Our most advanced drug candidate is Cordycepin, which is one of the best medicinal (fungi) mushrooms, known for numerous positive aspects in terms of pharmacological effects and considered to be safe. The main constituent of the extract derived from this fungus comprises a novel bio-metabolite called as Cordycepin (3′-deoxyadenosine), which has potent anticancer activities.
We are developing Cordycepin as a treatment option for certain leukemia patients that are either refractory to currently used chemotherapeutics or have experienced a relapse.
Current Status: Clinical Trials
Cordycepin has been granted orphan drug designation from the US Food and Drug Administration (“FDA”) which allows for smaller clinical trial sizes, shorter clinical trial times, and higher rates of regulatory success. The potential annual revenue for this product is 400 million.
Cordycepin has been studied in a National Cancer Institute-sponsored Phase I clinical trial in 14 acute lymphocytic leukemia (ALL) patients. Furthermore, Cordycepin was studied in Phase I/II trial. The trial was conducted at two U.S. centers, The Dana Farber Cancer Institute in Boston, Massachusetts, and the Cancer Therapy Research Center at the University of Texas Health Sciences Center at San Antonio, Texas. The trial was designed to enroll up to 24 patients in the first stage and up to 20 patients in the second stage. After enrolling five patients, the study was placed on administrative hold by the previous development company to raise additional capital. In the patients treated in the clinical trials, no Cordycepin-related adverse events were reported. Biological activity in three patients was noted by the transient clearing of peripheral blood blasts.
Pre-clinical data and the preliminary clinical data for Cordycepin support the re-initiation of the Phase I/II trial in TdT-positive refractory leukemia patients. Rainforest plans to re-activate the Cordycepin IND in Q4 2016 and start the Phase I/II clinical trial in Q3 2017.