Sydney, Nov 1, 2006 AEST (ABN Newswire) - Apollo Life Sciences (ASX: AOP) today announced that it is beginning preclinical tests for a tableted TNF blocker for arthritis using its breakthrough technique for oral delivery of large water soluble proteins and antibodies.
Drugs for rheumatoid arthritis, known as TNF blockers, are usually injected or given via intravenous drip - which is very inconvenient for patients and can take up to two hours. TNF blockers are regarded as among the best treatments for arthritis, relieving its symptoms and slowing the speed of joint damage.
The market for TNF blockers is worth approximately $8.5 billion globally (see below). TNF blockers were the top selling biotech drugs in 2005, and are growing in popularity in the treatment of inflammatory conditions such as arthritis, psoriasis and Crohn's disease.
Apollo has developed its own TNF blocker - ALS-00T2 - for delivery in tablet form. It has already proven effective at reducing inflammation in animal trials when injected or applied to the skin, and has completed Phase 1b clinical human trials for psoriasis.
Apollo's oral delivery system, known as Oradel TM , will potentially transform the experience for patients. A special tablet coating stops the drug being degraded in the stomach and delivers it into the circulatory system where it can do its work. This could also save the health system substantial amounts of money by reducing the number of patients visiting doctors' offices to have drips administered.
"The early indications show great promise of real benefits for arthritis sufferers," said Dr Greg Russell-Jones, Apollo's Science Director. "Our earlier pre-clinical results suggest that our TNF blocker has advantages over existing multi-billion dollar products. The studies also showed it is less likely to cause adverse immune reactions."
Apollo will begin animal trials of ALS-00T2 using Oradel TM as the basis for needle-free delivery. The trials will assess whether the TNF blocker delivered orally is effective at reducing inflammation in mice. "We look forward to developing our tablet TNF blocker further and hope to begin clinical human trials in 2007," Dr Russell-Jones added.
The studies follow the success of Apollo's earlier animal trial with oral insulin using Oradel TM to provide needle-free delivery, which reduced blood glucose levels in diabetic rats.
"We are now broadening the Oradel TM technology from insulin to the larger market of anti-inflammatories. The TNF blocker development represents an extension of our oral delivery platform," Dr Russell-Jones said.
"Successful studies with the TNF blocker will pave the way for using Oradel TM technology with any of the current antibody therapy technologies on the market. In other words, antibodies used in medicine that today have to be injected will be able to be delivered in tablet form."
Estimates put revenues for the three leading TNF blocker products at over US$8.5 billion in 2005. Sales for 2006 are based on estimated first half sales. Source: Signals Magazine.
Product name Est. 2005 sales (US$) Est. 2006 sales (US$)Enbrel $ 3.7 billion $ 4.2 billionRemicade $ 3.5 billion $ 4.0 billionHumira $ 1.4 billion $ 1.6 billion
About Apollo's Oradel TM oral delivery technology
Apollo's oral delivery technology, Oradel TM , is able to entrap large, water soluble proteins up to antibody size within a protective coating, providing protection from degradation in the stomach. The technology also uses targeting agents to promote absorption of the molecule from the intestine.
Oral delivery of proteins is a breakthrough because the stomach's digestive acids usually destroy proteins before they can be taken up by the body, and the stomach lining typically prevents material from passing into the bloodstream.
Apollo's Oradel TM technology enables controlled release of the active molecule and, thus, a large pharmaceutical window. Pre-clinical studies indicate it transports large protein molecules, up to 150kDa in weight, within protective structures of around 200nm in size. Each cell in the stomach wall transports the coated material at a different rate, allowing for a controlled release of the drug into the circulation. Once the protective structure is released into circulation, it collapses and the drug is released.
Preclinical studies on the oral delivery technology using large proteins have demonstrated effective delivery of bioactive molecules.
About Apollo's human cell expressed (hcx TM ) 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(TM)). 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(TM) 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(TM) proteins forms a target-rich bank of candidates that can be selected, refined and developed into biopharmaceuticals to treat a wide range of diseases.
Contact
Dr Greg Russell-Jones
Science Director
+61 2 9310 1800
www.apollolifesciences.com
Julian Elliott
Wilkinson Media
+61 2 8001 8888 / +61 425 840 071
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