Hello all.
We are ready for baseball playoffs here in the Thimmes household. Ben is rooting for the Rays and the Brewers, so we'll see how that goes.
We are back into school mode, so I work 3 days a week. Ben's mom is with him each morning and helps us a lot. Actually, many people help us during the week. However, as I get bigger and bigger, I also get more tired, so we may need to add to our help soon. And who knows what will happen when baby gets here! Sophie's excited for the baby. She says she has one in her belly too:
The good news is that Ben finally got his communication device!! Hooray!! He is talking up a storm. If you haven't seen it yet, stop by, and he'll tell you all about it. It operates from eye movement alone, which is pretty high tech. It is nice to hear him again. Of course, it's a little slower than regular talking, but as long as you're patient, you can talk with him about anything you want. We're also hoping to get it linked up to the internet soon, so maybe he'll be sending out e-mails again. Keep your fingers crossed.
The van is still going! It is such a relief to be able to go where you want when you want. I never knew how much I took that for granted before.
Last weekend we had the ALS walk, which was very nice. The weather was good, especially afterwards when we went to a nearby park. Lots of friends and family came, and we had a good time. Thanks for coming, and mark your calendars for next year.
Feel free to post a comment on this blog. We love to see who is reading!
Love you all.
Sarah, Ben, Soph, (and baby)
4 comments:
I am reading!! Thanks for the update, Red! I need blogging lessons from you. I suck. Ben, so glad you finally have your device!! Have any movie clips loaded on it yet?
Love you guys!
Hey Guys,
Thanks for the update. Me and Weston enjoyed getting out at the walk as well. we need to come over and check out the device. I'll be in touch.
Cat
Next time I'm home I'll expect to hear Ben singing happy birthday to me. Then we'll do some tequila shots and debate how much money CC Sabathia is worth, and remark thoughtfully on the capitol (?) gains tax, and how funny it is that now even Sophie is admitting she has a weight problem, and other various irrelevancies.
We're friends of Ryan-my brother had ALS, thought you guys might be interested in this information if you haven't seen it!
FDA TO ALLOW COMPASSIONATE USE OF INSMED'S IPLEX FOR ALS
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The Food and Drug Administration will allow patients with amyotrophic lateral
sclerosis (ALS) to have access to Insmed Inc.'s Iplex (mecasermin rinfabate
[rDNA origin]), a treatment for growth failure, under an Investigational New
Drug (IND) application.
The agency said it had received numerous single-patient IND requests from
physicians to allow compassionate use of the drug for named patients with ALS,
but it had previously denied those requests because it was not aware of any data
suggesting that Iplex was beneficial in the treatment of ALS.
As requests for access to the drug continued to be made, the FDA learned that
Iplex had been made available to more than 100 patients with ALS in Italy via a
court order. The agency requested and received data pertaining to these patients
from its Italian counterpart. According to the FDA, although the data were not
sufficient to determine the drug's efficacy in this indication, no serious,
immediate drug-related toxicities were apparent.
Because the supply of the drug is limited, the regulatory agency will restrict
its use to single-patient INDs requesting compassionate use of Iplex for the
treatment of named patients with ALS that were received and date-stamped by the
FDA's document room before the close of business on March 6, 2009.
Insmed will use the remaining supply of Iplex to conduct a clinical trial under
an IND; in the trial, other patients with ALS will be randomized to receive the
drug through a lottery system.
Iplex is approved for the treatment of growth failure in children with severe
primary insulin-like growth factor 1 deficiency or with growth hormone gene
deletion who have developed neutralizing antibodies to growth hormone, but the
FDA noted that it is not currently marketed in the United States because of a
patent-related court order.
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NEURALSTEM'S SPINAL CORD STEM CELL TRIAL PUT ON HOLD
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The Food and Drug Administration placed Neuralstem Inc.'s spinal cord stem cell
trial for amyotrophic lateral sclerosis (ALS) on hold pending additional
information and several modifications.
Neuralstem explained that its technology allows for neural stem cells of the
human brain and spinal cord to be produced in commercial quantities and
differentiated into mature, physiologically relevant human neurons and glia. The
firm is targeting several major central nervous system diseases with these
cells, including ALS.
"The FDA has presented us with their review of our entire Investigational New
Drug application," explained Richard Garr, Neuralstem's chief executive officer.
"They have asked for some additional information regarding our product
manufacturing process and preclinical studies, as well as our novel clinical
delivery injection device and technique."
Neuralstem believes it can quickly provide this information.
According to Garr, the agency also requested various changes to the study
protocol and eligibility criteria for patients in the trial, as well as slight
modifications to the timing of the surgeries. He said that the firm is
evaluating these changes and will respond.
"The agency had extensive 'non-hold' comments, requests for information and
recommendations. These primarily concerned issues that will need to be addressed
for final product manufacturing and testing," he added. The firm is evaluating
these comments and recommendations so it can reach an agreement and move forward
with the trial.
So far, preclinical results have shown that the cells extended the life of rats
with ALS and reversed paralysis in rats with ischemic spastic paraplegia.
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