Preliminary research into cell therapy companies
[no action needed but please read today or tomorrow]
- Dendreon (product: blood cells for prostate cancer) was founded in 1992, under the name "Activated Cell Therapy". Final results from first human trials were obtained in 2000, at which point it IPOed. In 2006, they anticipated FDA approval soon and built a manufacturing facility. In 2007 FDA went back and demanded additional evidence. In 2009 results from a Phase III trial came back positive (as an aside, biotech companies get thrown about like the James Caird by this stuff; the positive result boosted the stock price by a factor of six, from $4 to $20.) FDA gave final approval in 2010. Stock was high but then insta-crashed 70% in 2011 because of slow sales, caused by uncertainty among doctors about whether insurance would reimburse.
- Isolagen (product: fibroblast cell injection for cosmetics) was founded in 1995. I'm not going to bother tracing their whole history because it's so bloody complicated, but the short version: they started treating a few hundred patients shortly after they were founded. In 1997 FDA announced new regulations to comply with. In 1999 they filed a request for approval (IND) from the FDA. In 2003, they both IPOed anticipating imminent FDA approval and created European subsidiaries for regulatory reasons, setting up a bunch of UK clinics. In 2005 a study showed poor results and FDA approval was not obtained. They did another study. UK operations had unexpectedly high costs and that branch went bankrupt in 2007. After main company also went bankrupt, company re-organized as "Fibrocell" in 2009 again seeking FDA approval. FDA approval was finally obtained in 2011, at which point the company's market cap appears to have been well under $100M. They applied for approval to use the same tech to treat scars; a 2013 Phase II study was successful causing the stock to jump 3,000% (yes, three thousand percent).
- Forticell (product: dermal cells for wound healing) was founded in 1991, four years after the founder developed the technology to save his son (at least according to corp. website). IPO in 1996. Initial approval by FDA in 2001; they continued applying for additional approvals for other uses like diabetic ulcers. Launched a Phase III trial in 2004. Something Bad happened - not sure what, since all the easy to find news stories are PR releases which only mention good news - and they had to seek money in 2006 under desperate terms, including doing a 1:15 reverse stock split. Appear to have struggled along and changed their name to Forticell; website is still up but stock is now worthless.