which would allow the
Company to forgo early-stage trials and advance Prurisol(TM) into latter-stage
clinical trials.
Cellceutix is extremely pleased to announce that the FDA has informed the Company
that a 505(b)(2) application would be an acceptable approach for Prurisol(TM).
"It was a very productive meeting with the FDA providing us with valuable advice
about advancing Prurisol(TM) down the regulatory pathway," commented Cellceutix
CEO Leo Ehrlich. "Now we will begin the preparatory work necessary for a Phase 2
clinical trial application for Prurisol(TM) based upon the FDA guidance. The
recent activity of Steifel Labs, a GlaxoSmithKline company, spending
approximately $350 million to acquire rights to skin treatment drugs still in
development from Welichem Biotech and Basilea Pharmaceutica demonstrates how
valuable and in high demand new dermatological drugs are right now. This is a
very exciting time for Cellceutix and its shareholders as we transition from
pre-clinical to clinical with drugs that have incredible potential."
Cellceutix has previously disclosed images of mice treated with Prurisol(TM)
demonstrating its effectiveness as compared to methotrexate, a standard care
treatment for psoriasis today. More information on Prurisol(TM) and those images
can be found at:
cellceutix.com.
About Psoriasis
According to the National Psoriasis Foundation, psoriasis is a chronic,
autoimmune disease that appears on the skin. It occurs when the immune system
sends out faulty signals that speed up the growth cycle of skin cells. Psoriasis
is the most prevalent autoimmune disease in the United States, affecting as many
as 7.5 million people, or 2.2 percent of the U.S. population, with associated
costs of $11.25 billion annually. According to the World Psoriasis Day
consortium, as many as 125 million people worldwide (2 to 3 percent of the
Earth's population) have psoriasis.
About Cellceutix
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company
under the symbol "CTIX". It is an emerging bio-pharmaceutical company focused on
the development of its pipeline of compounds targeting areas of unmet medical
need. Our flagship compound, Kevetrin(TM), is an anti-cancer drug which has
demonstrated the ability in pre-clinical studies to regulate the p53 pathway and
attack cancers which have proven resistant to today's cancer therapies
(drug-resistant cancers). Cellceutix also owns the rights to seven other drug
compounds, including KM-133, which is in development for psoriasis, and KM-391
for the treatment of the core symptoms of autism. More information is available
on the Cellceutix web site at cellceutix.com.
Safe Harbor Forward-Looking Statements
To the extent that statements in this press release are not strictly historical,
including statements as to revenue projections, business strategy, outlook,
objectives, future milestones, plans, intentions, goals, future financial
conditions, future collaboration agreements, the success of the Company's
development, events conditioned on stockholder or other approval, or otherwise as
to future events, such statements are forward-looking, and are made pursuant to
the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. The forward-looking statements contained in this release are subject to
certain risks and uncertainties that could cause actual results to differ
materially from the statements made. Factors that may impact Cellceutix's success
are more fully disclosed in Cellceutix's most recent public filings with the U.S.
Securities and Exchange Commission.
Cellceutix Corp.
Leo Ehrlich
(978) 236-8717
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