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| Phase I trial of Apollo's Oradel® insulin tablet to begin in mid-2008 |
Nanoparticles made 15,000 times
smaller than actual size | According to Apollo CEO John Priest, for a company that only listed in June 2005, Apollo has achieved some significant milestones in the development of an oral insulin tablet.
"If you look around the world today there are only a handful of companies that are approaching or conducting Phase I or II trials for an oral insulin tablet. Apollo plans to enter the Phase I trial of its Oradel insulin tablet in mid-2008 – the only company in Australia to reach this stage of development," said Mr Priest.
Apollo's scientists will be undertaking the following studies in preparation for and during the Phase I trial in mid-2008:
Optimise the formulation of Oradel nanoparticles
Diabetics commonly suffer from gastroparesis a condition consisting of a partial paralysis of the stomach, resulting in food remaining in the stomach for a longer period of time. Therefore, Apollo's insulin-loaded Oradel nanoparticles must be able to withstand prolonged periods being subjected to the stomach's digestive enzymes and acids.
Apollo's Head of Drug Delivery Dr Michael Luke said the company will continue optimising the formulation of Oradel nanoparticles to ensure they remain intact under even the harshest conditions of the human stomach.
Determination of vitamin B12 uptake
Each person has a different capacity to absorb vitamin B12 – a process that is partially stimulated by the digestion of food in the stomach.
Apollo has initiated studies to determine the optimal conditions needed in the stomach to induce the maximum uptake of vitamin B12 (and hence induce the maximum uptake of Apollo's vitamin B12 coated Oradel nanoparticles which contain entrapped insulin molecules).
"The studies will allow Apollo to find the optimum times before and after meals to administer Oradel insulin and the most effective dosage rates," said Dr Luke.
Preclinical pharmacokinetic studies
Pharmacokinetic (PK) studies are performed to examine the absorption, distribution, metabolism, and excretion of a drug under development. Apollo will use the data obtained from its PK studies to help design and conduct clinical trials. For example, Apollo's PK studies on animals will help determine the dose-ranging of Oradel insulin to be administered to Phase I and II volunteers.
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