Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) earlier this week secured orphan drug designation in Europe for its lead candidate PTX-100, a treatment for cutaneous T-cell lymphoma.
The company said the designation provides ten years of data exclusivity following approval and allows for direct discussions with the European Medicines Agency regarding study design. It highlighted that this development was both commercially beneficial and important for enhancing the company’s attractiveness to potential partners.
Prescient told investors that the designation meets a significant unmet need, particularly for patients in Europe who have fewer treatment options than those in the United States.
CEO James McDonnell said the designation was a meaningful step forward for the PTX-100 program and noted that it “provides choices” both clinically and commercially.
The company will host a live and online investor webinar on Tuesday, November 25th at 3:00 PM AEDT. The session will provide further insight into what the orphan drug status means for the PTX-100 program and the progress of its Phase II clinical development.
Prescient encouraged shareholders and interested parties to access registration details via its most recent press release.
Proactive:
Prescient Therapeutics has secured orphan drug designation in Europe for its lead drug, PTX-100, targeting cutaneous T-cell lymphoma. All the details are with the company's CEO, James McDonnell. James, it's good to see you again after quite some time. How are you?
James McDonnell:
Yeah, very good, thanks. A busy day. Getting on with the day.
Proactive:
James, it's quite an announcement, to say the least. Investors are full of rejoice — your share price is up nearly 19% at the time of this recording. There are a couple of things I want to address the market with today, but let's first focus on how this will benefit thousands of cancer patients across Europe. Walk us through what it really means for those cancer sufferers in Europe.
James McDonnell:
Well, patients in Europe with CTCL have fewer options than they do in the US, and there's clear unmet need there. So this is an opportunity to provide another option for them. So they should be pretty happy.
Proactive:
And James, this designation will unlock many benefits for Prescient as a company overall I believe, yes?
James McDonnell:
It does. I mean, it provides ten years' data exclusivity after we have an approval in Europe, which is commercially very helpful. It allows us to talk to the European Medicines Agency about the study designs, this phase reductions. So commercially it’s good. It’s also really helpful from a partner attractiveness situation — it provides choices.
Proactive:
James, you will be holding a live and online investor briefing on Tuesday, November 25th, in which you will address the market. How can people register for this webinar, and what will you be discussing?
James McDonnell:
People can log on to the press release and see there’s a link to the actual webinar on Tuesday the 25th at 3 p.m., Australian Eastern Time. Really discussing the orphan drug designation and what it means in the context of the whole PTX-100 program. And talking a bit about the study as we progress through our Phase II and beyond. So yeah, it would be a nice update. It’s always good to speak to investors and take Q&A for sure.
Proactive:
And hopefully there’ll be a massive turnout next week. Thank you so much for this update. This was Prescient Therapeutics CEO James McDonnell. We appreciate your time.
James McDonnell:
Thanks, appreciate it.