The Cure is Here
The Cure is Here
Neurosearch has announced the results of its Phase IIB clinical trial of its dopamine stabilizer, Huntexil, originally named ACR16 when it was in preclinical development.
The findings are consistent with the results of the earlier European Phase III trial reported in February 2010. The safety and tolerability profile again looks good and a trend was found towards motor improvement. At the higher dosage tested (45 mg twice daily), there was a trend toward improvement in the Modified Motor Score of the United Huntington’s Disease Rating Scale, which was specified as the primary endpoint, and an even larger improvement in Total Motor Score. Balance, gait, eye movements, hand movements, dystonia, and chorea all showed improvements. However, the overall trend toward improvement did not reach statistical significance.
Had only the higher dose of Huntexil been tried and had the broader Total Motor Score been the pre-specified endpoint, then the results would have been successful instead of inconclusive. A clinical trial must be evaluated based on how it was originally set up; however, the results are encouraging and warrant further efforts. Determining the correct dosage for a new medicine is not easy to do and is especially difficult for drugs that affect the central nervous system (CNS). Most approved CNS drugs have required repeated Phase III trials.
Neurosearch’s next step is to talk to the regulatory agencies, including the FDA here in the U.S. to see how they should proceed in their efforts to demonstrate the effectiveness of the drug. It is likely however, that they will have to conduct another Phase III trial.
I feel...amazing! What a great day we had Saturday. The sun was shining, it was so beautiful out, and we had such a great turn out for our 1st annual Team Hope HD walk in Winston-Salem! For those who know me, I was my usual excited, all-over-the place self, so I'm sure I seemed a bit crazy and well...all over the place to those who don't know me. :) We started the walk at 11:30 and walked around the fitness trail at Bolton Park. Everyone did laps and afterwards I presented awards to: Team The Joys for the team that raised the most money at $2755, which is AMAZING; Linda Gurganus for individual that raised the most money at $335 and the Juvenile Huntington's Disease Award to Team Gage for Excellence with juvenile Huntington's Disease as they have raised a lot of awareness for juvenile HD by honoring Gage (Laura's son who has juvenile HD) and selling and wearing their Team Gage shirts. We had massage therapy and door prizes and pizza! I wish I had had time to spend and talk with everyone! I feel like I was pulled in so many directions, but it was so worth it! Josh was a tremendous help, as was Karla Gurganus and her whole family, Linda Gurganus, that whole group! I don't know what I would have done without them if they hadn't shown up early! Thank you all so much! We had a total of 50 people if you include me and Josh, people all the way from Wilmington and Jacksonville, NC! And we raised a total of $4756 with 1 or 2 more checks still expected to come in! I would definitely call that a success for our first walk!! Half of these funds will be going to HDSA NC and half will be going to the NYA. There are several people that I want to say thank you to. First of all, I've said this many times, but I want to make sure to do it again--thank you to all of those that have donated; You are the ones who made this a success. Thank you to those went out and raised the money and participated in the walk--without you, this would not have been possible! Thank you to Warren Medrano from Lundbeck for coming out. Thank you to the Old Salem Chapter AACA members who came out and donated! Thank you to Domino's on Knollwood St and Food Lion in Clemmons for their food and drink donations. Thank you to Tom Loffredo for his great massage therapy and donation and Adrienne Loffredo for taking photos. Thanks to Sean Thompson of University of Iowa for sending the PREDICT-HD materials. And thanks to HDSA national, HDSA NC and the NYA! Looking forward to doing this again next year, but bigger and better! :) Lauren Holder
This is just a quick reminder that I have a special teleseminar coming up on November 4. It’s called Life, Love & Relationships teleseminar and it’s produced by Anne Pustil the host of the Life, Love & Relationships Teleseminar. Anne Pustil is a certified therapist and coach, who works with individuals and couples to become more powerful and fulfilled in their lives and their relationships. Anne has brought together an array of professionals from the health, psychology, and coaching community to give you specific strategies and tools that will help you live your best life-a life of vibrant health, personal fulfillment, and great relationships.
To sign up for the teleseminar and see an introductory video go here:
Some of the questions that will be answered over the course of the teleseminar series include:
I will be speaking on Thursday, November 04, 2010 at 2 PM Eastern, 11 AM Pacific. I discuss how to use functional medicine to improve your health and your life.
I would also like to ask you to help us help millions of other people by telling your friends and family about this opportunity and talking about it on your Facebook, Twitter and blog (if you have one).
Again, if you are interested in joining me on Thursday, November 04, 2010 at 2 PM Eastern, 11 AM Pacific go to the link below and sign up for the teleseminar:
After you register, keep an eye out for Anne’s email with your details for listening in on the calls.
To your good health,
Mark Hyman, MD