(.>_<) !!!! Read this for newbies ~~~~~ DYOR =? go to page 6 of 8 of link at bottom ~~~~ 2 trails under way at same time for ATL1103 =Mattel Children?s Hospital at UCLA Los Angeles, CA 90095 /Austin Hospital, Heidelberg, Victoria
>>>>> DYOR a must <<<<<<
ANTISENSE THERAPEUTICS Antisense says it has begun dosing human subjects in its phase I trial of the growth hormone receptor (GHr targeting drug ATL1103.Antisense said the 36-subject, randomized, placebo-controlled, double-blind study of single ascending doses and multiple doses of ATL1103 in healthy adult male subjects aged between 18 and 45 years was being run by Nucleus Network at their dedicated clinical trial unit co-located at the Austin Hospital, Heidelberg, Victoria.
The company said the primary objective was to assess the safety, tolerability and pharmacokinetics of ATL1103 administered by subcutaneous injection, with a secondary, objective to obtain key data on the effect of ATL1103 on IGF-I levels in the blood of the trial subjects.
Antisense said reducing elevated levels of serum IGF-I to normal was the therapeutic endpoint in the treatment of the growth disorder acromegaly, and reducing the effects of IGF-I had a potential role in the treatment of diabetic retinopathy, nephropathy and certain forms of cancer.
The company said the Royal Children?s Hospital?s director of endocrinology Prof George Werther, an Antisense non-executive director, would be a member of the data monitoring committee.
Antisense said University of California Los Angeles? Prof Shlomo Melmed would also consult on the trial.
Prof Melmed said there was a need for improved therapies for treatment of the growth disorder, acromegaly.
?ATL1103?s effects in suppressing serum IGF-I levels in previous studies comits potential safety advantages over existing treatments and more convenient dosing regimen make ATL1103 an excellent clinical candidate,? Prof Melmed said.
The company said dosing was expected to be completed before the end of the year with results early next year.
Antisense said would conduct its ATL1103 cancer experimental program in parallel with the phase I acromegaly clinical trial, established with Mattel Children?s Hospital at UCLA head of diabetes and endocrinology Dr Pinchas Cohen.
The company said Prof Cohen co-authored a study that found that patients with Laron syndrome who carry a genetic mutation that silences their growth hormone receptor thereby having depressed levels of growth hormone receptor and IGF-I, were protected from developing cancer.
Antisense said Prof Cohen?s team will look at ATL1103?s effect on exploratory markers of cellular activity relevant tocancer from the subjects who received multiple doses, to assist in determining the potential of ATL1103 in the new application of preventing certain forms of cancer in high risk individuals.
