I do not know if a review has been issued yet, my link is to a review of the webcast by "interested parties".

I thought any information from this meeting would be of interest, (due to its potential impact on some of our trials, (Neurologix, Ceregene, Oxford Biomedica)) so I posted this review of the webcast by chaps who seem to know their stuff.

All gets a bit medical for me however the consensus seems to be that the patient who died had the illness prior to the trial. There appears to be no evidence implicating the AAV vector although work is still ongoing to confirm this. An informal summary lifted from the same message board is reproduced below:

"(1) This patient had moderate RA. She had prior surgery to correct deformities of both feet, and was getting injections of steroids into her knees despite being on maximal medical regimens to control her symptoms. This suggests to me she had pretty severe symptoms.

(2) She signed the informed consent following discussions with her husband and her physician. She had TWO WEEKS during which time she could have changed her mind about the trial. She chose to stay in the study. I feel certain she did not expect the treatment to do her any harm.

(3) The immediate cause of death is still being investigated and no formal autopsy result was released. However, she died of a consumptive coagulopathy due to a large retroperitoneal hematoma that rapsidly progressed over a matter of days. She was being given massive doses of blood products to try to correct the coagulopathy, but they could not correct it. She developed hepatic failure, and progressive end organ failure. Surgeons evaluated her during her course at University of Chicago but felt there was nothing they could do.

(4) She had a mild infection of some sort just prior to the injection of the AAV into her right knee. Serology taken the day of her injection showed evidence of a low grade Histo antigen in her blood. That does not mean she had Histo, but in the face of a negative blood test two months prior it is something suggestive. The physician who reviewed that information felt she PROBABLY had Histo prior to the second injection.

(5) It is not clear to me what caused the progressive consumptive coagulopathy. Infections can do this. A massive retroperitoneal bleed that becomes progressive can do this. As she bled more and more, attempts to transfuse her essentially put most of the blood products into the hematoma. Her liver began to fail, probably due to hypotension and hypoperfusion. The Histo in her liver (there by histology) might have contributed, but the liver biopsy on presentation to the Univ Chicago did not show massive liver necrosis. Her clinical course deteriorated so quickly there was little they could have done during her last few days at University of Chicago.

(6) Preliminary data from the patients in the Phase I study show that even in the face of the high dose of AAV, you cannot find serologic evidence of expression outside the joint. Her PCR studies are still pending at this time.

My impression based on the preliminary autopsy and review of the information presented today : It will be very hard to link the injection of this AAV to her eventual death. You would have to propose that this somehow predisposed her to a consumptive coagulopathy (possibly due to an infection) and caused the retroperitoneal bleed. It will be unlikely that any extra-articular spread of the AAV (if it occurred) could have further immunosuppressed here. That seemed unlikely to most of the physicians in the room. I'm sure many have an opinion, but most seemed perplexed by the clinical course".


This is not issued from a formal source and if I find a "formal" report I will issue ASAP.

Hope this helps, take care,
Neil.