Cellceutix Informed by FDA That 505(b)(2) Application Would Be an Acceptable Approach for Its Psoriasis Drug
June 13 2012 - 11:32AM
Marketwired
Cellceutix Corporation (OTCBB: 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™. 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™, which would
allow the Company to forgo early-stage trials and advance Prurisol™
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™.
"It was a very productive meeting with the FDA providing us with
valuable advice about advancing Prurisol™ 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™ 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™ demonstrating its effectiveness as compared to
methotrexate, a standard care treatment for psoriasis today. More
information on Prurisol™ and those images can be found at:
http://www.cellceutix.com/product-candidates/km-133---psoriasis-compound.html.
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™, 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 www.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 Email Contact
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