- Reaction score
- 2,634
My meeting with Samumed went well, although a few very important details could not be disclosed (ie; what exactly is the molecule). In either case, the interview is below along with a photo of their poster.
Also interesting are the following PDF files found by lifelonglearning in another thread:
https://www.samumed.com/files/Samumed_Poster_238.pdf
https://www.samumed.com/files/WHC_OP_SM04554-01_Final.pdf
Enjoy.
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Q) Dr. Bergfeld is lead of Samumed?
A) Dr. Bergfeld is a consultant.
Q) Who is the lead doctor at Samumed?
A) We have several doctors, I'm (Dr. Yusuf Yazici) the chief medical officer.
Q) Can you tell us more about Samumed's Phase 2B trial and why it was needed?
A) We're presenting on Saturday our oral presentation. We finished our Phase 2 but we don't have the results as it just closed a couple days ago. We're still going through the analysis and data, so we'll answers in upcoming meetings. *NOTE: Not sure if he said meetings or weeks.
Q) Are you aware of the 21st century act and do you feel it will benefit Samumed in a faster release? Other thoughts?
A) Yes, we are aware of that of course, but there is as you know a house version and a senate version. So it's not clear as to how the 21st Century Act is going to be in it's final version. So we'll see what it means, but I don't think anyone knows how it will be.
Q) Can you tell us how Samumed works? What's the process?
A) It's a pharmaceutical company, based in San Diego, a private company and we have 5 programs in 3 different disease areas (arthritis is one area). Then we have skin with alopecia.
Q) What's the process like for Samumed SM04554? What is actually in the product?
A) We don't disclose what's in the product, but it's a small molecule. But it has effects on the WNT pathway.
Q) Is it similar to Histogen's HSC?
A) I'm not sure how Histogen's product works either, so I can't comment on that.
Q) Since Phase II is complete, and once results are out and you're satisfied with them, what would be the turn around time to make it a commercially available product?
A) If you know, let me know, haha. But we have to do further studies, Phase 3 with FDA and see what they have in mind. Then we have to talk to our site's investigators so we have to see what the data shows and see what the path would be. It's difficult to say what the timeline would be.
Q) Ballpark figure? A couple or few years?
A) Well, the normal development time it's at least a few years.
Q) But you've already been in clinical trials for a few years.
A) So we finished our Phase 1, we finished earlier this year. And we just finished 2.
Q) That's incredibly quick. How did you manage that?
A) I think this is ballpark average, but there are longer and shorter trials but I think we're within the average lengths.
Q) Are you aware of the new deregulated laws in Japan for expedited clinical trials?
A) No, I was not aware of that. What happens with them. But I will find out more about this. *NOTE: Samumed's SM product is not cell based. I think the new regulations in Japan are for cell based therapies only.
Q) Since it's not a stem cell treatment, is it more like a growth factor treatment, vegf.... or?
A) Well, we do have a novel target, but we cannot disclose it and I cannot say much at this time.
Q) When would Phase 2 results be made public?
A) Next year we hope after several meetings. *NOTE: A more specific date was not specified.
Q) Can you comment on results from first trial?
A) First trial was safety with three doses, treatments was for 14 days and 14 days of observation for a total of 28 days without any adverse events, or at least any serious adverse events. We saw trends in slowing down and growth of hair loss. *NOTE: The middle dose I think will be used in the next trial.
Q) We're women used in the trial?
A) No, just men. *NOTE: I think this may work for women as well though as it targets WNT factors rather than androgen receptors.
Q) Is there a possibility that this could work for women?
A) Our phase 2 is only men also, so now we're only focused on men.
Q) Once the product is commercially available, will it be available for women or will it be exclusively for men?
A) It depends on the label. So, it's hard to say what the final label will be, depending on the safety data.
Q) Would id be available 'over-the-counter' or doctor prescribed.
A) It might turn into 'OTC' over the years but initially it will be doctor prescribed.
Q) The hair results from Phase 1, did you see any rejuvination of follicles to their original size?
A) No, we didn't look into that as Phase 1 was safety only. There were no biopsies or macro photography done during Phase 1. *NOTE: It doesn't seem like FDA allows efficacy for phase I relative to Samumed but Replicel did have some efficacy reports. Odd.
Q) In January, could we see some photographs of the next phase results?
A) Well, I'm not sure if January is enough time, because we have to go through a lot of analysis.
Q) How many people were involved in the second trial?
A) Yes. We had 200 people total (100 in SM, 100 in Placebo).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Poster:
Also interesting are the following PDF files found by lifelonglearning in another thread:
https://www.samumed.com/files/Samumed_Poster_238.pdf
https://www.samumed.com/files/WHC_OP_SM04554-01_Final.pdf
Enjoy.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Q) Dr. Bergfeld is lead of Samumed?
A) Dr. Bergfeld is a consultant.
Q) Who is the lead doctor at Samumed?
A) We have several doctors, I'm (Dr. Yusuf Yazici) the chief medical officer.
Q) Can you tell us more about Samumed's Phase 2B trial and why it was needed?
A) We're presenting on Saturday our oral presentation. We finished our Phase 2 but we don't have the results as it just closed a couple days ago. We're still going through the analysis and data, so we'll answers in upcoming meetings. *NOTE: Not sure if he said meetings or weeks.
Q) Are you aware of the 21st century act and do you feel it will benefit Samumed in a faster release? Other thoughts?
A) Yes, we are aware of that of course, but there is as you know a house version and a senate version. So it's not clear as to how the 21st Century Act is going to be in it's final version. So we'll see what it means, but I don't think anyone knows how it will be.
Q) Can you tell us how Samumed works? What's the process?
A) It's a pharmaceutical company, based in San Diego, a private company and we have 5 programs in 3 different disease areas (arthritis is one area). Then we have skin with alopecia.
Q) What's the process like for Samumed SM04554? What is actually in the product?
A) We don't disclose what's in the product, but it's a small molecule. But it has effects on the WNT pathway.
Q) Is it similar to Histogen's HSC?
A) I'm not sure how Histogen's product works either, so I can't comment on that.
Q) Since Phase II is complete, and once results are out and you're satisfied with them, what would be the turn around time to make it a commercially available product?
A) If you know, let me know, haha. But we have to do further studies, Phase 3 with FDA and see what they have in mind. Then we have to talk to our site's investigators so we have to see what the data shows and see what the path would be. It's difficult to say what the timeline would be.
Q) Ballpark figure? A couple or few years?
A) Well, the normal development time it's at least a few years.
Q) But you've already been in clinical trials for a few years.
A) So we finished our Phase 1, we finished earlier this year. And we just finished 2.
Q) That's incredibly quick. How did you manage that?
A) I think this is ballpark average, but there are longer and shorter trials but I think we're within the average lengths.
Q) Are you aware of the new deregulated laws in Japan for expedited clinical trials?
A) No, I was not aware of that. What happens with them. But I will find out more about this. *NOTE: Samumed's SM product is not cell based. I think the new regulations in Japan are for cell based therapies only.
Q) Since it's not a stem cell treatment, is it more like a growth factor treatment, vegf.... or?
A) Well, we do have a novel target, but we cannot disclose it and I cannot say much at this time.
Q) When would Phase 2 results be made public?
A) Next year we hope after several meetings. *NOTE: A more specific date was not specified.
Q) Can you comment on results from first trial?
A) First trial was safety with three doses, treatments was for 14 days and 14 days of observation for a total of 28 days without any adverse events, or at least any serious adverse events. We saw trends in slowing down and growth of hair loss. *NOTE: The middle dose I think will be used in the next trial.
Q) We're women used in the trial?
A) No, just men. *NOTE: I think this may work for women as well though as it targets WNT factors rather than androgen receptors.
Q) Is there a possibility that this could work for women?
A) Our phase 2 is only men also, so now we're only focused on men.
Q) Once the product is commercially available, will it be available for women or will it be exclusively for men?
A) It depends on the label. So, it's hard to say what the final label will be, depending on the safety data.
Q) Would id be available 'over-the-counter' or doctor prescribed.
A) It might turn into 'OTC' over the years but initially it will be doctor prescribed.
Q) The hair results from Phase 1, did you see any rejuvination of follicles to their original size?
A) No, we didn't look into that as Phase 1 was safety only. There were no biopsies or macro photography done during Phase 1. *NOTE: It doesn't seem like FDA allows efficacy for phase I relative to Samumed but Replicel did have some efficacy reports. Odd.
Q) In January, could we see some photographs of the next phase results?
A) Well, I'm not sure if January is enough time, because we have to go through a lot of analysis.
Q) How many people were involved in the second trial?
A) Yes. We had 200 people total (100 in SM, 100 in Placebo).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Poster:
