Cellceutix Completes Final Toxicity Study for Its Cancer Compound; United States FDA IND Application Underway
Published: Oct 28, 2010
BEVERLY, MA--(Marketwire - October 28, 2010) - Cellceutix Corporation (PINKSHEETS: CTIX) today announced that it has completed its second and final species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This is the last safety study required for an Investigational New Drug (IND) filing. In the study, animals were administered five doses of Kevetrin™ weekly over a 29 day period. Three groups of 14 animals were administered 5 mg/kg, 25 mg/kg and 60 mg/kg respectively while a fourth group acted as controls. There was a 14 day recovery period after the dosing. Parameters measured were hematology, clinical chemistries, weight change, food consumption, survival, urinalysis, ophthalmic examination and histopathology. This study, as well as the earlier toxicity and safety pharmacology studies, were performed by Toxikon, in Bedford, Massachusetts.
"This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results," said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies."
"This is an extraordinary milestone for a young company like ours," said George Evans, CEO of Cellceutix. "We would like to acknowledge our partner for these studies, Toxikon Corporation, who provided us with high quality work and excellent customer service. We believe we are now well on our way to an IND filing later this year or early next."
"We are proud to have led these important toxicology studies and help Cellceutix achieve its goal of getting Kevetrin to human trials and, ultimately, to market," said Dr. Laxman Desai, president and CEO of Toxikon, adding that "Toxikon is equipped to meet the industry's anticancer and antiviral drug discovery demands."
Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism 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.
Founded in 1977 and headquartered in Bedford, Massachusetts, Toxikon operates a 125,000 square foot state-of-the-art facility, where a complete range of services that facilitate the development of compounds, biologics and medical devices, achieve product safety and regulatory compliance, and maintain the highest levels of environmental and manufacturing quality control. Toxikon offers a comprehensive breadth of services, including acute, subchronic and chronic toxicity, reproductive toxicity, carcinogenicity, pharmacokinetics (PK), toxicokinetics (TK), bioavailability, ADME, extensive chemical characterization, impurities analysis and synthesis, bioanalytical, and microbiology. Additionally, Toxikon Europe, located in Leuven, Belgium, also operates a new state-of-the-art facility that was built in 2007. Toxikon Europe primarily focuses on analytical services, rapid microbiology, and in-vitro assays, including expanded microbiological capabilities. Toxikon's experienced lab management offers the highest quality of results that complies with the FDA, OECD, GLPs, ISO 17025 and many other globally recognized standards.
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.
Mark A. DeSorbo
781-275-3330, ext. 187