Preliminary Approval for GM6

Last summer we saw how the Ice Bucket Challenge social movement was able to make a significant impact on ALS awareness, now we need your help to potentially save tens of thousands of people. In February 2015, Genervon will be meeting with FDA  for accelerated approval of GM6 for all ALS patient.  GM6 is very safe with no significant adverse events in any treatment group. Additionally, GM6 is efficacious including Genervon trial programs for other neurodegenerative diseases. As a person with ALS I need a treatment right now, GM6 showed that it is safe especially considering without treatment ALS is 100% fatal.

While acknowledging the paramount importance of public safety in the FDA’s drug approval process, the American people (as well as people around the globe) also believe that ALS presents a compelling case for an exception to the usual process. I have contacted my congressman and he said they do in fact have the ability to influence the decisions of the FDA. He appreciated the urgency of our request and suggested we get everyone we can to follow suit. We are asking you to reach out to your federal representative and urge them to support the immediate use of GM6 for all ALS patients. We’ve included four simple steps below to make this as easy as possible.

1. Visit and type your zip code into the search box to find your representative.

2. Once you click on your representatives name, you can find their email and mailing address on the right side of the page.

3. Download this letter (MS Word), fill in the name of your congress person along with your name and address. Physically mail it to your representative.

4. Using the email address found on your representatives web page, copy the below text and email it to them.

I am writing to express interest in the approval status of a bio-drug produced by Genervon Biopharmaceuticals LLS, known as GM604 or GM6. This drug was granted a fast track designation for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease) in 2013 and was also awarded an orphan drug designation by the FDA on March 3, 2014 for the treatment of ALS.

On January 8th, 2015, Genervon announced that it had submitted results of its single compassionate patient trial (GALS-C) to the FDA of drug candidate GM6. Next month, representatives from Genervon plan to meet with the FDA to request accelerated approval of GM6 for all ALS patients. They plan to supplement their case with evidence of demonstrated safety, statistically-significant efficacy between treated and placebo groups in biomarker data.

I fully appreciate the vast importance of the FDA’s comprehensive and thorough approval process, and the role of the agency in protecting public health. As one who has a family member (or friend) with ALS we know the tremendous hardships associated with this devastating disease.

I respectfully request and urge Genervon be given full and fair consideration as they discuss the need for accelerated approval of GM6 next month. GM6 should be advanced to conditional approval in a post-marketing surveillance program. In their phase 2 trial they demonstrated safety and waiting for a phase 3 trial will result in certain death for thousands of ALS. Currently Riluzole is only one FDA approved drug for ALS and only increases the life span of a small number of patients by a few months.

Thank you for you consideration in urging the FDA to allow for accelerated approval of GMC6 next month. Doing so would mean potential rescue from ALS for tens of thousands stricken with this terrible disease, as well as prevent this disease from striking thousands of others.

7 Responses to “ Preliminary Approval for GM6 ”

  1. Dieter Loemker

    yes i fully agree with the fast tracking we need this drug now not in 18 months time when some of us may not be here any longer i’m from Australia and can and will bring this drug into the country under what’s called the Special Access Scheme at a huge cost to me but i need this asap please get this drug thru the FDA so all of us can get the benefit of this great drug GM6.

  2. Marjorie M. Gingles

    I myself was diagnosed with ALS in October 2014 so I am relived to see a medicine finally come out to treat this devastating disease. Three men my husband and I know have died within the past 6 months because of ALS. Thank you for this vital information. I will pass this along to others and follow up to my congress person.

  3. Dieter Loemker

    I’m a MND sufferer and also a cancer sufferer so I have a double whammy as I’ve accepted my cancer with much more positive thoughts I can’t say the same for MND when faced with ones mortality there is nothing worse beyond imagination unless you are there

  4. Jennifer Dean

    Hi, I live in France and have bulbar ALS. I applaud your campaign and the approval of GM6 affects everyone around the World suffering from this dreadful disease. I implore everyone involved with ALS to do everything they can to spread the word and get this drug on the market asap.

  5. Richard Pollock

    Good Morning,
    I was just recently diagnosed with ALS, and am curious to know what went into the development and study of this treatment… Specifically I am very interested to hear whether or not embryonic stem cells were used.