We at ISSAR, are translating decades of research, innovation and development into perspective therapeutics for the second leading cause of death worldwide: CANCER
Cancer occurs due to abnormal, rapid and uncontrollable growth of cells invading different parts of the body. Cancer accounts for the second leading cause of deaths worldwide after cardiovascular disease. The number of deaths due to cancer is predicted to exceed 13 million by the year 2030.
As a result of technological advancement in early detection and treatment of the condition, the survival rate for most common cancers has risen up from 43% to 64% in men and 57%-64% in women.
Composition and mechanism of action
IS 107 is a peptide that kills cells through a mechanism involving permeabilization of plasma membrane and entry of peptides into the cell, causing necrosis & apoptosis.
Preclinical and clinical trials
• In-vitro screening of the peptide Genopep 1 (ISSAR–1) with 20 cancer cell lines was made using Adriamycin as a positive control taking 10-4 to 10-7 molar solutions and / or 5 to 40 µg/ml concentrations. Ten of these cell lines were inhibited more with peptide Genopep 1 than the positive control Adriamycin.
• In-vivo efficacy testing of Genoepep-1 (ISSAR–1) was done with HCT-15 Xenografts tumor bearing nude mice by injecting the peptide into the opposite side flank of tumor. These studies led us to believe that 50.12 mg/kg in mice was the most efficient dose.
• In-vivo efficacy testing of Genoepep-1 (ISSAR–1) was done with HCT-15 Xenografts in nude mice by simultaneously injecting the Xenografts HCT-15 on one side flank of the animal and peptide into the other side of the animal to know the inhibition of the tumor development and metastasis inhibition.
Good inhibition of tumor development was observed with 50.12 and 0.1253 mg/kg. However, 1/40 of this i.e.0.1253 mg/kg was also equally efficient.
• Phase 1 clinical trial: A phase 1 open label, non-randomized, multi-arm, multi-center, parallel sequence study to determine the maximum tolerated dose and the dose limiting toxicity of genopep 1 (ISSAR 1) in relapsed solid tumor cancer subjects was done. PROTOCOL NO.: ISSAR/2007/01
Overall, 79 subjects were enrolled in the study out of which 74 subjects were considered for this analysis. The different types of cancers studied were:
Phase – I studies are meant for safety. According to the Phase–I clinical data, the type of cancers screened are mostly carcinomas and few sarcomas, Phase –II studies are yet to be conducted to identify the carcinomas and sarcomas in which the cancer drug is efficacious and safe.