Charles Ryan: Hello, I’m joined today by Dr. Pamela Munster. Dr. Munster is a researcher on breast cancer and the hereditary genetics of breast cancer, but also an entrepreneur in the area of prostate cancer. She’s developing a device, for the treatment of early-stage prostate cancer.

Thank you for joining us, and let’s talk a little bit about your device, and what it does, and where it’s going.

Pamela Munster: In order to give you a little bit where it’s going, I need to give you a little bit of background, why we actually felt so strongly about this.

So, as you know, I’m in charge of Phase 1 development at UCSF, and with this, we develop novel agents and strategy for the treatment of advanced metastatic cancer. Unfortunately, the way we developed drug, that makes it actually very, very difficult to take any such drug for prevention. And as you know, from a development standpoint, is like, making prevention drugs have been exceedingly difficult, partly because we don’t really know who’s at risk, the side effects are often prohibitive. And the signal-to-noise ratio is very difficult.

So, we wanted to take an approach that is bit mundane, if you will. We felt like if we wanted to go into prevention, we needed to have a drug that already has a track record, does it work? We needed to have materials that we can deliver a drug locally, just to the prostate, and not mess with the testosterone, but occupy the receptor in the prostate directly.

And then, we also wanted to have something… An approach that is feasible, right? And easy. So, we designed this device, that is a silicone based device, and we put in anti-androgen, and right now, we’re working with bicalutamide. And then, we implant this into the prostate, with the goal that it delivers hormonal therapy for at least two years.

And right now, we actually have done the dog studies, we’re hoping we’re going to be in patients in a year. And really, with a goal to develop a new strategy to deliver drug only to the prostate. Not systemically to decrease the withdrawal of hormones, which I can’t offer the charge as a woman, but from what I hear, is not very pleasant to have your testosterone suppressed.

Charles Ryan: That’s a topic for another day. But, let’s… So, the patients who you would treat with this would be individuals who are otherwise considering active surveillance, they’ve been diagnosed with prostate cancer. So, it’s not really, is it… Do we want to call it primary prevention? Or secondary prevention? Or is it early treatment?

Pamela Munster: I think it’s an early interception, if you will, because I think the emerging data in prostate cancer, is a bit like in breast cancer, like, many women will never die from their breast cancer, we just don’t know whose tumor is going to recur, and whose tumor going to be problematic. And I think the same in prostate cancer, if you look at PIVOT trial and ProtecT, and the Swedish trial, there’re clearly men who benefit from an intervention. But the majority of men don’t.

We train to really find an option for the younger men, who are not comfy with their active surveillance, but really don’t want to do prostatectomy or radiation, and hope that we can delay prostatectomy.

Charles Ryan: And you know, there have been preventions studies, using dutasteride, and finasteride in the setting. And those drugs actually have a lot of systemic side effects. So, you’re, I think, very much going after a target that is desired, which is to have the local hormonal effect, without the systemic effect. And that would be really a significant advance in the management for these patients.

So, I agree. Many of them, while they may have a good prognosis, in the short-run, if you’re 51, and you’re told to go on active surveillance, there’s a pretty good chance that over time, you’re either going to need treatment, or you’re going to need a lot of biopsies over time.

So, it’s really interesting, and so, we look forward to hearing, maybe in a future year, some of the early phase trials on that, and thank you so much for joining us.

Pamela Munster: My pleasure. Thanks for giving me the opportunity to talk about something that’s dear to my heart now.