Apollo’s Trial Success - Needle-free Drug Delivery
SYDNEY, Australia, Aug. 6, 2007--Apollo Life Sciences today announced positive results from independent trials of its transdermal (across the skin) drug delivery technology, Intradel™.
Apollo CEO John Priest said Intradel™ is a breakthrough in the delivery of large water-soluble molecules across the dermis (skin) into sub-dermal and muscle layers – without the use of needles.
"Incorporating the non-invasive technology of Intradel™ into a topical lotion formula allows a ‘transdermal vehicle’ to carry a large range of active water-soluble molecules, such as proteins or natural botanical ingredients, across the skin."
Mr Priest said that Apollo’s Intradel™ technology has a wide and varied range of applications. "The technology acts as a vehicle to carry active molecules for the treatment of a range of serious skin and joint diseases such as psoriasis, arthritis and detection and treatment for skin cancers. It can also be used in over-the-counter wrinkle and cellulite treatments for the global skincare market."
The latest trial, of an anti-wrinkle serum, showed that Apollo’s Intradel™ technology successfully delivered FDA-approved active ingredients across the skin. This reduced the visual appearance of fine lines and wrinkles around the eyes of test volunteers.
CEO John Staton of Dermatest, the Sydney-based sunscreen and skincare product evaluation company that conducted the trial, said "the immediate effects of Apollo’s anti-wrinkle serum were comparable to those obtained after one month’s treatment with similar products".
Dermatest has now commenced a more intensive four-week study of Apollo’s anti-wrinkle serum. Results of this study are due in late August.
Dermatest is also midway through an eight-week trial of Apollo’s cellulite serum. To date, 90 per cent of test participants have noticed a visible reduction in the appearance of cellulite, while 100 per cent have experienced an improvement in skin firmness, smoothness and tightness.
According to Mr Priest, the positive trial results show that Apollo’s Intradel™ technology can capitalise on the large and growing global skincare market. In 2005, the global skincare products market was worth an estimated US$38.3 billion.
"With future positive trial results, Apollo expects to launch its Intradel™ technology in Australian retail stores later this year and in the US in 2008," Mr Priest said.
While the core function of Intradel™ is to meet the worldwide demand for needle-free drug delivery systems, the technology’s versatility has allowed Apollo to move into areas such as skincare products that require a lower barrier to market entry compared to therapeutic drugs.
"The adaptability of Intradel™ will allow Apollo to generate cash flow while the company progresses clinical trials of its needle-free therapeutic drugs that are designed to treat diseases such as psoriasis and arthritis," said Mr Priest.
Apollo’s Intradel™ technology is used in the delivery of Apollo’s topical tumour necrosis factor (TNF) blocker for the treatment of psoriasis. Phase 2 trials of Apollo’s TNF blocker are scheduled later this year.
"By integrating Intradel™ technology with our TNF blocker, Apollo is well-placed to take advantage of the worldwide demand for psoriasis treatments; estimated at US$5 billion per annum in 2005," said Mr Priest.
For more information: For media enquiries: Apollo CEO, John Priest Andrew Huckel Apollo Life Sciences Wilkinson Media 02 9310 1800 / 0419 246 356 02 8001 8888 / 0402 822 622
About Intradel™
Apollo's non-invasive transdermal carrier is based on a proprietary formulation that is able to deliver large water-soluble proteins across the skin into the surrounding dermal and hypo-dermal layers.
Intradel™ can deliver a wide range of molecules in terms of size and water or oil solubility. Drugs up to antibody size have been identified as potential candidates for the technology, including leading biopharmaceuticals that have previously been considered unsuitable for transdermal delivery. Apollo’s transdermal technology opens up the possibility of treating a range of diseases with topical applications.
About the human studies
Eye wrinkle reduction trial: The biophysical effects of the topically applied product were evaluated in six test subjects with mild to moderate fine lines in the crow’s foot area. They were instructed to apply the product in the morning and evening to the eye area. Changes in skin roughness and wrinkle depth were measured from silicone replicas made of the eye area at each of four time points: before application of product, immediately after a single application of the product (10 minutes) at 2 hours after product application and 1 week (4 to 8 hours after that day’s product application). For each of the four time points, the height of wrinkles was measured from a single silicone replica. Participants also completed a self assessment survey. Five of the six subjects completed the trial.
Cellulite reduction study: The physical effects of the product topically applied morning and night are evaluated at several time intervals over an eight-week period by a combination of qualitative measures including photography, participant surveys and independent technical ratings.
About Dermatest Pty Ltd
Dermatest is a Sydney-based sunscreen and skin care product evaluation facility. The company conducts a range of skin product safety and efficacy tests, including evaluation of the effect of product on skin surface profile.
About Apollo Life Sciences Limited
Apollo Life Sciences (ASX: AOP) is an Australian-based biotechnology company with core expertise in the structure and function of proteins. Apollo’s extensive library of over 90 human proteins is a rich source of candidate biopharmaceuticals such as the anti-TNF ALS-00T2 used for psoriasis treatment. Apollo’s library of proteins is generating early sales revenues from research and diagnostic testing.
Apollo has leveraged its accumulated knowledge of proteins to improve drug delivery methods of accepted large molecule drugs like insulin that have previously been administered by injection. The Company has developed and patented two major needle-free technologies, the oral Oradel™ platform and the transdermal Intradel™ platform, designed to eliminate patients’ discomfort, improve effectiveness and lower the cost of therapeutics in major biopharmaceutical markets. Apollo’s lead therapeutic candidates are oral insulin and an oral and topical TNF blocker.
http://www.apollolifesciences.com/
