Cellceutix continues to move forward with developments of KM-391, their compound for the treatment of autism. The press release states how they were able to pool some resources and expedite pre-clinical testing of KM-391. It appears that the word is out about a new treatment for autism being possible and the world is reaching out to Cellceutix and they are responding.
The second part of the press release is about the final piece of the puzzle to move forward towards the IND filing for Kevetrin. The time is near.
Cellceutix Responds to Public Support by Expediting Autism Studies; Completes Two Required Safety Pharmacology Studies for Its Cancer Compound
Press Release Source: Cellceutix On Monday June 7, 2010, 6:00 am EDT
BEVERLY, MA–(Marketwire – 06/07/10) – Cellceutix Corporation (OTC.BB:CTIX – News) is pleased to announce its acknowledgment of the many emails, phone calls and letters received regarding KM-391, its novel compound for the treatment of autism. Responding to the public’s requests, Cellceutix has drawn upon its many resources and expedited scheduling of additional pre-clinical studies of the compound with the results to be released in upcoming weeks.
Cellceutix worked in cooperation with the world-renowned InterEd Faculty of Clinical Research (IFCR) in India to move rapidly in the development of KM-391. The Company’s President and Chief Scientific Officer, Dr. Krishna Menon, as Chancellor of IFCR, was able to request expedited scheduling for the testing of KM-391. The prestigious Cochin University of Science & Technology (CUSAT) followed suit and conducted the testing. The research has been completed and the data is presently being analyzed and will soon be ready for release.
“Through a great collaborative effort between our team at Cellceutix with InterEd and Cochin University, we were able to reduce scheduling time from months to weeks,” commented George Evans, Chief Executive Officer of Cellceutix. “Our years of experience in the industry have provided us with valuable resources that were very supportive in our efforts to respond to the critical need for new autism treatments.”
The Company previously reported that initial testing conducted with KM-391 on a mouse model has provided promising data. 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. Being that KM-391 is a novel compound and not merely a derivative of an existing compound, it is in the spotlight within the autism community and the focus of many communications to Cellceutix regarding its development.
Cellceutix Completes Two Required Safety Pharmacology Studies for its Cancer Compound, Kevetrin
Cellceutix Corporation also announces today that it has completed two animal safety pharmacology studies for its cancer compound, Kevetrin™, that are required by the U.S. Food and Drug Administration (FDA) prior to filing an Investigational New Drug (IND) application. These studies involve assessments of the impact of the administration of a compound on the respiratory and central nervous systems of test animals. In the respiratory study, respiratory rate, tidal volume and minute volume were measured. In the central nervous system study, neuropharmacological effects and effects on body temperature were measured. A cardiovascular safety pharmacology study is nearing completion.
“The results of these studies are very encouraging for the further development of Kevetrin,” said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. “The respiratory and central nervous system studies showed no biologically significant changes compared to controls. Since these studies are required by the FDA for an IND filing, their completion is a major forward step for us.”
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 certain 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.