Dear Friends of Cortene,
We would like to update you on our progress.
Clinical supplies: Laboratory development and testing of the CT38 drug formulation were completed late-May allowing a path to submit our trial application for regulatory approval.
Protocol: The trial design involves 18 patients, subjected to 2 exercise stresses (on a stationary bicycle), each followed by a 4-week recovery period, and separated by treatment (2x 3-hour infusions of the sterile drug solution, at 1 of 3 dose-levels—low, intermediate or high).
Endpoints: The study will compare pre- and post-treatment differences, in exercise performance and function during recovery, using a combination of objective and subjective endpoints. Objectively, we will measure exercise performance (via blood gases, work, time to ventilatory threshold, etc), and function during recovery (via continuous Fitbit monitoring providing data on activity, sleep, heart rate, etc, and daily online cognitive tests). Subjectively, we will measure daily symptom scores (and narratives on unusual activity and effects).
Progress: The Clinical Site (BHC) has identified several good candidates for treatment, and an initial 5-6 patients are potentially ready to start the trial. BHC is also recruiting other patients for a non-interventional trial, and many of these patients will be eligible for our trial.
Regulatory Submissions: During the week of June 4th, we filed an investigational new drug application with the FDA. This brings together all the information on the theoretical basis for the treatment, the toxicology, chemistry/manufacturing and clinical safety of the drug, as well as the trial protocol. We also submitted to the Institutional Review Board (IRB, concerned with patient safety and rights). Assuming no FDA/IRB issues, we should be able to commence the trial in the first week of July.
Investment: We have welcomed a new investor into the seed round and this completes our fund-raising activities for the present.
Intellectual Property: Our patent formerly published (though this does not change anything). We have not yet started prosecution of the patent, which we will do as soon as we have some proof of effect (from the trial).
Blogs: As mentioned previously, Cort Johnson (renowned for simplifying the research for patients) published 3 blogs on Cortene, which generated enormous interest (actually the most successful blogs to date). We plan to publish a 4th blog, upon IRB approval, providing site/protocol details.
In sum, if all goes well, we hope to start the trial at the beginning of July, have the first patient exit by early October and ideally, complete the low dose-level by end of October.
We would like to thank our investors and advisors who have made this possible.