Phase II case-control trial initiated for four types of terminal cancers

Reviewed by James Ives, M.Psych. (Editor)Jan 7 2020

The Alexandrov National Cancer Centre begins phase II case-control clinical trial of its immuno-oncology agent, Elenagen.

Inoperable late-stage cancer patients with triple-negative breast cancer, ovarian cancer, stomach cancer or prostate cancer will be randomized and then subsequently receive either standard chemotherapy or chemotherapy combined with Elenagen.

For each disease, the experimental and control groups will be compared for time to disease progression, overall survival, as well as tumor regression and the dynamics of clinical conditions. One can also expect a reversal of a tumor grade to an operable stage, which would make the tumor surgically removable.

We have conducted a comprehensive worldwide search for the most promising adjuvants to standards of care and selected Elenagen.

We assessed hundreds of potential products according to the following criteria: high safety as demonstrated in phase I/IIa clinical trial, encouraging first signs of synergistic effects with chemo-, radio- and immunotherapies, the economic feasibility of the future product and its accessibility for the healthcare system, and scientific novelty. Elenagen satisfied all of these criteria".

Oleg Sukonko MD, Ph.D., D.Sc., Professor and Head of the Alexandrov National Cancer Centre

Elenagen was developed by, CureLab Oncology, Inc., a Boston-based biotech startup which provided the product to Belarussian colleagues. Aldevron, Inc. (Fargo, ND) was the contract manufacturer for the product.

"Although in the coming year we are planning to start phase II clinical trials of Elenagen in breast and ovarian cancers in the US and multiple other countries, it was very important for us to begin with Belarus, the country which was the most hit by Chernobyl", said Dr. Alex Shneider, CEO of CureLab Oncology.

"We are very thankful to our colleagues from NYU and MD Andersen Cancer Centers who donated their ideas and expertise, went with us through multiple iterations of the clinical protocol, and helped to create the final version which we will now implement in our studies. Without their generous assistance and continuous expert support, we would not be where we are now", said prof. Sergey Krasny MD, Ph.D., D.Sc., deputy director of the Alexandrov National Cancer Centre and corresponding member of the Belarus National Academy of Science.

The study is unanimously approved by the Belarus Ministry of Health. The team of clinical scientists conducting the trial in Belarus will maintain constant contact and consistently exchange information with their colleagues in the US, EU, and Israel serving as observers and scientific co-authors to the study.