Biomed company Aposense Ltd. (TASE: APOS) has successfully completed preclinical studies for the ATT-11T molecule for early stage treatment of colon cancer. The company said it has also completed development of an IV formula suitable for humans.
The ATT-11T molecule is now being developed by Aposense under an agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) , and is based on a combination of Irinotecan (marketed as "Camptosar" by Pfizer with annual sales of $1 billion) and Aposense’s novel molecule designed to improve its effectiveness within the tumor, along with a better safety profile.
In June, 2013, the company received approval to register a US patent to protect ATT-11T.
Aposense will submit a pre Investigational New Drug Application (IND) and work with the US Food and Drug Administration (FDA) during the first half of 2014, to complete formal toxicology studies and initiate Phase I/II clinical trials towards the end of 2014.
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. This advantage is augmented as the dose of both drugs is reduced.
Aposense CEO Dr. Miri Ben-Ami 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."
Published by Globes [online], Israel business news - www.globes-online.com - on January 9, 2014
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