Shares in Australian pharmaceutical company Race Oncology Ltd (ASX: RAC) are up 4% from the open to now trade at $3.41 apiece. This follows an intraday high of $3.52.
Race Oncology shares are on the move despite there being no market-sensitive for the company today.
However, they are gaining ground amid a key update regarding a clinical trial submission the company announced today which is worth exploring at greater length.
Here are the details.
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Race submits application to start phase 2 trial
The company advised that it has submitted the "first human ethics application to the Hunter New England Human Research Ethics Committee" for approval to commence a phase 2 trial with its drug candidate Zantrene.
Specifically, the application is to commence an open-label phase 2 clinical trial investigating Zantrene in two complex disease segments, Extramedullary Acute Myeloid Leukaemia (AML) and Myelodysplastic Syndromes (MDS).
The former occurs when leukaemia spreads from the bone marrow and forms solid tumours in areas such as the skin, breast, kidney, or brain, etc.
The latter, MDS, is a category of blood cancers that affects the production of blood cells in bone marrow. Around a third of all patients with MDS diagnoses progress to develop AML, according to the company.
Being a phase 2 clinical trial, it will primarily examine the overall effectiveness and safety of Zantrene in patients with these conditions.
What does the trial look like?
The study, which Race labelled BISECT, will recruit up to 60 patients, separated into two 'stratum' or population groups.
Group 1 will receive a higher dose of Zantrene as a single treatment over 7 days with follow up cycles thereafter. The cohort will comprise patients with AML who can tolerate high-intensity chemotherapy.
The second group will receive Zantrene as a combination therapy, albeit at a lower dose, for patients who are unable to tolerate high-intensity chemo.
The trial is expected to take around 36 to 40 months to complete.
The application builds on previous studies indicating a potential therapeutic response in AML in combination with another drug, using mouse studies.
An important point for investors to note is that the trial "supports the use of orphan drug registration under the FDA 505(b)(2) pathway".
The 502(b)(2) pathway in the US enables drug manufacturers to obtain Federal Drug Administration (FDA) approval without having to compile the mammoth amount of data that's normally required with a new drug application (NDA).
If successful, this would remove much red tape for Race Oncology before commercialising Zantrene in the US.
What did management say?
Speaking on the announcement, Race Oncology's CEO Phillip Lynch said:
This study supports our Pillar 3 registration ambition to see Zantrene's historical safety and efficacy in AML demonstrated with superior drug combinations that may benefit patients who remain challenged by initial treatment failures. It is pleasing to be able to open up this trial to MDS patients who are equally in need of new improved treatment options.
Race Oncology share price snapshot
Race Oncology share price has climbed over 249% in the past 12 months after rallying 95% in the green since January 1.
That's well ahead of the benchmark S&P/ASX 200 Index (ASX: XJO)'s return of about 25% in the past year.
