Aposense Ltd., a biopharmaceutical drug development company, has reported that its lead drug ATT-11T, designated primarily for the treatment of colorectal cancer, has successfully completed preclinical efficacy studies. The company also completed the development of an IV formulation suitable for administration to humans.
Dr Miri Ben-Ami, CEO of Aposense, said "ATT-11T demonstrates a clear advantage in efficacy over Irinotecan in several pre-clinical cancer models, and may provide a more precise and thus more effective treatment. We plan to meet with the FDA in the coming months to reach an agreement on the continued development plan including the design of the clinical study which we plan to initiate later this year."
ATT-11T is being developed under an agreement with Teva Pharmaceutical Industries, and is based on a conjugate of Irinotecan (a drug marketed under the commercial name "Camptosar" by Pfizer reaching peak annual sales of $1 billion) with Aposense’s novel molecule designed to improve its effectiveness within the tumor, along with a superior safety profile.
The ATT-11T mechanism of action is based on selective release of SN-38, the active metabolite of the drug, within cancer cells.
To date, ATT-11T efficacy has been demonstrated, in several pre-clinical studies which showed a clear advantage in tumor suppression of ATT-11T over Irinotecan. Furthermore, this advantage is augmented as the dose of both drugs is reduced.
Aposense intends to submit a pre Investigational New Drug Application (IND) and work with the FDA during the first half of 2014, to complete formal toxicology studies and initiate phase I/II clinical trials towards the end of 2014.