2 replies to this topic

[mcferguson]

repost from mj23 on carecure:

"Geron Reports on Phase 1 Spinal Cord Injury Trial – 042811


Today, Geron reported results for its first quarter financials. Of course my reason for listening to the report was to pull out the relevant information relating to their phase 1 trial using embryonic stem cell derived neural cells to regenerate the spinal cord in humans.

Here’s some highlights from the report that pertain to the spinal cord injury trial.

Interim CEO David Greenwood reported, “Turning to our cell therapy programs. We presented new data on three of our four programs. Starting with the program in the clinic, GRNOPC1 oligodendrocyte progenitors. We presented safety data for the phase 1 clinical trial in spinal cord injury. In short, the first patient in the trial completed the 180 day follow-up visit in April with a clean safety profile. There were no serious adverse events. There were no adverse events related to either the injection procedure, or the cells. The two mild adverse events that were reported were related to the immunosuppressive drug Tacrolimus; Nausea and low magnesium count, which are both known side effects related to Tacrolimus, and were minor. There was no significant changes in the patient’s neurological status. Repeat MRIs showed an absence of a lesion cavity in the spinal cord, which is important because it is consistent with what we saw with our histology we saw in our animal studies. Finally, there is no evidence of immune rejection through day 90, which is 30 days post withdrawal of the immunosuppressive drug. This is a very good safety profile. Probably the best safety profile we could hope for. So, we are very pleased. To date, we have enrolled one subject in this trial. We have tightly constrained inclusion and exclusion criteria, which are part of a very conservative approach to safety with regard to design of the trial. We are addressing the enrollment challenges right now. We have five clinical sites open for enrollment, and we are working to open two additional sites. We have also expanded our recruitment area around each site. The entire eastern half of the US, as well as California is now within the catchsmith? area. We have discussions ongoing with the FDA to evaluate certain eligibility criteria that we know limit enrollment. We would like to expand our inclusion criteria to include patients with a neurological level at T-11 . Which is a substantial percentage of thoracic injuries we also proposed a reduced stagger between subjects. The next opportunity to present data from the phase 1 trial will be at the joint international spinal cord society and American spinal cord cord injury meeting in Washington DC. Which will be held in June.”

This is their lead program, and they want to move ahead as fast as possible with each stage; moving to cervical complete injuries, and then incompletes. Of course they’ll move with safety as a first issue.

Specific attention has been made to completing enrollment in the trial at their designated sites. With five sites up and running, they’re expecting some of their highest enrolling sites to come on board in May. They’ve been focusing a lot of attention on opening their sites. They’ve also been working on increasing the referrals to the sites. They’re really looking at lowering restrictions they had earlier on the catchsmiths? around a particular site. They were looking at having patients live around two hours from the site. They have now opened up that considerably. There really looking at increasing referrals to each of the individual sites, and broadening the area in which they cover. Also, increasing the study to cover T-11 injuries could possibly increase enrollments 2 to 3 fold. Also, the stagger between enrolling patients is 30 days, and they are talking with the FDA to decrease that.

They are also working on escalating the dose that each patient gets.

So far so good. There are no shortcuts."

[brockit79]

thanks for this, it renews my hope and helps to keep me positive.

broc

[Tetracyclone]

It surprised me that Geron's stock price fell on that day. Not what had been anticipated. i fear some think the company will go belly up, at this pace.