Interview Transcript- Part 3 of 3
Nelson Vergel: And could we go real quick on describing what the numbers below mean? Is that …?
Dr Ramasamy: Sure. Basically, the number of patients above 300. We wanted to see the number of patients that were brought from the baseline levels of less than 300 to the percentage of patients that ended up having a normality level. That’s what the percentages mean. And on the blue bars are basically the average testosterone levels that were reached. Obviously, at six months, it’s only five patients at six months that have completed it. We have more data now. We’ll update this, but we could tell that most of them ended up having levels in the 600 rate under range at the six-month time point.
Nelson Vergel: Were you able to measure quality of life like ADAM questionnaire or something, sexual drive? How do you guys feel at …? Should I move on with the presentation?
Dr Ramasamy: Yeah, you can. But no, so absolutely. We’re not using the ADAM questionnaire, but were using the IIEF questionnaire to measure sexual life and sexual activity. And I can tell you most of these young guys are already fairly sexually active, so they not necessarily have erectile dysfunction. But we’re also measuring quality of life with the SF36 questionnaire, which is a validated questionnaire because we can actually measure if there are changes in quality of life. And I don’t know, I think we have data on the three-month time point. I’ll go back and look because they started off very well in the beginning. Most of these guys were very happy. Their questionnaires didn’t change much. But I can tell you from just talking to patients, they’re all fairly very happy.
Dr Ramasamy: Again, very surprising because I never prescribed this medicine. And I didn’t think this was going to work. And I told myself, “I’m never gonna give this.” And I didn’t think men would be willing to stay on the medicine, would be willing to take the medicine, would be willing to put something up their nose three times a day. But I have to tell you, Nelson, I’m fairly surprised with the number of patients that want to get on the trial and want to stay on the trial enough that after they finish the trial, we provide a coupon called through a specialty pharmacy. And most of them, as long as they have good insurance companies, they pay $10.00 a month, copay for this. I’m surprised. I’m still surprised.
Nelson Vergel: Well, good. Hey, so am I. So am I.
Dr Ramasamy: This is the semen parameters data, so let me explain this a little bit. On the first three red bars are the sperm concentration. The concentration is a million sperm per CC. The red bar shows that at baseline, they started off with 20 million. If you truly look at men who take injections or pellets, their concentrations at three months and six months should be almost zero. Like we said, two-thirds of the men should have zero sperm count at the end of three months if you take testosterone cypionate. This was fairly shocking and surprising, and obviously in a good way that their sperm concentrations are actually maintained both at three months and at six months.
Dr Ramasamy: And the green bars represent percentage in motility, meaning the number of sperm that are moving, our percentage of sperm that are moving. At baseline, when you look at the first green bar, the percentage of sperm that was moving, that was about 50%. And then when you look at the motility at three months and six months, there are no differences between these three things, and the motility is also maintained. And interestingly, TMSC is the total Motile sperm count, it’s basically a multiplication of concentration motility times the semen volume, and that is also maintained between three months and six months.
Dr Ramasamy: So this is the first study that has actually shown, and this is the only trial that is being done in the US now, showing that sperm parameters are actually maintained on exogenous testosterone therapy. People have shown it with clomiphene citrate, with anastrozole, with HCG, and Dr. Lipshultz has shown it when men use testosterone cypionate in combination with HCG. But this the first one to show, just by testosterone alone, that you are able to maintain semen parameters.
Dr Ramasamy: This is the study results so far, 23 patients out of 40 have been recruited, eight have completed the three-month time point, five have completed the six-month time point, and six patients have dropped out of the study. One patient, their reproductive endocrinologist, the wife’s doctor told them they have to stop, “this is testosterone therapy. Which doctor put you on this? You know you’re sperm count is going to become zero, this is crazy,” and so he stopped it. Another patient stopped, a couple of patients, actually, stopped because of the rhinitis, cause it was allergy season and they couldn’t take the nasal spray along with the gel, and so he had to drop out. And two of them could not come to follow-up appointments because the study was just so rigorous, we needed to get two testosterone levels at the three-month visit, along with semen analysis, and the same thing to be done at six months as well. So they just couldn’t make it up to the follow-up appointments. So six have dropped out. This did not belong to the 23, 23 patients have actually completed the study, but this is outside of the trial numbers from the 23.
Nelson Vergel: Yeah, I used the product and I liked that rush afterwards, especially going to the gym. But I did tend to have headaches, and obviously my blood pressure, which is always [inaudible 00:31:58]. And sinus stuffiness, and that’s really, it bothered me the most, the sinus stuff, but you feel it, so anyways, let’s move on.
Dr Ramasamy: I mean, listen, Nelson, I think it’ll be nice, and I was talking to one of the other patients that day. I think if we can get some sort of a, you know how you use, like daily Cialis, and then Viagra on demand to have sex? I think this would be a new venue, wherein you can get some sort of a baseline testosterone level, let’s say with HCG, or with a very low dose of exogenous testosterone, and then use Natesto, just on demand. Right? I’m gonna go to the gym today, I go to the gym Monday, Wednesday, Friday. I want to get my levels higher on Monday, Wednesday, Friday. Take the Natesto, right? I think in a few years from now, I think that’swheree this is going to find it’s most applicability.
Dr Ramasamy: Being on Natesto, life long, three times a day, two pumps everyday, I don’t think this is going to be a life long, long term treatment option. I think it’s going to serve very well as an on demand treatment option. And I don’t think it’s even being used in the venue right now. Cause the market share for Natesto, I think it’s probably less than 1% among all testosterone therapy users.
Nelson Vergel: And one more question. Are there any data out there, on the effect of, okay, how long after a peak of testosterone, somebody feels, boosting whatever, energy, sex drive? Do we require an average, certain level, obviously everybody’s different, or can a boost in testosterone an hour, or half an hour before sex, or working out actually means better performance? That’s where I’m trying to struggle, cause I don’t think I’ve ever seen that data on this.
Dr Ramasamy: No, I don’t think we have, and some people say that muscle building doesn’t even start until two to three hours after the workout, right? So, it’s tough to know when we should be dosing this. I don’t think we have data to show that, which is why, “Oh, you should have high T levels all the time.” It’s a good idea, so you don’t have to worry about when the muscle building actually happens. To answer the question, I don’t think we have data on what the most efficacy is. But I think men will probably, and I think doctors will probably use it, in ways to feel better, right? I mean you told me, you feel the rush an hour after. And if you’s rather have the rush right before going to the gym, or right after you wake up, or right before you go to bed, that’s when you’ll want to have the rush.
Dr Ramasamy: And I think just because, it’s a steroid, right? I mean, let’s be honest here. We are dealing with a steroid, steroids make people feel better. And so, the steroid rush, whenever it is that people want to feel, they’re going to use it as on an as needed basis, on what makes them feel better.
Nelson Vergel: And what was the average peak? It was like 800, right?
Dr Ramasamy: Yes, 600 to 800, yes.
Nelson Vergel: Yeah, okay, good. Thank you.
Nelson Vergel: Oh, thank you!
Nelson Vergel: Is there anything else you want to add? As I said, I’m very surprised about the data, when I saw it, obviously, that’s why we’re having this webinar, besides you were overdue. You have a following. You have a fan club now. At excel male, and everywhere else. So, when do you think you’re going to finish the study? You’re looking for patients right now, right?
Dr Ramasamy: Yes, that’s correct. We are looking for a total of 40 patients. I anticipate to have enrolled everybody, like at least the 40 patients enrolled, by October, November. And so, we will have the complete trial data, like the six months everybody would have finished, I guess sometime around March, April.
Nelson Vergel: So how many more do you need from Miami? Or Ft. Lauderdale, I guess.
Dr Ramasamy: About 15 to 20.
Nelson Vergel: Okay, cool. I’ll get the word out.
Dr Ramasamy: Thank you, thank you.
Nelson Vergel: Hopefully, you enroll quickly. We really need this data, it’s a very interesting approach. I mean, I’ve had doctors and friends of mine that work in the field, they forwarded me your study. Your first preliminary poster, I think it was, right?
Dr Ramasamy: Yes, yes that’s correct. Yes. I will send you along the paper, and you can probably put the link along with the video. It should be published in European Urology Focus, hopefully within the next few weeks. Its already accepted, it’s just in the proof stage, so I’ll get it to you as soon as it’s published.
Nelson Vergel: Good, good. So, hey, thank you so much, looking forward to more topics from you, obviously, you know? Next time if you have even an update, maybe on the data, we can preview it. And any other studies you are enrolling right now?
Dr Ramasamy: We are also doing a study for erectile disfunction using shockwave therapy. And so those are the only two clinical trials that I’m enrolling right now.
Nelson Vergel: How about any of the stem cell work that you’ve done?
Dr Ramasamy: With the lytic stem cells, we’ve applied, actually, for an IND from the FDA to get exemptions to start using it in humans. That should hopefully be available within the next year, but I will let you know.
Nelson Vergel: Wow. Okay, good, good. Alright, that’s exciting. Alright, well thank you so much, and thank you everybody for watching the video. As I said, go to excelmale.com, register for updates, and that you again Dr. Ramasamy. See you-
Dr Ramasamy: Thank you so much, Nelson, yes.
Nelson Vergel: Bye bye.
Dr Ramasamy: Bye bye.
PART 3 OF 3 ENDS