Pathogenes has many partners in our quest to bring a safe equine therapy to market. We have scientific partners, financial partners, veterinary partners, horse owners, and the government. The government is everyone's partner in business. In return for income tax the FED provides infrastructure and many other services that fly under the radar.
Our partnership with the FED’s will allow us to bring two drugs to the equine community. In return for their services we provide a percent of fees for the life of the commercialized product. As part of the drug licensing process the center for veterinary medicine provides milestone goals and a path to complete those goals. Our path is directed by guidance information documents, GFI’s. As we accomplish each goal, we take the next step.
Our first milestone was developing a treatment and providing information to FDA that equine protozoal myeloencephalitis (EPM) is an important, rare disease. Unprofitable for big pharmaceutical companies to develop the treatment of EPM falls under the (orphan) drug act, or MUMS. Pathogenes commitment is to provide a safe and effective therapy that all can afford and its designation under MUMS makes that possible. The MUMS program provides help with submissions, fee waivers, and guidance so we can accomplish our goals. the FDA has a big say in the studies that we run to meet milestones that lead to commercialization.
Starting the next field trial with NeuroQuel is a milestone. Before we could move forward with our therapies we had to produce a drug that had rigorous scrutiny in the manufacturing process. Unlike compounding (one- drug one-animal, no quality control for the drug substance activity/stability in the product) an FDA licensed drug must be carefully evaluated--that means nearly a million dollars is associated with production. A drug manufactured in a facility compliant with cGMP’s is licensed because it has achieved the rigors of ingredient and production testing.
A next step is the NeuroQuel PLACEBO CONTROLLED FIELD TRIAL. There seems to be misinformation about placebo controlled trials so here are some facts to clear the air:
- You must enroll to be considered for a placebo controlled trial. You must sign a paper informing you of the nature of the study and by enrolling you agree that you understand the conditions of the study.
- Enrollment documents explain the statistical chances that you will receive a placebo or the active drug. If you haven’t signed an enrollment document, you are not in a placebo controlled trial!
- Enrollment requires that information is given back to the study monitor! If you have not completed in-trial and end of trial forms you are not in a placebo controlled study.
- A horse enrolled in the study must satisfy some entrance criteria. Entrance criteria can include age, weight, and recent treatment history. A huge entrance factor in our placebo controlled study is diagnosis of EPM.
The up-side of these controlled studies is the quality of the information that is given to FDA. The down side may be the number of forms that have to be signed! We spent the last couple of years training veterinarians about EPM. We gave our trained veterinarians continuing education for their help and attention. Most discovered some new things about their EPM case, veterinarians didn’t learn everything they needed to understand EPM in veterinary school! Most importantly, we found diseases that mimic EPM. We spent a few years developing tests to identify EPM-mimicking disease so that our study isn’t compromised. The recognition of these EPM-mimicking diseases did lead to publications that educated those veterinarians that are current with EPM topics. Effective treatment of some of these horses (that didn’t respond to commercialized EPM therapies because they didn’t have EPM) became possible.
We are contacting our trained veterinarians that treat horses with EPM so they may enroll horses that have failed on commercial EPM treatments. NeuroQuel is for the treatment of horses with residual or relapsing signs due to EPM caused by S. neurona. Horses eligible for enrollment in the placebo controlled NeuroQuel study include a diagnosis of EPM with a cerebrospinal fluid analysis (CSF test) followed by treatment with the label dose of a licensed antiprotozoal therapy (no compounded products or off label drugs) within 90 days of enrollment. Other conditions include age and the degree of deficit. If you have a horse that was diagnosed with EPM by CSF tap, has not completely responded to Marquis, Protozil, or ReBalance using the dose on the label and has residual signs you may have a case that will qualify for our study.
For full information on the enrollment of horses into the placebo controlled field study please check out the downloadable documents at http://pathogenes.com/w/clinical-trial/. Or use the contact information at www.pathogenes.com and we can help with the enrollment process. Enrollment in these studies will help bring our treatment to market and bring new information to the equine community.
If you have a horse that does not qualify, please give us a call. It is important to document the reason the animal couldn’t participate.
For more information about placebos and the “placebo effect” please consider http://www.wired.com/2009/08/ff-placebo-effect/