Drug Discovery & Development - March 08, 2011
Toxikon Corp., a pre-clinical contract research organization with facilities in the US and in Leuven, Belgium, has completed toxicity studies in two species for Cellceutix Corp.’s Kevetrin, a compound the Beverly, Mass.-based firm is developing for the treatment of resistant lung and breast cancers. Toxikon also performed safety pharmacology studies of Kevetrin in the central nervous system as well as the cardiovascular and respiratory systems.
The toxicity studies, required for an Investigational New Drug (IND) filing, involved administering Kevetrin to two species of animals weekly over a 29-day period. In each study, 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. The studies are designed to confirm that Kevetrin meets FDA safety requirements for clinical studies in humans.
“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.”
“Along with safety studies, we can assist with synthesis of intermediates from milligrams to hundreds of grams,” said Dr. Desai, the former director of anti-cancer drug research at Boston’s Dana Farber Cancer Institute. “We are also poised to develop small novel molecules for the treatment of cancer and viral diseases.”
“We are very delighted with the results of the toxicity studies performed at Toxikon,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “While we were confident that the results would be positive, it is always reassuring to see the actual results. We are also grateful to Toxikon for the high quality of their work and excellent customer focus. We have now taken a major step forward toward our phase 1 clinical trial, to be conducted at a major cancer center in the Boston area.”
In animal studies, Kevetrin was found to significantly delay tumor growth in multi-drug resistant lung, breast and colon cancer cell lines. In data presented in April, 2010 at the American Association for Cancer Research, the efficacy of Kevetrin in a mouse model of drug resistant lung cancer was shown to increase with increasing dose. The data presented at the AACR also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance.
Date: November 2, 2010
Source: Toxikon Corp.
The toxicity studies, required for an Investigational New Drug (IND) filing, involved administering Kevetrin to two species of animals weekly over a 29-day period. In each study, 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. The studies are designed to confirm that Kevetrin meets FDA safety requirements for clinical studies in humans.
“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.”
“Along with safety studies, we can assist with synthesis of intermediates from milligrams to hundreds of grams,” said Dr. Desai, the former director of anti-cancer drug research at Boston’s Dana Farber Cancer Institute. “We are also poised to develop small novel molecules for the treatment of cancer and viral diseases.”
“We are very delighted with the results of the toxicity studies performed at Toxikon,” said Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “While we were confident that the results would be positive, it is always reassuring to see the actual results. We are also grateful to Toxikon for the high quality of their work and excellent customer focus. We have now taken a major step forward toward our phase 1 clinical trial, to be conducted at a major cancer center in the Boston area.”
In animal studies, Kevetrin was found to significantly delay tumor growth in multi-drug resistant lung, breast and colon cancer cell lines. In data presented in April, 2010 at the American Association for Cancer Research, the efficacy of Kevetrin in a mouse model of drug resistant lung cancer was shown to increase with increasing dose. The data presented at the AACR also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance.
Date: November 2, 2010
Source: Toxikon Corp.
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