Post 14 of 18 - 18 Posts - 18 Months - Road to a Million
by, 07-10-2012 at 11:51 AM (2374 Views)
As you can see the stock is at its lowest point that I remember since the FDA approval. The road to a Million actually is taking longer than I expected
Delays simply have to be expected as ACT is paving a new road, and it simply takes time. The 100 percent success of the trials so far is a strong indication that the science works and works perfectly. I have a number of links below for you to review, but perhaps the biggest one is the Federal bill to fast track Health solutions. Simply stated, new solutions to health issues can be fast tracked to production should the initial success in testing demand it. Going forward this single event could have a major impact on how long it takes ACT to get thru the trials and out to the public.
I want to include the most recent blog by the CEO Gary Rabin. He has summarized the delays and the progress being made. I am 100 percent convinced that ACT's programs will work and success will be achieved.
See you next Month.
Our clinical trials in the U.S. and U.K. continue to progress well, though at a little slower pace than we have hoped. We have, as of today, treated eight patients between the three ongoing trials. All are doing remarkably well – no safety issues whatsoever, and we continue to receive evidence of the ability of the injected RPE cells to impact positively on vision. Our most recent patient, treated Friday the 29th, was a Stargardt’s Disease sufferer, with the surgery conducted by Dr. Bainbridge at Moorfields Eye Hospital in London. While it is too early to say anything about that patient, for the other seven dry age-related macular degeneration (dry AMD) and Stargardt’s patients, we can report that we have seen both subjective and objective evidence of improved visual acuity and quality of vision (ability to see colors better, etc). Importantly, the effects appear to persist, with our first two patients closing in on the one year mark this month and maintaining the increases in visual acuity we measured shortly after their treatment. I emphasize that this is preliminary data, and we really need many more patients and data points, but it is very encouraging and we believe that we are on the road to providing a treatment for these devastating diseases. Before Friday’s treatment, we had two consecutive last-minute cancellations, costing us nearly a month’s delay in the UK trial. One patient had a (very rare) allergic reaction, and another patient was disqualified prior to treatment due to the need to treat a non-related medical event. Both matters disqualified the patients within days of their planned surgeries.
In the U.S., we will be conducting the fourth Stargardt’s treatment (and the first of the second 100,000 cell cohort) shortly, and have screened and identified the likely fourth AMD patient, whom we anticipate treating in July, pending DSMB approval. We will also plan to treat the third UK patient in July at Moorfields. As we now have multiple centers screening in the U.S., and will soon have multiple centers in the UK, we expect that this level of redundancy will allow us to have a second center step in shortly after any last-minute patient cancellations.
As we have previously announced, our Data and Safety Monitoring Board (DSMB) has approved the treatment of the remaining two patients in the first cohort of the U.K. Stargardt’s trial, as well as the first patient of the second cohort (now at a dose of 100,000 cells) in the U.S. Stargardt’s trial. We have submitted the data package for the first cohort of patients for the dry AMD trial, and await their review with the hope that we will soon receive the green light to move up to the 100,000 cell dose for that trial as well. I will keep you posted as we treat additional patients this summer, and you should expect to start hearing about additional trial sites (some yet to be announced) also initiating patient treatments.
My last remark on the trials is to share with you how proud I am that our company has attracted some of the leading eye hospitals and retinal surgeons around the world to work with us. What other small biotech company can boast about a team like ours?! Their expertise has been invaluable in this phase of our trials, and along with our expert consultants and board members, we are tapping into this great resource as we set our sights on the next targets: clinical endpoints for Phase II and III of the trials.
Federal bill to fast track Health solutions
Trials now starting in Korea.
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