announcement out Is aop in pre-open?ASX/Media Announcement 17...

announcement out Is aop in pre-open?

ASX/Media Announcement 17 October, 2006
Apollo: needle-free psoriasis treatment outperforms competitors
Apollo Life Sciences (ASX: AOP) today announced that its TNF blocker, ALS-00T2, has outperformed current market
leaders in comparative preclinical studies with etanercept, infliximab and adalimumab.
The studies indicate that Apollo’s proprietary TNF (Tumour Necrosis Factor) blocker generates fewer antibodies, and
reduces inflammation at least as effectively as the other anti-TNF molecules when injected subcutaneously or delivered
transdermally through the skin using Apollo’s TransDTM technology.
The TNF blocker market is estimated to be worth over US$8.5 billion annually, with a growth rate of 30%. TNF blockers are
used to treat inflammatory diseases such as psoriasis and rheumatoid arthritis. Apollo is preparing to enter Phase 2 clinical
trials for its ALS-00T2 topical psoriasis treatment, having successfully completed Phase 1b trials earlier this year. A topical
rheumatoid arthritis treatment that uses the same technology is also being prepared for clinical trials.
A series of animal studies was conducted to compare Apollo's human cell expressed (hcxTM) TNF blocker with three major
products currently available for its ability to reduce inflammation. Inflammation was induced using Carrageenan, and
solutions were applied then and daily, either by subcutaneous injection or topically using TransDTM. Swelling was measured
twice daily over a period of up to 14 days. This animal model is commonly used to study cellular accumulation during the
induction of the inflammatory process.
The results indicated that ALS-00T2 is at least as effective as the existing products at reducing swelling in this model when
administered by injection or topically. The studies confirmed earlier findings that ALS-00T2 is effective at reducing
inflammation, and that Apollo’s transdermal delivery technology, TransDTM, delivers biologically active large proteins and
antibodies across the skin.
Separate animal studies indicated that ALS-00T2 has the additional advantage of causing a significantly lower immune
response than a comparable TNF blocker produced in CHO cells when injected subcutaneously (p-values < 0.0024).
Apollo's Science Director, Dr Greg Russell-Jones, said: “The studies show great promise for our upcoming Phase 2 topical
psoriasis trial. They indicate that Apollo’s molecule is at least as effective as the best in the market at reducing TNF activity,
which is one of the key elements of the inflammatory process. This dramatically increases the probability of success in our
upcoming clinical trials.”
The other major advancement is Apollo’s ability to transfer TNF blocker molecules through the skin. “There is a strong
demand for treatments that can be delivered more conveniently and painlessly, and with fewer side effects, than those
currently available,” Dr Russell-Jones said. “Currently, TNF blockers can only be taken by injection, either subcutaneously
or intravenously.”
“Apollo’s topical ALS-00T2 will be easier and less painful to administer. It will also potentially create fewer side effects. The
active ingredient is applied directly to the site where it is needed, rather than affecting the body’s entire immune system.
Further, as the protein itself is expressed from human cells, it can be expected to cause a much lower immune response in
humans than the competitor products do.”
“We are very pleased with these results as we continue to push forward with preclinical studies and scale up in preparation
for the Phase 2 trial. We are also considering approaches from overseas companies about developing our TNF blocker for
subcutaneous delivery,” said Dr Russell-Jones.
For more information: For media enquiries:
Dr Greg Russell-Jones, Science Director Julian Elliott
Apollo Life Sciences Wilkinson Media
02 9310 1800 02 8001 8888 / 0425 840 071
(www.apollolifesciences.com)
About Apollo’s TransDTM transdermal delivery technology
Apollo's non-invasive transdermal carrier, TransD™, is based on a proprietary formulation that is able to deliver large watersoluble
proteins across the skin and into the surrounding dermal and hypo-dermal layers. It can deliver a wider range of
molecules than existing transdermal technologies in terms of size and water or oil solubility. Drugs up to antibody size,
including leading biopharmaceuticals that have previously been considered unsuitable for transdermal delivery, have been
identified as potential candidates for TransD™. “Proof of concept” has been demonstrated with water-soluble molecules
ranging from 5,000 to 150,000 daltons+ (the size of an antibody molecule)..
The transdermal technology opens up the possibility of treating a range of diseases with topical applications.
About Apollo’s human cell expressed (hcxTM) proteins
Apollo has created a library of recombinant human proteins that closely mimic proteins in the human body because they are
expressed from human cells (hcx™). Both their amino acid sequence (composition) and post-translational modifications
(PTMs or attachments) are human. By contrast, recombinant human proteins produced from bacteria, yeast or murine cells
lack human attachments. Research and clinical experience with first-generation biopharmaceuticals are now showing that
the human-ness of the attachments in particular is central to how a protein performs its role in the body.
Apollo focuses on ensuring its hcx™ proteins are as close to the natural form as possible, to optimise their usefulness as
potential therapeutics, diagnostics and research tools. The company's extensive range of hcx™ proteins forms a target-rich
bank of candidates that can be selected, refined and developed into biopharmaceuticals to treat a wide range of diseases.
About Apollo’s pre-clinical comparative studies
A series of preclinical studies compared the effects of Apollo’s ALS-00T2 with etanercept, which is marketed under the
brand name Enbrel®, infliximab, marketed as Humira® and/or adalimumab, marketed as Remicade®, on reducing
inflammation when delivered by subcutaneous injection or topically using TransD™. Apollo’s TNF blocker is a protein,
which binds to TNF in a similar fashion to one of the three market leading TNF blockers, etanercept, which is also based on
a protein, while two others, adalimumab and infliximab, are based on antibodies developed against TNF.
The studies, which involved more than thirty groups with ten animals per group and six control groups, utilised an extended
Carageenen model of inflammation. Carrageenan has been shown to initiate cellular accumulation of macrophages then
polymorphonuclear cells in a mouse footpad. The model provides a test for the ability of treatments to block cellular
accumulation. In all studies, mice were administered a control solution or one of four treatments either by subcutaneous
injection or topically using TransDTM. Treatment was continued for up to two weeks and foot size was measured at regular
intervals – typically at the six hour and 24 hour time point daily.
Comparison of subcutaneously injected treatments showed that Apollo’s ALS-00T2 consistently performed at least as well
as etanercept, adalimumab and infliximab, and outperformed two at reducing footpad swelling (p-value = 0.05). Results
also showed that topically administered ALS-00T2 reduced swelling in comparison with the control, TransDTM alone
(p-value = 0.05), and that it was at least as effective in reducing swelling as two of the comparison treatments.
A separate study compared the immune response to subcutaneous injection between ALS-00T2 and the protein-based
TNF blocker, which is produced in CHO (Chinese Hamster Ovary) cells. Antibody levels in serum were used to measure
immune response. Ten mice were vaccinated with ALS-00T2 and ten with the CHO-derived treatment. The serum from
each group of vaccinated mice was tested against both treatments. Results showed that there was a significantly lower
antibody response in mice injected subcutaneously with ALS-00T2 than in mice injected subcutaneously with the
commercially available TNF blocker (p-values < 0.0024).
Further pre-clinical studies are being conducted in preparation for clinical trials.
About psoriasis
Psoriasis is a severe skin rash that can seriously affect health and quality of life, and is rarely completely cured. It affects
3% of the western population and tens of millions of people in Asia. The condition is caused by an immune overreaction
which leads white blood cells to enter the upper layers of the skin, causing skin cell over-growth and raised lesions.
Treatments can typically only reduce discomfort, rather than eliminate the condition. They are usually required for a period
of years and often entail unwanted side effects. The market for psoriasis treatments was estimated at US$5.1 billion in
2003.
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.