Monday, February 22, 2010

Aprea starts Phase I study with APR-246

A patient who did not respond to treatment has entered the following clinical trial, I thought it might be of interest and have posted the link.

Aprea starts Phase I study with APR-246

The MPA approval, on April 8, 2009, for Aprea to start the Phase I study meant that the company could go ahead and start the study with their first CD (APR-246, also denoted PRIMA-1MET in the literature). Patients started to be included in June 2009.

This study, APR-246-01, is a first-in-man, multi-center, open label, non-comparative, phase I, dose escalating study of APR-246 infusions in patients with refractory hematologic malignancies or prostate carcinoma.

During the treatment phase, the patient will receive APR-246 treatment on four consecutive days as a 2-hour daily intravenous infusion. The treatment phase will be followed by a 17 days follow-up phase to reveal any late adverse effects. The patient’s total duration in the study will be 21 days.

2 comments:

Anonymous said...

Dear Mark,
Great that you published the information I sent to you. The European Medicines Agency recommendds Orphan Drug Designation for APR-246 in AML(Pressrelease, February 18: http://www.presskontakt.se/pressreleaser/visa/pressrelease/209415/aprea-the-european/FA64855B-B830-0840-4936-86C2BB83AA85). My father in law has T-PLL and he will soon enter the clinical trial. I hope APR-246 can help him, but if not - I hope that his participation will lead the research and development forward.
Best regards from Sweden

Elaine said...

Hi, I don't know if anyone still reads this blog, but my mum was diagnosed with TPLL december 09 (an xmas we will never forget). Her WBC was 700 and she stared on campath - that failed - she then had steroids with it - got told it looked like it was working, then finally we were told it wasnt. She has just stared on penstatin(sp?) which she is having weekly, plus campath 3 x wk. the consultant is keeping everything crossed - she asked if it didnt work - he said it was a conversation he did not want to have with her. When i google all i find is "rare, aggressive disease with average lifespan of 7.5mths". i know i have to be hopeful that the treatment will work, and that then they find a match for a bone marrow transplant, but at the moment, all i see is a black hole with her sinking further in it - she is only 63 - otherwise fit and healthy. am in the Uk. mum seen by christies manchester who are liaising with royal marsden in london.