Lets try and put this trial into perspective with regards to all the crap that has been posted
No 1 TITLE OF THE TRIAL A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly
Let’s define the title with regards a clinical trial
No 1 SAFETY
Determine a safe dosage range and identify side effects.
No 2 TOLERABILATY
Refers to the degree to which overt adverse effects of a drug can be tolerated by a patient
No 3 PHARMAKINETICS
1.The process by which a drug is absorbed, distributed, metabolized, and eliminated by the body.
2. The study of this process.
No 4 EFFICACY
The ability to produce a desired or intended result:
Ok so lets deal with No 1 First
No 1 SAFETY
The dosage for the trial was
1 x 200mg weekly after week
1 & 2 x 200mg weekly after week 1
So the designated dosing for the trial was deemed SAFE AS No subject withdrew or was withdrawn for safety reasons related to treatment with ATL1103.
PASS WITHIN THE DEFINITION OF THE TRIAL
No 2 TOLERABILITY ATL1103
was considered generally well tolerated at the doses used in the study
PASS WITHIN THE DEFINITION OF THE TRIAL
No 3 PHARMAKINETICS
Pharmacokinetic data and MRI data is not yet available
No4 EFFICACY
The Phase II trial met its primary efficacy endpoint showing a statistically significant average reduction in the serum insulin-like growth factor-I (sIGF-I) levels of 26% from baseline (P<0.0001) at week 14 (one week past the last dose) at the 400mg per week dose tested. All patients treated with 400mg per week of ATL1103 had a reduction in sIGF-I levels from baseline at week 14. Greater reductions in sIGF-I were observed in patients who had lower body weights and thereby received a relatively higher dose per kg bodyweight (correlation of P=0.0001) with the patients who received >5.5 mg/kg per week showing a 36% average reduction in their sIGF-I levels
PASS WITHIN THE DEFINITION OF THE TRIAL
PLAIN AND SIMPLE THIS TRIAL WAS A SUCCESS
The trial was never set out for maximum results
Now the trial is complete we have a benchmark within which to work
AND that BENCHMARK
has been deemed safe with positive results in the reduction of sIGF-I
That BENCHMARK
has also enabled the scientists through this trial to observe that ATL1103 could be deemed tolerable at larger doses
HENCE THE FOLLOWING REMARKS
The results achieved in this Phase II trial suggest ATL1103 with appropriate dose adjustment should be capable of achieving disease control in a significant proportion of patients with acromegaly. ATL1103’s profile as a potentially efficacious and well tolerated conveniently dosed therapy strongly supports its move into Phase III stage of development.
PLEASE NOTE THESE WORDS
With appropriate dose adjustment should be capable of achieving DISEASE CONTROL in a significant proportion of patients with acromegaly.
AND MAKES SENSE TO ME BEFORE GOING INTO PHASE 3
Preparation for Phase III Development As previously reported,
The Company plans to conduct a small study at a higher dose than 400 mg per week for potential use in a Phase III clinical trial.
AGAIN this trial was not aimed primarily at maximising the the reduction of sIGF-I
This Trial has been a GREAT SUCCESS in that it has returned COMMERCIALY VIABLE RESULTS with no adverse effects to make mention off.
BUT
is yet to be tested to its full POTENTIAL.
I purchased more today.
THIS IS MONEY IN THE BANK PLUS SOME
I spoke with Mark today to congratulate him on the success of the trial.
As a holder yes I am disappointed with the Sp I thought we may have reached and held Kevins 20c ( If only to get rid of him ) LOL
But I have said in the past as others have said I doubt we will see true value until the partner has signed on the dotted line which is a shame but I guess that’s the markets for you.
Anyway enough from me
GREAT RESULT Congratulations once more Mark to yourself and the team that is
ANP
GO ANP
ANP Price at posting:
15.0¢ Sentiment: Buy Disclosure: Held
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