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ASX Announcement 30 April, 2007
Australian bio-discovery company Apollo Life Sciences announces needle free vaccine
Apollo Life Sciences (ASX:AOP) today announced it has successfully delivered a vaccine without needles, by applying it topically to the skin of mice using the company’s transdermal delivery technology. The technology could spell the end of injections for tetanus, flu and many other vaccines, according to Apollo’s CEO, John Priest.
The studies showed that tetanus toxoid delivered by topical application to the skin using Apollo’s formulation technology was more effective at generating an antibody response than injection of tetanus toxoid.
Standard vaccines are widely used to protect against childhood diseases such as diphtheria and whooping cough, and for global epidemics such as bird flu, and are usually injected.
Mr Priest said the technology had a second major application as a platform for transdermal delivery of a topical TNF blocker. “We believe our technology will make a big difference, and so we have fast tracked its development. Both applications have the potential to dramatically reduce the cost of drugs currently delivered other ways, including infusions and injections.
“Apollo’s topical vaccinations would potentially transform life for patients dependent on injectables by removing the pain and fear of standard vaccinations,” said Mr Priest.
“Topical vaccines could also save health systems substantial amounts of money. This approach will avoid needle stick injuries and can be delivered conveniently and easily without medical intervention. Topical vaccines also offer the benefits of being easier and quicker to deploy and cheaper and easier to store than conventional injectable vaccines,” Mr Priest said.
The current market for vaccines is worth approximately US$9 billion globally with a 10-12% annual growth rate.
Several animal studies were conducted comparing the antibody response generated to tetanus toxoid by standard injection with topical administration using Apollo’s formulation technology. Animals each received three rounds of vaccination, and blood samples were taken 14 days post vaccination and assessed for antibody development to tetanus toxoid. Stimulation of cellular immunity, which is an important arm of the immune response, was also measured by delayed type hypersensitivity.
“The early tests show great promise for vaccination without needles,” said Dr Greg Russell-Jones, Apollo’s Science Director. “Our initial pre-clinical studies show a high level of immune response in mice vaccinated intradermally with tetanus toxoid using our transdermal technology. This delivery method aims to stimulate the immune cells resident in the skin directly. In contrast, vaccination using traditional hypodermic syringes bypasses the very cells that can produce the best immune response.”
Apollo will continue with animal trials to optimise the formulation for tetanus vaccination and investigate the potential of other vaccines. “We look forward to developing our needle-free vaccines further and hope to begin clinical human trials late this year,” Dr Russell-Jones added.
These studies follow the success of Apollo’s earlier animal trials showing its transdermal delivery system is effective at delivering antibodies and soluble receptors through the skin to reduce inflammation.
“We are now broadening the transdermal formulation technology from anti-inflammatory molecules to the more universal market of vaccines. The tetanus vaccination results represent an extension of our transdermal delivery platform,” Mr John Priest, Apollo CEO, said. “These successful initial studies pave the way for using our transdermal
technology with many currently injected vaccines. In other words, vaccines that today have to be injected will be able to be rubbed on, in the future.”
About Apollo’s transdermal delivery technology
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. It 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. The transdermal technology opens up the possibility of treating a range of diseases with topical applications.
About Apollo’s preclinical studies
Topical Vaccination - Tetanus Vaccination02000 4000 6000 8000 10000 12000 14000 16000 18000 Control – Transdermal Formulation Topical Tetanus Toxoid Intra-muscular Tetanus Toxoid2nd vaccination3rd vaccinationAnti-tetanus toxoid titre
A series of preclinical studies compared the effectiveness of tetanus toxoid (TT) vaccinations, administered topically to pre-shaved abdominal skin using Apollo’s topical formulation or injected into the quadricep muscle (IM) of mice, in generating immunity. In these studies, three groups of ten mice were administered either tetanus toxoid in Apollo’s topical formulation, or TT via IM injection, or transdermal formulation alone. Three vaccinations were administered at 14 day intervals. Blood samples were then taken 14 days post-vaccination and the serum from each animal assayed for total TT specific IgG antibody by indirect enzyme linked immunosorbent assay (ELISA). Delayed type hypersensitivity was measured for each group by measurement of footpad swelling 48 and 72 hours following injection of TT in saline into the right footpad and saline alone into the left footpad. These models are commonly used in assessing vaccination effectiveness.
The data showed that topical vaccination with tetanus toxoid induced a higher level of antibody response than injection of tetanus alone and that topical vaccination induced an equivalent antibody response to injection of tetanus with adjuvant (heteroscedastic t-test analysis: intra-muscular TT 2nd vs. 3rd vaccination p< 0.05, topical TT 2nd vs. 3rd injection, p< 0.05).
The results indicate that topical vaccination gives a better antibody response than injection of tetanus toxoid and consistently generated high antibody levels. The resulting high level of immunity was verified by the robust delayed-type hypersensitivity responses.
About Apollo Life Sciences Limited
Apollo Life Sciences (ASX:AOP) is a biotechnology company that has made major breakthroughs in the areas of drug delivery and expression of proteins from human cells. Apollo’s combined technologies are expected to lead to more effective and lower cost therapeutics, compared to first generation protein-based drugs.
For more information: For media enquiries: John Priest, CEO Andrew Huckel Apollo Life Sciences Wilkinson Media 02 9310 1800/0419 246 356 02 8001 8888 / 0402 822 622 (www.apollolifesciences.com)