Cellceutix Comments on Positive FDA Advisory Vote for Dalbavancin and Tedizolid
April 01 2014 - 8:00AM
Marketwired
Cellceutix Comments on Positive FDA Advisory Vote for Dalbavancin
and Tedizolid
BEVERLY, MA--(Marketwired - Apr 1, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company") is pleased to comment to
its shareholders on yesterday's exciting regulatory developments
and how it impacts Cellceutix's drug, Brilacidin.
We are pleased to see yesterday's positive FDA Advisory
Committee vote for two antibiotics, dalbavancin and tedizolid,
which treat Acute Bacterial Skin and Skin Structure Infections
(ABSSSI) caused by Gram-positive organisms, such as Staph aureus.
Although the U.S. Food and Drug Administration (FDA) is not bound
to the recommendation of the advisory panel, if the drugs garner
FDA marketing approval, the tedizolid regimen would be once a day
for 6 days and the dalbavancin regimen would be one treatment
during the first week with a second dose required the following
week. This positive vote confirms the medical need for new drugs to
treat serious skin infections, which are often caused by
methicillin-resistant Staph aureus (MRSA), and most important for
Cellceutix, further indicates a clearly defined regulatory
pathway for antibiotic approvals.
These two drugs are actually new versions of already existing
drugs, and therefore, bacteria may develop
cross-resistance. That is, resistance already exists against
similar compounds from the same chemical family, and therefore
could potentially develop against the new compounds. We feel
confident that the medical community, as well as the FDA, will
fully embrace a new and innovative class of antibiotics, the
defensin-mimetics, of which Brilacidin is the lead candidate.
Because there is nothing else in the community that is similar to
Brilacidin, and due to its unique mechanism of action, we feel that
resistance is unlikely to develop against Brilacidin. In
addition, Brilacidin is currently being studied in a Phase 2b
clinical trial as a very short course regimen (1 to 3 days), which
provides advantages in terms of patient compliance and decreased
days of hospitalization. Currently, the shortest course regimen on
the market to treat ABSSSI is given once a day for 7 days. We
believe that among comparably priced drugs that are safe and
effective, the shortest course regimen will take over the
market.
About Cellceutix: Headquartered in Beverly, Massachusetts,
Cellceutix is a publicly traded company under the symbol "CTIX".
Cellceutix is a clinical stage biopharmaceutical company developing
innovative therapies in oncology, dermatology and antibiotic
applications. Cellceutix believes it has a world-class portfolio of
compounds and is now engaged in advancing its compounds and seeking
strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is
currently in a Phase 1 clinical trial at Harvard Cancer Centers'
Dana Farber Cancer Institute and Beth Israel Deaconess Medical
Center. In the laboratory Kevetrin has shown to induce activation
of p53, often referred to as the "Guardian Angel Gene" due to its
crucial role in controlling cell mutations. Cellceutix is planning
a Phase 2 clinical trial with its novel compound Brilacidin-OM for
the prevention and treatment of Oral Mucositis. Brilacidin-OM, a
defensin mimetic compound, has shown in the laboratory to reduce
the occurrence of severe ulcerative oral mucositis by more than 94%
compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is
presently in a bioequivalence crossover clinical trial in Miami,
FL. Prurisol is a small molecule that acts through immune
modulation and PRINS reduction. Cellceutix's key antibiotic,
Brilacidin, is in a Phase 2b trial for Acute Bacterial Skin and
Skin Structure Infections, or ABSSSI. Brilacidin has the potential
to be a single-dose therapy or a dosing regimen that is shorter
than currently marketed antibiotics for multi-drug resistant
bacteria (Superbugs). Cellceutix has formed research collaborations
with world-renowned research institutions in the United States and
Europe, including MD Anderson Cancer Center, Beth Israel Deaconess
Medical Center, and the University of Bologna. More information is
available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements This press release contains
forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
that involve risks, uncertainties and assumptions that could cause
Cellceutix's actual results and experience to differ materially
from anticipated results and expectations expressed in these
forward looking statements. Cellceutix has in some cases identified
forward-looking statements by using words such as "anticipates,"
"believes," "hopes," "estimates," "looks," "expects," "plans,"
"intends," "goal," "potential," "may," "suggest," and similar
expressions. Among other factors that could cause actual results to
differ materially from those expressed in forward-looking
statements are Cellceutix's need for, and the availability of,
substantial capital in the future to fund its operations and
research and development; including the amount and timing of the
sale of shares of common stock to Aspire Capital; the fact that
Cellceutix's compounds may not successfully complete pre-clinical
or clinical testing, or be granted regulatory approval to be sold
and marketed in the United States or elsewhere. A more complete
description of these risk factors is included in Cellceutix's
filings with the Securities and Exchange Commission. You should not
place undue reliance on any forward-looking statements. Cellceutix
undertakes no obligation to release publicly the results of any
revisions to any such forward-looking statements that may be made
to reflect events or circumstances after the date of this press
release or to reflect the occurrence of unanticipated events,
except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACT: Cellceutix Corporation Leo Ehrlich
(978) 236-8717 Email
Contact
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