Question 1:
> What progress has been made towards the commencement of clinical trials either within the United States or outside of the United States where you suggested potential partnerships in the interview (Turkey/Mexico/Japan)? Can you divulge any information on how you plan to investigate HSC in the next planned trial? For instance, multiple dosages, repeat dosages at different time intervals, etc.
Histogen has found a license partner in Mexico, and initial meetings with the COFEPRIS have been completed to discuss conducting a definitive trial in Mexico for hair loss in men. The proposed trial would be 330 patients across 3 clinical sites, with dosing of 50 0.1cc injections at baseline, 6 weeks and 12 weeks. Primary safety and efficacy will be collected at week 24.
Histogen is also in late-stage negotiations with a potential HSC partner in China, and plans to make a formal announcement of that partnership soon. In the United States, Histogen is planning a Phase I trial in women and a Phase II trial in men as the next clinical steps. Clinical sites for both US trials have already been identified.
> Question 2:
> Does your initial timeline of potential market release outside of the United States by 2017-18 still possible? If yes, where do you believe this treatment will be available?
At this time, we believe that HSC treatment will be on the market first in Mexico, which is an excellent aesthetic tourism market for products like HSC. Following Mexico, the US and Asia continue to be are our target regions for HSC development and introduction. If a worldwide partner for HSC was secured, we could then prioritize clinical development in Europe as well.
> Question 3:
> Do you believe that additional dosages of HSC will increase its efficacy and improve further hair regrowth?
Yes. In Dr. Ziering's Investigator-Initiated Trial in men and women, he saw excellent results with 4 treatment timepoints and a total of 120 injections.
> Question 4:
> It has been mentioned that your company is currently trying to raise capital for clinical trials and product development. Have these fundraising efforts been successful or are you still trying to secure adequate funds for product development and commercialization?
We are in late-stage negotiations with an HSC partner in Asia, who will also be making a sizable equity investment. This will be intrumental to the advancement of HSC over the next 1-2 years. Histogen will be seeking to close the remainder of its Series D funding as well, to prepare the Company for an IPO.
> Question 5:
> I know the employees are very busy at Histogen and press releases or presentations made available to the public are scarce. However, will future clinical trials be announced? I am positive a great deal of the public would highly appreciate that and volunteer to participate.
Yes, Histogen plans to announce the start of HSC clinical trials here in the United States.
> Question 6:
> Is there any information you can disclose at this time regarding potential launch of your product HSC, estimated cost of the procedure when its released or new data to the public?
We are currently doing market analysis with our partners in each geographic area to determine the optimum HSC price point for Histogen, our partners and the patients. We expect it to be in line with currently available hair loss treatments.
> Question 7:
> Lastly, is there any way you would be willing to provide any supplemental documents from your latest presentation at the Stem Cell Summit? It would be greatly appreciated.
Attached is the Stem Cell Summit presentation and an HSC overview which contains more information about the science behind HSC.
This is all very exciting news! Lets hope and pray there are no more hiccups along the way. To Dr. Gail Naughton and Eileen Brandt, if you are reading this, thank you so much again for your time, patience, and generosity for even providing me with any answers regarding your company and its pipeline. It is truly appreciated.
source:https://www.hairlosstalk.com/
