The post below was made by member, Zee, in the Pulmonary section. I found the response to be outrageous in terms of length of time until a conclusion could be made and sent it over to Dr. Centeno who founded ICMS. He has now directed a press release be issued which highlights that the ICMS reimplant registry methodology is superior to the FDA process in balancing safety with access. This is what I am preaching about Getting the Ball Rolling. Zee has taken a giant step towards making an effort to do something. We cannot afford to be apathetic. ICMS is a way that all of us can make an impact. We can support the grassroots effort by posting on the www.safestemcells.org site and every other place that we normally communicate via internet. This includes e-mail, blogs, forums, comments to articles, Twitter, Digg, Facebook, My Space and the dozens of other social network sites. We need to repeat the message over and over to get people to join us in this fight.
Zee's Post:
On August 5, 2009, NIAID, a division of NIH sent an email indicating that Dynavax may have picked up the ISS Stimulatory Sequence for treating and curing asthma and COPD. I did contct Dynavax yesterday and here is the response I received today:
Dear Mr. _ _ _ _;
First off, please let me state that we regret that you are suffering from this debilitating disease. Please note that DVAX has a collaborative program with AstraZeneca in which we aim to develop Immunostimulatory CpG-containing DNA sequences for the treatment of Asthma and COPD. These sequences are stimulating the TLR9 pathway in the airways and have indeed been shown in mouse models to heal the asthma phenotype (both in our hands and in the hands of others, such as the study you refer to in your email below). This collaboration between DVAX and AstraZeneca started in September 2007 and is progressing well with the nomination of a Clinical Candidate in 2008. However, as you may be aware, it may take 10-15 years for such a compound to enter the market, and the actual time for this particular compound is hard to predict and subject to possible failure in during the clinical trial path. In spite of this, we have a lot of faith in our current approach and believe it may potentially make a big difference to patients, if it should reach the market.
With the best wishes for your health,
With kind regards,
Linh Chu
Project Manager Asthma Program
http://www.dynavax.com/asthma.html
http://www.dynavax.com/contact.html
--------------------------------------------------------------------------------
From: _ _ _ _
Sent: Thursday, August 06, 2009 1:15 PM
To: Chu, Linh
Subject: Re: Asthma Project
Dear Linh Chu:
Thanks for getting back wtih me. I was referred to you by NIAID in the NIH. I had approached them to pick up an in house study of the ISS Stimulatory Process (DNA Vaccine) for versing asthma and asthma related COPD http://health.dailynewscentral.com/c...iew/000196/74/. Although NIAID's response was pretty vague, their mention of your company's name appeared to imply that you picked up this study. Would you please confirm as to whether or not you are picking it up? If you are going to do this, please indicate your estimated commencement of enrollment for a phase I human trials.
If you are not picking it up, I will continue my search for someone in the public and/or private sector to do this study. NIAID also mentioned that the treatment appeared to offer mixed results in Ragweed sufferers. However, I am not sure where they are going with this. It is a well established fact that a good percentage of all patients who die from asthma or asthma related COPD are not allergic to anything. I am one of them. I lost the use of my right lung following the flu in May 2009. I am one of those people that has trouble with infection in the presence of asthma.
Drop me a line and let me know what your thoughts are. I won't continue my calling if I know for sure someone is going to pick it up. Also, let me know if anything may be posted on a patient website concerning this. I participate in http://www.stemcellpioneers.com and http://www.copdliving.com There are many COPD patients involed with these sites and the medical community hasn't offered them much.
Sincerely,
Zee
Zee's Post:
On August 5, 2009, NIAID, a division of NIH sent an email indicating that Dynavax may have picked up the ISS Stimulatory Sequence for treating and curing asthma and COPD. I did contct Dynavax yesterday and here is the response I received today:
Dear Mr. _ _ _ _;
First off, please let me state that we regret that you are suffering from this debilitating disease. Please note that DVAX has a collaborative program with AstraZeneca in which we aim to develop Immunostimulatory CpG-containing DNA sequences for the treatment of Asthma and COPD. These sequences are stimulating the TLR9 pathway in the airways and have indeed been shown in mouse models to heal the asthma phenotype (both in our hands and in the hands of others, such as the study you refer to in your email below). This collaboration between DVAX and AstraZeneca started in September 2007 and is progressing well with the nomination of a Clinical Candidate in 2008. However, as you may be aware, it may take 10-15 years for such a compound to enter the market, and the actual time for this particular compound is hard to predict and subject to possible failure in during the clinical trial path. In spite of this, we have a lot of faith in our current approach and believe it may potentially make a big difference to patients, if it should reach the market.
With the best wishes for your health,
With kind regards,
Linh Chu
Project Manager Asthma Program
http://www.dynavax.com/asthma.html
http://www.dynavax.com/contact.html
--------------------------------------------------------------------------------
From: _ _ _ _
Sent: Thursday, August 06, 2009 1:15 PM
To: Chu, Linh
Subject: Re: Asthma Project
Dear Linh Chu:
Thanks for getting back wtih me. I was referred to you by NIAID in the NIH. I had approached them to pick up an in house study of the ISS Stimulatory Process (DNA Vaccine) for versing asthma and asthma related COPD http://health.dailynewscentral.com/c...iew/000196/74/. Although NIAID's response was pretty vague, their mention of your company's name appeared to imply that you picked up this study. Would you please confirm as to whether or not you are picking it up? If you are going to do this, please indicate your estimated commencement of enrollment for a phase I human trials.
If you are not picking it up, I will continue my search for someone in the public and/or private sector to do this study. NIAID also mentioned that the treatment appeared to offer mixed results in Ragweed sufferers. However, I am not sure where they are going with this. It is a well established fact that a good percentage of all patients who die from asthma or asthma related COPD are not allergic to anything. I am one of them. I lost the use of my right lung following the flu in May 2009. I am one of those people that has trouble with infection in the presence of asthma.
Drop me a line and let me know what your thoughts are. I won't continue my calling if I know for sure someone is going to pick it up. Also, let me know if anything may be posted on a patient website concerning this. I participate in http://www.stemcellpioneers.com and http://www.copdliving.com There are many COPD patients involed with these sites and the medical community hasn't offered them much.
Sincerely,
Zee