Bioshares has a Speculative Buy Class B recommendation for Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) after the company released positive trial results from its Phase Ib study in patients with T-cell lymphomas.
The results surpassed Prescient’s expectations from both safety and early efficacy perspectives, especially in the difficult-to-treat patient population.
The following is an extract from Bioshares’ investment note:
Oncology drug development firm Prescient Therapeutics (PTX: $0.071) has released positive trial results from its Phase Ib study in patients with T-cell lymphomas (relapsed and refractory) which were presented over the weekend at the ASH (American Society of Hematology) meeting in San Diego.
There were 19 patients in the study with r/r TCL with efficacy results available for evaluation from nine of those patients. The overall response rate was 44% (four from nine patients) with two partial responses and two with a complete response. An additional two patients had stable disease for more than six months giving an overall clinical benefit in 66% of patients (six of nine patients).
The study also recruited six patients with other cancers however no efficacy benefit was observed in those patients. Prescient had observed initial results in patients with r/r TCL which is why the study directed to focus on this disease type.
Whilst the results are very encouraging, the very good safety profile of the drug candidate, PTX-100, means the drug candidate can progress to combination treatments with other oncology therapies. The median progression-free survival (PFS) for the nine patients was 12.2 months, where between five to six months median PFS is considered the benchmark for new therapies.
Prescient may move to a registration study with PTX-100 mid next year, however it will first meet with the FDA early next year according to CEO Steve Yatomi-Clarke. The study may incorporate a 'lead-in' with around 40 patients with the study total possibly involving around 120 patients. The lead-in will provide information on whether the trial should continue to the full planned size.
For Prescient this is the first timed its studies have been presented at ASH. Moving into the Phase II study, and potentially a registration study for the orphan disease TCL, will be a major event for the company. The trial will likely be conducted in Melbourne, Sydney and the US.
PTX-100 works by inhibiting the Ras pathway in cancer cells, inactivating the three different cancer circuits Rac, Rho and Ral, which differentiates the compound from competition.
Prescient is capitalised at $57 million with $18.7 million at the end of September. It has since received an R&D tax rebate of $2.4 million.
Bioshares recommendation: Speculative Buy Class B