Pathogenes Inc.

Oroquin-10

FULL TECHNICAL SUPPORT FOR STUDY PARTICIPANTS USING OROQUIN-10 IS AVAILABLE @ 352-214-5209 begin_of_the_skype_highlighting            352-214-5209      end_of_the_skype_highlighting AT ANY TIME.  EMAIL SUPPORT IS AVAILABLE ON THE CONTACT US TAB.

Oroquin-10 is a combination of drugs that can be used in a strategy to identify clinical EPM and is being used in a clinical trial to fulfull the requirements of an FDA new drug application.  This drug is only available to veterinarians participating in the trial.

Antibody titers to SAG 1, 5, and 6 at treatment iniation and four to six weeks after the 10 day Oroquin-10 therapy are required.

Veterinarians can request the sign-up process by email request located on the Contact Us tab.

Veterinarians that have experience identifying and treating a horse with EPM and would like to participate in the Phase II trial and/or participate in a contact list for other veterinarians please let us know by filling out the submission form.

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Preliminary Efficacy Field Clinical Trial

Participants  Finished   Success     No change    AE 

     362              240           221              19            74

Cross over Field Study for chronic EPM

      22               18             18                     Marquis

      16               12             12                     diclazuril

       8                 4               4                pyrimeth/sulfa

The cross over trial enrolls horses that have not responded to the indicated treatment.  This is an observational trial.  Trial participants that did not respond to the indicated treatments, Marquis, diclazuril (or Protazil if used) or pyrimeth/sulfa are then treated with Oroquin-10.  The same assessments are used for this trial and the Field Clinical Trial.

Oroquin-10 Field Trial

Oroquin-10 will be used in a target animal field trial to obtain efficacy data. 

This clinical trial will use field veterinarians as investigators.  Each investigator will determine a diagnosis of EPM based on clinical neurological exam and serum antibodies against SAG 1, 5, and 6.  The diagnosis will be confirmed by response to anti-protozoal drugs determined by neurolgical exam conducted by the investigator.  The response to treatment evaluated by clinical neurological exam by the same investigator and second serum antibody evalulation is required.  If present, the diagnosis of allergic encephalitis will be documented as well as appropriate treatment recomendations.

Any untreated animal with a presumptive diagnosis of EPM will be admitted into the trial.  A treatment success will be based on clinical exam, improvement 60-100% and a reduction in serum antibodies.  A treatment failure will be designated by no improvement in clinical signs, irrespective of serum antibody levels.

The treatment protocol can identify animals that may have allergic encephalitis (AE).  We offer a strategy to alleviate the signs of AE on an individual basis as well as providing information to determine the best course of action for each animals rehabilitation.

Int J App Res Vet Med 10:1 2012

Decoquinate combined with levamisole reduce the clinical signs and serum SAG 1, 5, 6 antibodies in horses with suspected equine protozoal myeloencephalitis

Siobhan Ellison and David Lindsay

link to the article

 The Path To FDA Approval

We have a determination that our intended use constitutes a “minor use” that entitles us to a waiver of user fees and will allow us to qualify for incentives to facilitate a New Animal Drug Application (NADA) approval.  The first hurdle, opening an investigationa new animal drug file is complete.Our next  step is submission of the efficacy data and production of Oroquin-10 containing the investigational use label. The requirements for the sections of the NADA are on line at their web page. 

To participate in the field trial to obtain efficacy data for the full license application fill out the EPM submission form under the services tab and send it vial email or mail to us.  After you sign up you will get a packet of information on the requirements.  The big chores are documenting the location of the investigator, date, amount, and some particulars about the manufactured batch and the most important part, how the animal responded.

An NADA containing unreviewed data takes CVM 6 mos to review.  If the technical sections are all complete, an “administrative NADA” only takes 60 days.  Our target is the administrative NADA.