At the end of the year I’d like to overview the most notable events in cell therapy and regenerative medicine industry. What made the headlines in mass media? What events were highly discussed in professional communities? It was very eventful year, but I’ve picked 10, most important in my opinion.
1. Geron ended stem cell programs
It was the most discussed news this year. Big hope for a spinal cord injury trial, big loss for a field. Many professionals noted it as the biggest story of the year.
Despite the company’s official comment, which points to “purely business decision”, many professionals think that the “lack of impressive preliminary results” also have played a role. 5 patients have been treated so far and no adverse events were reported. The company is seeking now a partner which could take over of trial. The “Geron Effect” on the cell therapy industry remains to be seen, but for some developers, scientists and patients it’s a big loss.
We will remember Geron as a pioneer in clinical translation of embryonic stem cell therapy, prototype developer and trailblazer in regulatory path. Rest in peace Geron!
2. First patients treated with embryonic stem cell products
Despite the Geron’s trial discontinuation, five spinal cord injury patients were treated. So far, none of them developed any complications or adverse events related to treatment as far as we know. We don’t have any information about functional improvement in disease course.
Yet another company – Advanced Cell Technology (ACT) continues to enroll and treat the patients with eye diseases. ACT runs two Phase 1/2 trials in US (1/2) and one trial in UK. We don’t have information about the number of patients which have been treated so far and preliminary results, but we’re expecting to get it pretty soon.
3. Approval of world’s first stem cell therapeutic drug for non-homologous use
South Korean company FCB PharmiCell got an approval by Korean FDA (KFDA) for commercial sales of the first stem cell product for non-homologous use (post acute myocardial infarction) – HeartiCellgram. This is an autologous bone marrow-derived product, enriched for mesenchymal stem cells.
According the Scientist:
However, there has been concern over a lack of independent validation of the treatment, Reuters reports, as FCB-Pharmicell’s new product is yet to be vetted by a peer review publication.
In terms of cost/ benefit ratio, you will pay $19,000 USD for a 6% improvement in the left ventricular ejection fraction.
4. “Dendreon Effect”
After remarkable approval of the first cellular immunotherapeutic cancer vaccine on the market, the whole field was precisely watching Dendreon’s performance. A good news came up first – The most expensive cell therapy drug Provenge gets reimbursement approval from Medicare! But a bit later, the company announced that the earnings for Provenge missed its forecasts and sales will slow down. Dendreon’s shares fell dramatically. Investors lost the trust and confidence.
The failure was so painful, so shocking, it erased two-thirds of the company’s stock value—about $3 billion. It even started a “Dendreon flu” that dragged down biotech stock indexes.
More on an effect:
In early August, IMUC stock fell from approximately $2.00 to $1.50, dragged down by another cancer vaccine company, Dendreon (DNDN). DNDN shares plummeted from roughly $35 down to $12, due to poor sales and a reduced outlook for its prostate cancer drug Provenge. This “Dendreon Effect” pulled down the share price of several companies developing cancer vaccines.
5. First personalized aesthetic cell therapy approved by FDA
Fibrocell Science announces FDA approval for the first personalized aesthetic cell therapy in US. laVív® (azficel-T) is a autologous cell product, based on patient’s skin fibroblasts. This product will be commercially used in adult patients with facial wrinkles. The cost for a course could vary $1,600 – 3,300 USD. We can’t wait the first sales results and post-marketing analysis. R.I.P. Botox?
6. New gene therapy drug approved on the market
Russian company Human Stem Cell Institute announced approval of gene therapy drug for treatment of peripheral arterial disease. This is the first gene product approved outside of China. Neovasculogen (VEGF) stimulates angiogenesis and could be considered as the first gene drug in regenerative medicine. Read more in interview with CEO.
7. The biggest deal in the history of regenerative medicine industry
This year we’ve witnessed the biggest deal in regenerative medicine which was ever made. Biopharmaceutical giant Shire acquired Advanced BioHealing for $750 million USD in cash. This was a clear proof that regenerative medicine investors can get a big cash-on-cash return. This deal broke the long-term persistent VC’s dogma that “healthcare returns just can’t match tech returns“. We can!
8. The first product approved for cell tracking in clinical trials
Celsense announced FDA approval for the first use of its cell tracking imaging product in clinical trial. This is remarkable approval! Now we have a possibility to track cells after transplant and gain more knowledge about mechanisms of their therapeutic action.
9. Dubious stem cell clinic closed
German XCell Center has been forced to close by authorities. It was a biggest “stem cell clinic” in the western world and famous “stem cell tourism” center. You can read more here and here. This case have shown that authorities can deal with unproven “stem cell treatments”. “Stem cell tourism” is a big business and should be regulated.
10. Professional community online is growing strong!
Cell therapy online community grew this year tremendously. In the era of Internet we have to form and maintain professional communities online!
First of all, I’d like to note LinkedIn and Twitter. That’s where all of action going on right now! I’m discussing news with professionals every day using these platforms. Cell Therapy Industry group (account required) on LinkedIn has more than 2300 members and continue to grow up. A lot of discussions happened on a Twitter. I’d mention some people worth to follow: @celltherapy, @Prof_ChrisMason , @david_brindley, @natashadavie, @BLLPHD, @pknoepfler.
Also I’d like to mention some new arrivals:
Cell Therapy Bioprocessing Tools and Reagents Database (ISCT pass-log required);
Cell Therapy Trials tracking on a Twitter
Join our community today! We can and we should discuss any news and events openly and promptly!
PS: It was very interesting and remarkable year! Full of exciting news and events. I’d expect even more in 2012. I’m waiting a fountain of good news!