Colin,at the first AGM with the new Board (29/11/2011)many questions were raised from the floor,one such question was whether Xtoll can be reformulated for greater efficacy.The answer was that it already was with a Us company and would take at least 6 months to complete.There is no specific reference to that question. However on 12/12/2012 CBio released a question and answer fact sheet in relation to questions asked at the meeting and I have reproduced a paragraph below which states that continued formulation is required.
An extract below from questions raised by Share Holders
In recent weeks the company has been made aware of queries of shareholders relating to the development program for XToll and the rheumatoid arthritis clinical trial. We take this opportunity to respond. 1 Why didn’t the company dose higher in the IIa RA clinical trial? Would that not have improved the result? There are two important points to be made. First, a higher dose arm was not possible at the time of the commencement of the IIa RA trial, as at the time drug formulation and stability studies limited the upper concentration of the drug. There are also regulatory restrictions to increasing dose-ranges too rapidly, without detailed studies to confirm safety. Significant work has been put into formulation and characterisation studies since the commencement of the RA trial. XToll is now able to be concentrated to 200mg/mL with good stability over a limited period, however continued formulation refinement is required. This process of continued improvement is standard in biological drug development. Second, at the doses tested, XToll has exhibited good tolerability and safety but, so far, insufficient efficacy in the treatment of rheumatoid arthritis. To suggest that a higher dose may be equally well tolerated and show good efficacy is a scientifically unsubstantiated speculation. The effects at higher doses, particularly over 12 weeks of treatment, are unknown. Didn’t any patients do well on the trial? Why doesn’t the company release that information
CBZ Price at posting:
6.5¢ Sentiment: Hold Disclosure: Held
