SOURCE: Cellceutix

June 14, 2010 06:00 ET

New Autism Drug Research by Cellceutix on Compound KM-391 Results in Significant Behavioral Changes; Chief Scientific Officer Sees Potential for Company to Emerge as Industry Leader as Pharmas Strive for Revolutionary Autism Treatments

BEVERLY, MA--(Marketwire - June 14, 2010) -  Cellceutix Corporation (OTCBB: CTIX) announced today that a new animal study of its compound for autism spectrum disorder, KM-391, once again demonstrated a positive impact on several measures of behavior associated with autism. As announced last week, Cellceutix expedited the research through a collaborative effort with InterEd Faculty of Clinical Research (IFCR) in India and the prestigious Cochin University of Science & Technology (CUSAT).

In the study, test subjects previously injected with a compound to simulate autistic behaviors were injected with an oxytocin antagonist to intensify the symptoms. Test subjects were divided into four groups, oxytocin antagonist only, oxytocin antagonist plus KM-391 (10 mg/kg), placebo alone and placebo plus KM-391 (10 mg/kg). Measurements were taken of autism related behaviors including: repetitive behavior, self-induced injury, sensitivity to touch, positioning correction, group dynamics, and curiosity. The procedure was repeated with the same animals on days 5 and 10. When KM-391 was given along with the oxytocin antagonist, there was a significant reduction in all 6 autism-related behaviors within 1 to 2 hours.

"We are extremely excited about the results from this phase of testing as it coincides with the previous research," said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Having been involved in the research and development of extremely successful compounds in the past, I am very encouraged by the research results that we are achieving with KM-391 and its development potential as a treatment for autism. In our testing, we have simulated specific characteristics of an autistic brain and behavioral symptoms that result from them. KM-391 has been shown to significantly improve both the physical conditions in the brain and behaviors resulting in our animal models. We now have a basis to expect to emerge as a pharma industry leader in autism."

Initial animal model testing on autism conducted with KM-391 by Cellceutix provided exciting results. In a carefully conducted study, KM-391 was given orally over 90 days to groups of rats at two dosage levels. At each dosage level, KM-391 demonstrated significant improvements in the test animals when compared to both the "no treatment" group and the "active control" (fluoxetine) group on the parameters of brain plasticity, serotonin levels and behavioral function. These parameters were selected as important indicators of the effect needed to successfully treat autism.

"With Pfizer and Novartis recently announcing that they have begun pursuing new treatments for core issues of autism, we are excited to be ahead of the curve," said Leo Ehrlich, CFO of Cellceutix. "The latest research has significantly strengthened the previous data and this puts Cellceutix in the forefront of autism research. While we have already been receiving notoriety in the industry, we believe that this is just the beginning of great things to come for Cellceutix and its shareholders."

More information about this new study is available on the Cellceutix web site at www.cellceutix.com.

About Autism Spectrum Disorders:

Autism is a behavior disorder, characterized by an impairment in social communication, social interaction, and social imagination. Those with autism often have a restricted range of interests and display repetitive behaviors and mannerisms, along with altered reactions to the everyday environment.

More information about autism:

  • 1 percent of the population of children in the U.S. ages 3-17 have an autism spectrum disorder. Prevalence is estimated at 1 in 110 births.
  • More children will be diagnosed with autism this year than with AIDS, diabetes & cancer combined.
  • 1 to 1.5 million Americans live with an autism spectrum disorder. 1 percent of the adult population of the United Kingdom have an autism spectrum disorder.
  • Fastest-growing developmental disability; 10 - 17 % annual growth.
  • $60 billion estimated annual cost with 60% of costs in adult services. Cost of lifelong care can be reduced by 2/3 with early diagnosis and intervention.
  • Autism receives less than 5% of the current US private research funding, and less than 1% of the total NIH budget, even though it is the most prevalent childhood disorder.

More information about autism spectrum disorders is available on the following websites:

National Institute of Child Health and Human Development (NICHD) -- http://www.nichd.nih.gov

Autism Society of America -- http://www.autism-society.org

Autism Speaks, Inc. -- http://www.autismspeaks.org

About Cellceutix
Cellceutix Corporation is a preclinical cancer, autism and anti-inflammatory drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin™, which it is developing as a treatment for drug-resistant cancers, and KM-391, which it is developing for the treatment of autism. More information is available on the Cellceutix web site at www.cellceutix.com.

This Press Release contains forward-looking statements that are based on our current expectations, beliefs and assumptions about the industry and markets in which Cellceutix Corporation operates. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause Cellceutix's actual results to be materially different from any future results expressed or implied by these statements. Actual results may differ materially from what is expressed in these statements, and no assurance can be given that Cellceutix can successfully implement its core business strategy and improve future earnings.

The factors that may cause Cellceutix's actual results to differ from its forward-looking statements include: Cellceutix's current critical need for additional cash to sustain existing operations and meet ongoing existing obligations and capital requirements; Cellceutix's ability to implement its new product development and commercialization, enter into clinical trials, expand the intellectual property portfolio, and receive regulatory approvals in a timely and cost-effective manner. All forward-looking statements are also expressly qualified in their entirety by the cautionary statements included in Cellceutix's SEC filings, including its quarterly reports on Form 10-Q and its annual report on Form 10-K.

Kevetrin and KM-391 have not been studied in humans at this time. The Company's positive results in animal studies do not necessarily guarantee success in humans, though they may form the basis for beginning Phase 1 trials.

Contact Information

  • Contact:
    Cellceutix Corp.
    Leo Ehrlich
    CFO
    (978) 633-3623
    Email Contact