(ASX:RCE) has announced that a Special Access Scheme (SAS) Category A notification has been made to the TGA by a medical practitioner following the successful treatment of a patient with RECCE 327 (R327).
The company, which is developing new classes of synthetic anti-infectives, said R327 is administered via nasal passage against multidrug-resistant pseudomonas aeruginosa (P. aeruginosa) sinusitis infection.
“While the Company is pleased with the apparent success of the application of R327, it is important to note that only a single patient has been treated pursuant to the Special Access Scheme, which is a notification pathway which can be accessed by health practitioners on behalf of a prescribing medical practitioner for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment, and does not constitute a clinical trial,” said the company.
It added R327 is not approved for use in humans and significant further clinical testing is required to evaluate its quality, safety and efficacy.
The company said it was encouraged by the outcome.
It said, “A 59-year-old male was categorised as suffering multidrug-resistant P. aeruginosa sinusitis infection. Clinical samples of R327 were released under strict medical oversight having been determined to meet TGA SAS-A criteria, including: ‘seriously ill, where death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.'”
It continued, “Patient X (for reasons of patient confidentiality) dosed according to a strict, dose-escalating protocol applying 5 -10 drops per 20 millilitres of R327 in saline solution, three times a day into the infected area. Using a rubber bulb, Patient X pushed the mixture up into both the left and right nasal passages, toward the ears. Upon applying R327 in the infected area, Patient X noted a minor stinging sensation as the solution reached the area of infection in both nasal passages, subsiding after approximately three minutes.
“Within 90 minutes, Patient X recorded their sinuses began to feel clearer, less inflamed and reported less discharge. As Patient X continued their dosing program, it was recorded the stinging sensation subsided over time. Over a three-day period of applying R327 topically via spray to the infected areas in the sinus’, Patient X reported a substantial reduction in infected discharge, termination of sweating and a return to normal sleeping patterns with no side effects. Post-dosing program, blood samples were taken and tested. These samples showed no detectable signs of P. aeruginosa infection and no abnormalities.”
The company said it is encouraged by the nasally administrated response of this patient and the formal submission to the TGA of the Special Access Scheme treatment, following its completion.
According to CEO James Graham, “We are thrilled by this positive indication for this patient with a terribly, debilitating condition that has been driven over many years by this recalcitrant pathogen.”