Hello all! We received a request from a poster to provide an update on this forum. We are pleased to share the news that an interview with Histogen CEO Dr. Gail Naughton will be published in the official journal of the ISHRS, and includes some updates that may be of interest. Please look for this online within the next 2 weeks.
Additionally Dr. Craig Ziering, hair restoration specialist and primary investigator on Histogen’s hair regrowth clinical trial, will indeed be presenting findings from the trial at the upcoming ISHRS International Meeting in Amsterdam. Histogen plans to address the presentation in a press release soon.
Please feel free to contact us through our website with any questions: www.histogen.com.
This is the letter from Histogen.
“Thank you for your interest and message.
Histogen’s Hair Stimulating Complex (HSC) is currently in clinical trials as an injectable for hair regrowth in Male Pattern Hair Loss. More information, and the latest news from our pilot clinical trial of HSC, can be found on the news section of our website at: http://www.histogen.com/aboutus/news_events.htm#25.
Our next clinical trial is scheduled to begin in early 2011 in Singapore. While we dont expect our product to be launched in the US until the 2015 timeframe, Histogen hopes that we can launch sooner outside the US if our international trials go well. However, that timeframe would also be a few years out. As an estimation, Histogen hopes to get product approval in Asia by mid-2013. Histogen expects that launching the HSC product in the EU will be around the same time as a US product in 2015. As the product progresses through development, Histogen will identify whether trials in the UK/EU are necessary.
As for hair loss in women, the Histogen team and hair specialists we work with believe that our product should work in women. While these initial studies are focused on male pattern hair loss, Histogen is considering a small side study for hair loss in women and diffused hair loss.
If I can answer any further questions, please feel free to contact me directly at the email below.
Best regards,
Thomas L Hubka
ReGenica Brand Manager”
Major development:
San Diego-based Histogen, a developer of regenerative medicine products, announced today that it has raised $10M in a Series A financing round. The financing came from private investors, including Secure Medical, Leonard Lavin, Lordship Ventures, and Angus Mitchell. Histogen is developing regenerative medicine products which do not contain embryonic stem cells or animal components, and are being applied to hair regrowth, skincare, and oncology. The firm said it is in the midst of a $23M, Series B financing which already has commitments. Histogen said it is scheduled to begin a Phase I/II clinical trail of a hair stimulating product in Spring 2011, and is also in the process of beginning a clinical study for a compound for the treatment of carcinomatosis.
Histogen Announces Completion of Series A Financing
SAN DIEGO, December 1, 2010 – Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, today announced the successful completion of its Series A financing at $10 million. Among other private investors, Secure Medical, Leonard Lavin, Lordship Ventures and Angus Mitchell brought the round to a close.
With its pilot clinical trial for hair regrowth completed, a skincare line launched, and exciting preclinical data in applications including oncology, Histogen has added significant value which was recognized by the Company’s new and existing shareholders. In addition, Histogen has recently moved into a new facility that will allow for up-scaled manufacturing for its upcoming clinical trials, and later commercial production.
“With the Series A completed, we are excited to build on the momentum Histogen has created over the past two years, and further advance the Company’s rich product portfolio,” said Gail K. Naughton, Ph.D., CEO and Chairman of the Board for Histogen. “We have made significant strides in several important research areas, advanced partnership discussions, and are on track to reach key value inflection points in 2011.”
This successful completion follows the announcement of initial Series A financing in May 2008. Simultaneously, Histogen opens its Series B financing, which has been approved up to $23 million. The Series B was opened by Angus Mitchell, and Histogen has already received further commitments toward that round.
The Company is scheduled to begin a Phase I/II clinical trial of its Hair Stimulating Complex (HSC) in Singapore in Spring 2011, and hopes to also begin a clinical study of its soluble human extracellular matrix (hECM) for the treatment of carcinomatosis, a rapidly progressing and debilitating cancer, mid-year.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen’s proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families – a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.
These are some promising times…
From HS..Apparently, Histogens trial has been pushed back to the end of May now. Heres a copy of some correspondence posted on HS recently.
Dear ,
Thanks for your patience.
We are starting phase 1/2 in Singapore before the end of May and hope to have phase 3 pan-Asian data by Sept 2012 for an NDA submission and 2013 approval. (hopefull Q2 2013).
We will be starting to collect info on volunteers shortly.
Please write me in May for an update.
Thanks and take care,
Gail