Author: Cortene

Dear Friends of Cortene,

We know you’re excited to hear the results of our trial and we will get to that later in this newsletter.  First, we want to acknowledge all of the ME/CFS sufferers and their family members who have written in interest and provided their support.  You are the reason we continue to work diligently towards finding a treatment for this disease.

Second, we want to apologize that our mailing list has grown to the extent that we can no longer afford the time to reply to everyone’s emails personally.  That said, please know that we read them all and hope this newsletter contains the answers you’re seeking.  For questions not answered here we will also be adding an FAQ to our website, so keep them coming.

With the help of Dr. Lucinda Bateman at the Bateman Horne Center, our InTiME trial tested 2-3 subcutaneous infusions of CT38 at 4 different dose-levels in 14 ME/CFS patients.  While the trial was completed in April 2019, the publication of results has been delayed due to novel findings that necessitated the filing of a new patent.  This should be filed this month and our next objective will be publication.  This is in process but will also take some time while the draft article is peer-reviewed and edited.  The publication process could take about 6 months from the time we submit to a journal.

While we would love to share the details of our findings that would likely affect our ability to have those results formally published by a reputable journal.  We do appreciate your patience but suffice it to say, the results were interesting enough that we will be pursuing another larger placebo-controlled phase 2 trial.  That process will begin as soon as we have the funds.  We need to raise at least $5M, though $12M will allow us to work in parallel such that (if the phase 2 trial is successful) we will be able to proceed immediately to a phase 3 trial as required for FDA approval.

Many people have asked when our drug might be available.  Answering that is difficult because not only does it depend on having positive findings in each trial, it also requires access to funding.   We will go out on a limb and say that the best case scenario for FDA approval is about 4 years from the time we secure funding.  We know that is a long time to wait but it is important that we ensure this treatment is both effective and safe before making it widely available to patients.

Thank you to the many patients who have offered to participate in our trials.  Please know that the process of recruiting and screening patients is not one that Cortene controls.  For good reasons, this responsibility belongs to the doctors providing the treatment.  While we have not determined which doctor(s) will be investigating our next trial, we will make that information available when the time comes.  For our international audience, unfortunately we don’t have the funds to pursue international trials at this time.

We truly appreciate your continued support and wish each and everyone one of you a happy and very healthy new year in 2020.

Warmest Regards from,

The Cortene Team

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.

Trial Specifics

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.