10 companies to watch in 2012

by Alexey Bersenev on January 27, 2012 · 0 comments

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2011 was very interesting year for cell therapy industry. We’re expecting even more exciting news this year. Today I’d like to overview some companies, which, in my opinion, could be worth watching in 2012. I’m giving a special attention to the companies:

  • with therapeutic platforms on clinical trials
  • with unique therapeutic approaches
  • with products which just entered the market

Advanced Cell Technology (OTC:ACTC ,US)
The whole world is eagerly watching the first results of clinical trials, involved embryonic stem cells. Advanced Cell Technology (ACT) just release a two cases report for treatment of for macular degeneration. No adverse events or complications was reported in 4-month outcome. Some signs of vision improvement has been observed. 4 patients were treated so far, including 3 in US and 1 in UK. ACT is expecting to report more interim results of its Phase 1/2 trial later this year. If ACT will succeed at this stage and will able to show long-term safety, it will shape and determine the future development and commercialization of embryonic stem cell-based products.

Sangamo Biosciences (Nasdaq:SGMO, US)
The company is pioneering a new sophisticated approach for treatment of HIV patients by cell gene therapy. The approach is very unique and involves targeting the chemokine molecule CCR5 in patient’s T-cells by ZNFs. The company recently reported data from Phase 1 trial. Sangamo initiated two new Phase 2 HIV clinical trials ahead the schedule. So, this year we’re expecting to see interim results of HIV Phase 2, as well as results of other trials conducting by Sangamo. I think, it’s very promising approach in gene therapy, which eventually will enter the market.

ImmunoCellular Therapeutics (OTC:IMUC, US)
IMUC is developing a immunocellular therapy for treatment of glioblastoma. This is the only cell therapy in clinical trial phase, which precisely target cancer stem cells. The preliminary results of Phase 2, reported in 2011, were very compelling. The company is expecting to present interim results of Phase 2 (expanded to 21 centers) at the end of the year. Many professionals have a high expectations about Phase 2 trial.

Human Stem Cell Institute (MICEX:ISKJ, Russia)
HSCI just got an authorization for sales of the first gene therapy drug in Russia. It will be interesting to watch a commercialization of gene therapy on regional market. How much could it make in profit? Will physicians prescribe it? HSCI also has a cell therapy product on the market. SPRS-therapy is an autologous fibroblasts for cosmetic applications. The first approved cell therapy product in Russia brought about $0.5M USD in revenue last year (personal communication with CEO). It will be interesting to compare revenue of SPRS-therapy in Russian market and Laviv (Fibrocell) in US market.

Dendreon (Nasdaq:DNDN, US)
Last year we watched how the first cell cancer vaccine was feeling on the market. We saw how dramatically Dendreon’s shares fell after missed sales forecast. Nonetheless, the first cellular immunotherapeutic product on the market has generated $228M revenue in 2011. The company is optimistic about this year and forecast for $500M in 2012 sales. We will continue to watch Dendreon closely in 2012.

Medipost (KOSDAQ:078160, S. Korea)
Two weeks ago, Medipost got a market approval for the first allogeneic stem cell drug – Cartistem. in Korea. This approval is result of 10 years hard work, including controlled clinical trials. It will be very interesting to watch how well allogeneic “off-the-shelf” stem cell product will be doing on the regional market. Now Medipost is looking for a strategic partners abroad for international sales.

Northwest Biotherapeutics (OTCBB:NWBO, US)
The company is developing a dendritic cell-based cancer vaccines for more than a decade. NWBO is a main competitor for the Dendreon and IMUC on a shared market with a similar therapeutic approach. Now NWBO got very close to the point of possible approval of DCVax-Prostate for non-metastatic prostate cancer. Phase 3 trial includes more than 600 patients in multiple sites. This year, the company is expanding DCVax-L trial for glioblastoma. 240 patients in more than 25 sites will be enrolled in Phase 2 DCVax-L trial. We’re expecting to hear some interim results later this year.

Mesoblast Limited (ASX:MSB, Australia)
Mesoblast was one of public companies which was feeling well on the market in 2011. Company’s strong cash position allows to develop multiple products simultaneously. The recent strategic alliances with Teva and Lonza captured a lot of attention to the company. In 2012 we’re expecting to hear interim results of FDA-approved trial for type 2 diabetes and, possibly, results of other trials. Company got very close to the point of market approval.

Osiris (Nasdaq:OSIR, US)
Osiris is trying very hard to enter the market with a first off-the-shelf mesenchymal stem cell product in US. They had many ups and downs. Now, Osiris has finished enrollment in Phase 3 trial for GvHD. So, we’re eagerly waiting of results. If results will be positive, more likely, Prochymal will enter the market. Also, we’re expecting to hear some news from Phase 3 trial for Crohn’s disease.

Capricor (private, US)
This is the only private company in my review. The company with unique approach to regenerate the heart – by using cardiac progenitor cells. Only the company with women’s management team. Capricor has autologous and allogeneic Phase 2 clinical trials. The positive results of CADUCEUS and launch Phase 2 of ALLSTAR trials have captured a lot of attention to the company.

Disclosure: I don’t own stock and I don’t have any financial interest in any company mentioned in this post.

RegenMed Digest on Stem Cell Assays is sponsored by Regenerative Medicine Jobs. Please visit Regenerative Medicine Jobs for recent position openings.

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