Prescient trials show total eradication of cancer
Shares in Prescient Therapeutics Limited (ASX:PTX) surged 50% on Wednesday after the clinical stage oncology company developing personalised medicine approaches to cancer released promising news in relation to its Phase 1b study in patients with acute myeloid leukemia (AML) who are being treated with PTX-200.
Management said that it planned to expand the phase 1b study following an encouraging third complete response which represents total eradication of disease.
The company’s shares have more than doubled in the last fortnight after receiving a significant boost on November 14 when management announced that the first patient had been treated with the group’s anti-cancer drug PTX-100 in a phase 1b trial enrolling patients with multiple cancer types.
From a broader perspective, unlike many other smaller biotech companies, Prescient has a track record of delivering on its promises as outlined below.
PTX-200 is a game changer
While achieving these optimum levels of operational efficiencies are attracting investors to the company, it was yesterday’s news that really had a profound impact with the share price rerating occurring under all-time record trading volumes.
Three of a total of 15 patients experienced complete responses in the study in relapsed or refractory AML patients, which is a difficult to treat cancer population.
The three patients had between 25-35mg/m2 PTX-200, together with 200-400mg/m2 cytarabine.
PTX-200 is a novel PH domain inhibitor that inhibits an important tumor survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia.
Unlike other drug candidates that target Akt inhibition which are non-specific kinase inhibitors that have toxicity problems, PTX-200 has a novel mechanism of action that specifically inhibits Akt whilst being comparatively safer.
In consultation with the study investigators, Prescient is making a protocol amendment to change the dosing schedule of PTX-200 in relation to the administration of chemotherapy agent cytarabine with the aim of minimizing overlapping drug interactions.
In a previous Phase 1b study in acute leukemias using PTX-200 as a single agent no such side effects were observed, suggesting that the effects seen in the current study may be due to the overlapping interaction of cytarabine and PTX-200.
Enrolment re-start in 2020
Generally, most patients receiving treatment on the study by group have tolerated planned dose levels.
Transaminase elevation was observed in three patients, although only one was dose limiting.
The amendment will go through usual FDA and ethics committee reviews and the study should be able to re-start enrolment in early 2020.
Prescient’s chief medical officer, Dr Terrence Chew said, “The three complete responses observed are very encouraging in a hard to treat patient population.
‘’Through this protocol amendment, we aim to get more patients through more cycles of therapy, with the hope of expanding upon these responses.
‘’Our investigators are very supportive of these amendments, as they are encouraged by these results in a patient population that is very difficult to treat and who currently have few treatment options.”
The study is led by world-renowned leukemia expert Professor Jeffrey Lancet at the H. Lee Moffitt Cancer Center in Florida, and also includes Kansas University Medical Center and Yale Cancer Center.
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