[Nan Cyclist]

http://weill.cornell.edu/#id=30

This article just appeared in the Cornell Weill journal. I am just so hopeful.

[Conductor71]

Originally Posted by Nan Cyclist

http://weill.cornell.edu/#id=30

This article just appeared in the Cornell Weill journal. I am just so hopeful.

Nan,

We have been sharing Neurologix updates here, and I am really hopeful too. I see this as easily supplanting DBS. It is interesting to note that Medtronic, the co, responsible for DBS design, plays a part in this treatment. It's almost as if they know Neurologix is really offering a superior treatment and are wanting to be a part of the deal.

Most articles I have read give very little detail on the procedure itself, but this article explains the newer bedside delivery innovation and the sham procedure. I have wondered how a sham surgery is performed; this is the first article I have read that clearly explains the sham surgery details. I have also read that the real deal will be given to the control group at the end of the study if they so opt to have it.

One of the lead researchers is my former neuro Dr. Lewitt, so I may be calling to see if I qualify for further trials.

Thanks for the extras!

Laura




Laura

[paula_w]

There's that figure again.....1,5 million. We know there are more. This is very very encouraging. Does anyone know about phase 3? This is a non dopaminergic trial and it has made it past phase 2 .....yowsah!

"This is great news for the 1.5 million Americans living with Parkinson's disease," adds Dr. During, who is the co-inventor, with Dr. Kaplitt, of the gene therapy procedure. "Since this is also the first gene therapy study for a neurological disease to achieve success in a rigorous randomized, double-blind design compared with a sham group, this is also a crucial step forward toward finally bringing gene therapy into clinical practice for patients with debilitating brain disorders."

Now we also need to pass S425 to get that registry.

[Conductor71]

Originally Posted by paula_w

There's that figure again.....1,5 million. We know there are more. This is very very encouraging. Does anyone know about phase 3? This is a non dopaminergic trial and it has made it past phase 2 .....yowsah!

"This is great news for the 1.5 million Americans living with Parkinson's disease," adds Dr. During, who is the co-inventor, with Dr. Kaplitt, of the gene therapy procedure. "Since this is also the first gene therapy study for a neurological disease to achieve success in a rigorous randomized, double-blind design compared with a sham group, this is also a crucial step forward toward finally bringing gene therapy into clinical practice for patients with debilitating brain disorders."

Now we also need to pass S425 to get that registry.

Paula,

My recent former neuro, Dr. Lewitt, is one of the lead researchers involved in this phase, and since it is happening so nearby I am thinking of trying it if I qualify. I plan on calling his office tomorrow and hopefully I can find out if there is a Phase 3 in the works. Last I read, Neurologix was having difficulty securing capital needed for mores trials, but hopefully this has been resolved.

My question is it looks like we would still need meds. I haven't read of any med reduction as result. Maybe I have overlooked that info?

Laura

[soccertese]

i'd like to know how the phase 1 patients are doing.
they only received an implant on 1 side of brain but it would be nice to know if they were still getting symptom improvement.

http://www.webmd.com/parkinsons-dise...-seems-to-work


http://query.nytimes.com/gst/fullpag...pagewanted=all
They were more hopeful back then, about the disease and Mr. Klein's ability to work. In 2003, he was featured in news media around the world -- including the front page of The New York Times -- when he became the first human to receive gene therapy for Parkinson's. His handsome portrait, taken during a nine-hour photo shoot, was displayed in full-page ads extolling NewYork-Presbyterian Hospital's cutting-edge medical care.

But the therapy did not stop the Parkinson's. Mr. Klein, now 60, is still not able to work. He has deteriorated mentally. ''I don't remember a lot,'' he said. And physically. ''I freeze in the middle of things.

----------------------------------
just providing some more info.

[soccertese]

Originally Posted by Conductor71

Paula,

My recent former neuro, Dr. Lewitt, is one of the lead researchers involved in this phase, and since it is happening so nearby I am thinking of trying it if I qualify. I plan on calling his office tomorrow and hopefully I can find out if there is a Phase 3 in the works. Last I read, Neurologix was having difficulty securing capital needed for mores trials, but hopefully this has been resolved.

My question is it looks like we would still need meds. I haven't read of any med reduction as result. Maybe I have overlooked that info?

Laura

they got a 7mill bridge loan, the results have been out for 6 months, the trial started over a year ago, i'm sure they haven't been waiting for this paper to try to secure funding or a buyout offer.
from an SEC document:
In June 2010, the Company announced positive results from its Phase 2 clinical trial for the treatment of advanced Parkinson’s disease. Trial participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery. In the trial, this benefit was seen at one month and continued virtually unchanged throughout the six month blinded study period. The Phase 2 results, which were published in an online-first edition of The Lancet Neurology on March 17, 2011, also demonstrated a positive safety profile for NLX-P101, with no serious adverse events related to the gene transfer or surgical procedure reported in the 12-month period following the surgical procedures. In accordance with the trial’s protocol, treated participants will continue to be monitored for safety for a five-year period following their surgical procedures.

Those Control Participants who continue to meet all entry, medical and surgical criteria for the trial will be offered the opportunity to participate in the open-label arm of the trial to receive a bilateral infusion of the gene-based treatment. Subject to adequate funding, the Company expects to commence the open-label arm of the trial in the second or third quarter of the 2011 fiscal year. (See Item 1A – “Risk Factors – The Company Does Not Have Sufficient Funds to Continue its Operations in the Long Run or to Commercialize its Product Candidates,” See Item 7 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Plan of Operation” and Item 7 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources”).

The Company is currently taking steps to move toward a pivotal trial for the treatment of Parkinson’s disease, and hopes to be in a position to file its protocol with the FDA in 2011. The Company’s conduct of such a trial will require, among other things, approval by the FDA and adequate funding. Currently, the Company estimates that all surgeries conducted in the pivotal trial could be completed in the first half of 2014 and the estimated total direct costs to reach that milestone are expected to be between $30 million and $40 million. (See Item 1A – “Risk Factors” and Item 7 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations”).
http://www.sec.gov/Archives/edgar/da...04676e10vk.htm

[Conductor71]

Originally Posted by soccertese

they got a 7mill bridge loan, the results have been out for 6 months, the trial started over a year ago, i'm sure they haven't been waiting for this paper to try to secure funding or a buyout offer.
from an SEC document

I'll admit to being ignorant when it comes to capital venture and raising the millions needed to jump through all the FDA hoops. I am merely summing up the financials for this start up last I read which was near the end of 2010. I do have documentation on that. Anyway, regarding a buyout, it looks like Medtronic was a contender which is interesting given their position on DBS.

Is Medtronic Acquisition of Neurologix in the cards?

and this on state of finance for Neurologix as of 12/10 from same website:


Nearly running out of cash for operations, the $7 million infusion announced will buy some additional time for the company to try to attract additional, and more significant financial resources to try to bring it's products forward. As I have previously noted, clinical trials, especially Phase III efforts, are very expensive to run. Where will the money come from for the reported Phase III effort in Parkinson's disease (PD) that NRGX is proposing? When will the scientific community be allowed peer-review of the Phase II study results announced this last October (data not yet published)? Where will funding come from to develop the temporal lobe epilepsy and depression treatments the company is trying to bring forward? This may be the time that the lead product, gene therapy for PD (AAV2-GAD to the subthalamic nucleus) takes the bulk of the financing in an attempt to move it into the marketplace.

Soccertese, I appreciate you correcting my post if I misinformed anyone, but I don't think I have based on what is still being reported as their financial status quo. Please explain how we are saying different things here; like I said, not so great with financials, so if I am being obtuse fill us all in but not with a quote from the SEC. I need it in plain English, please.

Thanks,

Laura

[soccertese]

Originally Posted by Conductor71

I'll admit to being ignorant when it comes to capital venture and raising the millions needed to jump through all the FDA hoops. I am merely summing up the financials for this start up last I read which was near the end of 2010. I do have documentation on that. Anyway, regarding a buyout, it looks like Medtronic was a contender which is interesting given their position on DBS.

Is Medtronic Acquisition of Neurologix in the cards?

and this on state of finance for Neurologix as of 12/10 from same website:


Nearly running out of cash for operations, the $7 million infusion announced will buy some additional time for the company to try to attract additional, and more significant financial resources to try to bring it's products forward. As I have previously noted, clinical trials, especially Phase III efforts, are very expensive to run. Where will the money come from for the reported Phase III effort in Parkinson's disease (PD) that NRGX is proposing? When will the scientific community be allowed peer-review of the Phase II study results announced this last October (data not yet published)? Where will funding come from to develop the temporal lobe epilepsy and depression treatments the company is trying to bring forward? This may be the time that the lead product, gene therapy for PD (AAV2-GAD to the subthalamic nucleus) takes the bulk of the financing in an attempt to move it into the marketplace.

Soccertese, I appreciate you correcting my post if I misinformed anyone, but I don't think I have based on what is still being reported as their financial status quo. Please explain how we are saying different things here; like I said, not so great with financials, so if I am being obtuse fill us all in but not with a quote from the SEC. I need it in plain English, please.

Thanks,

Laura

really just adding my 2 cents, not "correcting" you. the link was to the SEC site for company generated filings required by the SEC, in this case company's annual report, this was not a SEC doc. just a convenient place to research info for any publicly traded company and companies that invest in them.

nothing complicated here, they need money.