Just received this e-mail from Histogen as I am sure a lot of you have.
HSC Question & Answer Session with Histogen CEO Dr. Gail K. Naughton
Q: The Phase I/II clinical trial of HSC will begin in Singapore this Spring. How will the design of this trial differ from the pilot clinical trial?
A: Like the pilot trial, the Phase I/II will focus on safety and efficacy in the application of HSC as an injectable for hair growth, but this trial will also begin to examine dosing and delivery. As such, the trial design includes a larger number of injections per treatment site, as well as a second treatment timepoint, to determine if this further enhances the results.
In addition, the Phase I/II will be a dual-site trial with a larger number of subjects (50), which will provide us will more significant safety and efficacy data.
Q: Why has Histogen chosen to perform this clinical trial in Singapore? Will there be trials in other countries as well?
A: A number of countries in Asia, including Singapore, have become leading global centers for advanced aesthetic medicine. By performing the trial in Singapore, we are able to work with experts in the hair restoration industry while pursuing opportunities to bring HSC to market sooner.
After a successful Phase I/II trial, we plan to conduct a 250 patient study in 5 countries in Asia, which can lead to Pan-Asian (excluding Japan) approval.
Regulatory requirements for clinical trials and approval in Singapore and Pan-Asia are very similar to the US and Europe, and their regulatory agencies are highly regarded worldwide. Histogen continues to work with the FDA in parallel to the Singapore trial, and hopes to be able to utilize the data gained from the Phase I/II within its US FDA Investigational New Drug (IND) submission.
Future clinical studies of HSC in other countries are also likely. We look forward to getting the upcoming trial underway, and to further evaluating potential design and locations for studies including a pilot evaluation of HSC for diffuse hair loss in women.
Q: How does HSC work?
A: When grown under proprietary conditions of very low oxygen and suspension, human newborn dermal cells act as they would in the embryonic environment, becoming stem cell-like and producing proteins that are embryonic in nature. The soluble complex of cell-signaling proteins produced through this process becomes HSC.
HSC contains a number of proteins, including follistatin, VEGF and KGF, which have been shown by leading research to be involved in hair growth, maintenance, and in the development of new hair follicles. These proteins signal existing follicles to produce new hair, and stimulate stem cells in the scalp to become brand new hair follicles.
Q: How does Histogen plan to bring HSC to market?
A: As with all of its product applications, Histogen seeks to bring HSC to market through partnerships and licenses with global industry leaders. While HSC continues to be Histogen’s lead product application, the embryonic-like soluble proteins and insoluble extracellular matrix produced through our technology process have numerous therapeutic applications. Research to date in areas such as cancer and medical device coatings have yielded very exciting results, and Histogen’s expertise lies in the development of products to meet medical needs.
Q: Histogen has recently opened a Series B financing round. What will this financing be used for, and who are Histogen’s investors?
A: Histogen’s $23M Series B round of financing was opened in December 2010, and will be utilized to fund clinical trials of HSC through market launch in Asia, continue development of our oncology program, and upscale manufacturing to meet regulatory requirements and future commercial needs. As with our first round of financing, Histogen is seeking a limited number of accredited investors for the Series B, which we hope to bring to a close this Spring.