Osborne Park-based Solbec Pharmaceuticals Ltd has had a small win, with the United States Food and Drug Administration allowing the use of its Coramsine cancer treatment under a Physician's Investigational New Drug application.
The practice, similar to a compassionate use application under the Australian Therapeutic Goods Administration's Special Access Scheme, will allow one doctor to prescribe the medication to a patient after proving that the treatment had been effective.
The full text of a company announcement is pasted below
Perth, Australia. 16 October 2007: The Company (ASX: SBP) is pleased to announce that it has received notice from the United States Food and Drug Administration (FDA) for a single use treatment with Coramsine® for a U.S. patient with advanced renal cell carcinoma. The patient received their first dose of Coramsine® overnight (midday U.S. Pacific time).
The Sponsor of the single patient application is Dr Robert Nagourney of Rational Therapeutics (www.rationaltherapeutics.com) in Long Beach California. Rational Therapeutics (RT) and Solbec have had a working relationship with each other for the last several years. Specifically, in December 2004, Solbec commissioned RT to screen Coramsine's® anti-cancer activity against up to 72 human tumour samples via ex-vivo
analysis. In addition to this work Solbec have continued to provide Coramsine compound to Dr Nagourney at RT for their ongoing cancer screening program. Ex-vivo Analysis is used to identify the chemotherapy drugs that will work most effectively for an individual's specific cancer and hence the screening process involves real tumours not cancer cell lines.
The Physician's IND is being made on the basis that the specific patient's tumour has shown ex-vivo sensitivity to Coramsine where other conventional chemotherapeutics have failed.
"We are very pleased to be invited by Dr Nagourney to assist in this patient's treatment. The patient's tumour type (renal cell carcinoma) fits in with the results we saw in the Australian Phase I trials where we saw a patient with end stage RCC respond to the Coramsine® therapy. That patient remains in remission to this day." David Sparling, Solbec's General Manager.
A Physician's Investigational New Drug application (Physician's IND) is similar to a compassionate use application under the Australian Therapeutic Goods Administration's Special Access Scheme. Please note: this application does not equate to a full IND filing.
