Cellceutix Selects Dr. Reddy's Laboratories for Formulation of Brilacidin for Ophthalmic and Otitis Infections
February 24 2014 - 7:00AM
Marketwired
Cellceutix Selects Dr. Reddy's Laboratories for Formulation of
Brilacidin for Ophthalmic and Otitis Infections
New Laboratory Research Supports Potential of Brilacidin for
Middle Ear Infections
BEVERLY, MA--(Marketwired - Feb 24, 2014) - Cellceutix
Corporation (OTCQB: CTIX) (the "Company"), a clinical stage
biopharmaceutical company developing innovative therapies in
oncology, dermatology, and antibiotic applications, announces today
that the Company has concluded negotiations with formulation
developers and selected Dr. Reddy's Custom Pharmaceutical Services
(CPS), part of the Pharmaceutical Services and Active Ingredients
(PSAI) business unit of Dr. Reddy's Laboratories Ltd. ("Dr.
Reddy's"), a New York Stock Exchange-listed company traded under
the ticker "RDY", for the formulation of the Company's defensin
mimetic drug Brilacidin for use in ophthalmic and otitis
infections.
Laboratory research on Brilacidin conducted at the Charles T.
Campbell Ophthalmic Microbiology Laboratory demonstrated the
safety, tolerability and broad activity of Brilacidin against
drug-sensitive and drug-resistant clinical isolate strains of
ocular infections. Additional research by Contract Research
Organization Iris Pharma showed that Brilacidin has a high
residence time on the surface of the eye with negligible systemic
exposure, suggesting that Brilacidin has the potential to treat
ophthalmic infections, such as conjunctivitis and keratitis, with a
limited dosing regimen.
Cellceutix is pleased to report that in an ongoing study,
Brilacidin has shown excellent results in preliminary testing of
middle ear (otitis media) infection. In the study done in the
Chinchilla Model of Otitis Media, Brilacidin drastically reduced
the number of bacterial counts of Streptococcus pneumonia
in the middle ear and had no toxic effect. Chinchilla otitis models
are an excellent indicator if the drug will work in humans. We are
waiting for additional pathology results and additional testing is
planned. Once all data is confirmed, Cellceutix will publish
the results.
Acute otitis media is one of the most common pediatric illnesses
and also a leading cause of conductive hearing loss. About 2.2
million cases of otitis media with ear effusion occur annually in
United States. Over seven hundred million (700,000,000) cases of
acute otitis media occur worldwide each year.
Ear infection joins the growing list of indications of treatment
of disease in which Brilacidin has potent efficacy.
"We are presently in a Phase 2b trial with Brilacidin for
serious skin infections. Additional laboratory studies on
Brilacidin have been ongoing and I am pleased to say we are more
impressed than ever on the drug's potential. Due to the unique
properties of Brilacidin as a defensin mimetic and a possible
one-time or even a three-day drug treatment to patients, we see an
FDA approved Brilacidin for ABSSSI having the potential to knock
off the present market leader who is presently generating
approximately $1,000,000,000 in yearly sales. Expanding our
Brilacidin franchise as a potential new therapy for eye and inner
ear infections is a very important project for us as we view the
aggregate market potential for these indications as very
significant," comments Leo Ehrlich, Chief Executive Officer at
Cellceutix. "After undertaking an intense due diligence
process to identify the best formulator for the job, Dr. Reddy's
was the clear choice as they have shown a deep understanding of
what we want to accomplish. Their recent acquisition of
OctoPlus in the Netherlands was a big addition to their already
highly talented team as OctoPlus specializes in complex
formulations. We are extremely optimistic about Brilacidin for
ophthalmic and ocular indications based upon research to date and
look forward to having this potentially game-changing drug in more
clinical trials."
Commenting on this development, Dr. R Ananthanarayanan,
President, PSAI Business, Dr. Reddy's said, "Dr. Reddy's CPS has
extensive knowledge in manufacturing and formulating anti-infective
therapeutics. We are already working with Cellceutix on the
manufacturing of Prurisolâ„¢ and are excited to work with them on the
development of Brilacidin. Our expertise in both APIs and
formulation development will assist Cellceutix in the clinical
progression of Brilacidin."
About Dr. Reddy's Dr. Reddy's Laboratories Ltd. "NYSE: RDY" is
an integrated global pharmaceutical company, committed to providing
affordable and innovative medicines for healthier
lives. Through its three businesses -- Pharmaceutical Services
and Active Ingredients, Global Generics and Proprietary Products --
Dr. Reddy's offers a portfolio of products and services including
APIs, custom pharmaceutical services, generics, biosimilars,
differentiated formulations and NCEs. Therapeutic focus is on
gastro-intestinal, cardiovascular, diabetology, oncology, pain
management, anti-infective and pediatrics. Major markets
include India, USA, Russia and CIS, Germany, UK, Venezuela, S.
Africa, Romania, and New Zealand. For more information, log on
to www.drreddys.com.
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
being readied for clinical trials at sites in the U.S. and Europe.
Prurisol is a small molecule that acts through immune modulation
and PRINS reduction. Cellceutix's key antibiotic, Brilacidin, has
begun a Phase 2b trial in February 2014 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.
Contact:
Contact: INVESTOR AND MEDIA CONTACT: Cellceutix Corp. Leo
Ehrlich (978) 236-8717 Email
Contact
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