Data on ATL1101 Prostate Tumour Suppression Published in Scientific Journal & Australian Patent Granted

* ATL1101 Prostate Cancer Research Results Published in International Scientific Journal “The Prostate”
* Australian Patent Granted Covering use of ATL1101 in Prostate and other Cancers

Victoria, Australia | February 3, 2010 | Antisense Therapeutics (ANP) is pleased to report two recent value-adding outcomes relevant to the company’s anticancer drug ATL1101. Firstly, a publication describing ATL1101 pharmacology in prostate cancer cells and tumours will be published in this month’s edition of the highly regarded international scientific journal ‘The Prostate’. Secondly, an Australian Patent has been granted on the use of ATL1101 as a therapeutic agent to treat prostate cancer.

The research paper entitled ‘Antisense Oligonucleotide Targeting of Insulin-Like Growth Factor-1 Receptor (IGF-1R) in Prostate Cancer’, appears in the February 2010 issue of The Prostate (The Prostate, 1 February 2010, Volume 70, Issue 2, Pages 206-18). The key findings as previously reported by ANP and now reported in this paper are that ATL1101 suppressed the growth of human prostate tumours in key mouse models of prostate cancer and delayed their transition to the most dangerous form of the disease, castration-resistant prostate cancer (CRPC), The publication of this data in a high quality, peer-reviewed scientific journal strengthens the body of pharmacological data that ANP has now developed in collaboration with Prof Martin Gleave’s Vancouver Prostate Centre.

Further value has been created for ATL1101 with the granting last month of Australian Patent No. 2004210882, entitled “Modulation of insulin like growth factor I receptor expression”, covering the use of ATL1101 for any disease. This granted patent adds to a patent portfolio covering the commercial clinical use of ATL1101 that includes broad antisense patents accessed via our partnership with Isis Pharmaceuticals, as well as US patent application US12/578,471 pending, covering the use of ATL1101/IGFIR targeting drugs in prostate and other cancers. This expanded patent portfolio provides protection for ATL1101 to 2024, extendible up to 2029 in US, Australia, Europe and Japan.

“Publication in a high quality scientific journal and the granting of an Australian patent are both illustrative of our strategy to prudently and progressively add value to the ATL1101 asset,” commented Antisense Therapeutics’ Managing Director Mark Diamond.

Prostate cancer is the second most frequently diagnosed cancer in men after skin cancer. It is estimated there will be 218,890 new cases diagnosed in the U.S. this year. Around 1 in 6 men will develop prostate cancer, a third to a half of whom will recur after local treatment and risk progression to metastatic prostate cancer. Metastatic disease invariably progresses to hormone refractory or castrate resistant prostate cancer (CRPC) if given enough time. Prostate tumours are initially androgen (male sex hormone) dependent, and can be treated with androgen ablation therapy (the term “castration” can be used to describe removal of the source of androgen), however once the disease progresses to its most dangerous and aggressive form, CRPC, treatment options are limited and prognosis is poor. Treatment options depend on disease severity and include radiation and chemotherapy, which are designed to induce programmed cell death (apoptosis) of tumour cells. There is a pressing need for the development of new treatment options.

ATL1101 is an antisense inhibitor of IGF-IR, which has shown potent activity in laboratory studies, including in human cancer cells. IGFIR is one of the best known of a family of cell signalling molecules that are referred to as “anti-apoptotic”. These molecules prolong cell survival by inhibiting programmed cell death (apoptosis). The connection between IGF-IR activity and prostate cell tumorigenicity has been studied for many years. Drugs targeting IGF-IR are designed to slow down tumour growth and make tumour cells more susceptible to cell death. Inhibition of IGF-IR is also designed to make tumour cells more susceptible to killing by cytotoxic treatments like radiation therapy and chemotherapy. Such therapeutic approaches are under investigation in several large pharmaceutical companies, lending support to our own antisense-based strategy against the same target. Designed to block IGF-IR synthesis, ATL1101 offers potential advantages over other therapies targeting IGF-IR due to its highly differentiated pharmacokinetics and unique antisense mode of action. ATL1101 was a product of a discovery collaboration between ANP and Isis Pharmaceuticals (Nasdaq: ISIS) and utilizes second-generation antisense technology, licensed from Isis. Several antisense drugs with the same chemical modifications and design as ATL1101 are advancing in cancer clinical trials, strengthening support for second-generation drugs as targeted cancer therapeutics. For example OGX- 011, developed by OncoGenex and Isis, and recently licensed to Teva Pharmaceutical Industries, has demonstrated significant clinical benefit when combined with chemotherapy (increased survival time compared to patients receiving chemotherapy alone) in Phase II clinical studies in CRPC and non-small cell lung cancer (NSCLC).

Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialise antisense pharmaceuticals for large unmet markets. ANP has two drugs in development and two drugs in pre-clinical research. ATL1102 (injection) is in the advanced stages of a Phase IIa trial as a potential treatment of multiple sclerosis. ATL1103 is a second-generation antisense drug designed to lower blood IGF-I levels and is entering preclinical development as a potential treatment for acromegaly and vision disorders. ATL1102 (inhaled) is at the pre-clinical research stage as a potential treatment for asthma. ATL1101 is a second-generation antisense drug at the pre-clinical research stage being investigated as a potential treatment for prostate cancer. ATL1102 has been licensed to Teva Pharmaceutical Industries Ltd.

SOURCE: Antisense Therapeutics

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