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First in Class Potent Anti-cancer Akt Inhibitor:
ArchexinTM is a first-in-class, potent inhibitor of the Akt-1 protein kinase in cancer cells. ArchexinTM is in Phase II trials for treatment of renal cell carcinoma (RCC) and pancreatic cancer, and has US FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. ArchexinTM is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and highly selective for inhibiting mRNA expression and production of Akt protein. Akt activation leads to cancer cell survival, proliferation, and angiogenesis. Both native and activated forms of Akt are involved in cancer cell signaling. Activated Akt also play a role as a drug resistance mechanism, in particular, of targeted therapies.
ArchexinTM is the first anticancer drug that inhibits both forms of Akt, with the potential to inhibit cancer survival and proliferation, angiogenesis and drug resistance. In the ArchexinTM Phase I clinical study, grade 3 (G3) fatigue was the only dose limiting toxicity observed. No significant hematological effects or other adverse events were observed.
The ArchexinTM Phase II study goals are to assess efficacy and safety in treating advanced RCC and pancreatic cancer. The primary study endpoint is objective tumor response. Other endpoints include survival (PFS, OS), biomarkers, and quality of life measures. We will conduct clinical trials concurrently and globally to expand indications.
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