New 2013 year predicted to be a good and very interesting for cell therapy and Regen industry. I’m going to highlight at least few reasons why it will be very exciting year for the field.
1. Upcoming results of multiple late-stage clinical trials
A lot of industry-sponsored trials have been started in previous years. We saw that all of them successfully passed early stage (Phase 1) – safety and feasibility. 2013 should be very rich year for preliminary or/ and final results of mid-to-late stages of clinical trials, which assess efficacy of the cell-based treatments. We’re expecting the announcement of results some very important trials this year (Phases 2-3):
- Athersys GVHD and stroke trials;
- Cytori cardiac cell therapy APOLLO, ADVANCE and ATHENA trials;
- Aastrom critical limb ischemia REVIVE trial;
- ImmunoCellular Therapeutics glioblastoma trial;
- Cytomedix RECOVER-Stroke trial;
- PluriStem limb ischemia trials;
- Mesoblast cardiac cell therapy trials;
- Gamida-Cell cord blood expansion by StemEx.
2. New players on pluripotent stem cell-based therapies market
Advanced Cell Technology (ACT) is the only company with ongoing embryonic stem cell-based clinical trials. We’re expecting some new players this year. BioTime just acquired Geron’s stem cell assets. More likely BioTime itself or in partnership will kick off the spinal cord injury trial, halted by Geron in 2011. Yet another potential player in 2013 – California Stem Cell. Hans Keirstead has announced that the company is hoping to get approval from FDA for the first embryonic stem cell-based trial in spinal cord injury.
ACT recently announced the initiation of iPS cell-derived human platelets program. The company is going to submit IND to FDA and hoping to get approval for the first trial this year. If they succeed, it will be world’s first commercial iPS cell-based clinical trial.
3. BigPharma to acquire cell therapy and Regen industry assets
Cell therapy and Regen industry may be a threat to Pharma industry, because it may make traditional drug models obsolete. As recognition of this threat, BigPharma started to acquire or to team up with cell therapy companies. You can look at Pfizer – Athersys, Shire – Advanced BioHealing, Gamida-Cell – Teva partnerships and acquisitions. In 2013 BigPharma companies will continue to expand their interest and acquire more cell therapy/ Regen assets. One of the recent biggest events is a partnership of Mesoblast and Teva for Phase 3 of heart failure trial in US. The trial is planning to enroll 1700 patients. It will be the largest commercial cell therapy trial in the history! If it succeed, Teva will have exclusive right to sell a product.
4. Potential market approvals
We’re expecting a few new approval on the markets. Some potential candidates to watch:
- Sanofi with MACI product for cartilage regeneration in Europe;
- Pharmicell with product Livercellgram in Korea;
- GamidaCell with product StemEx in Israel;
- Cancer vaccine by NovaRx in US;
- CellCoTec with cartilage repair product INSTRUCT;
- Osiris with Prochymal for GVHD in some countries;
- InnovaCell wit product ICES13 for stress urinary incontinence in Europe.
I hope it will be very interesting and exciting year for all of us!