drugset / Press release

PAT-SM6 Phase I/IIa Multiple Myeloma Trial Results Published

2015-02-03 · Patrys Ltd. · original patrys.com ↗

ASX & Media Release PAT-SM6 Phase I/IIa Multiple Myeloma Trial Results Published  Publication in peer reviewed journal provides further validation of PAT -SM6 as a treatment for multiple myeloma Melbourne, Australia; 4 February, 2015 : Patrys Limited ( ASX: PAB ), a clinical stage biopharmaceutical company, today announced that results from the PAT-SM6 Phase I/IIa, open-label study in patients with refractory or relapsed multiple myeloma(MM), have been published in a peer- reviewed journal Haematologica. The article is currently available on line and will be included in an upcoming print edition of the journal. The article provides a summary of the results of the clinical study conducted in twelve heavily pre - treated MM patients that received four escalating doses of PAT-SM6, over a period of two weeks, via intravenous infusions at 0.3, 1, 3, and 6 mg/kg doses. Safety and tolerability, the primary objectives of this study, have been successfully supported with all doses administered found to be safe, well tolerated and the maximum tolerated dose (MTD) not reached. Four out of twelve patients (33.3 %) had stable disease after PAT -SM6 treatment across the dose cohorts 1, 3 and 6 mg/kg according to the International Myeloma Working Group (IMWG) criteria. The data is comparable to other antibodies under clinical development for the treatment of MM. Treatment of rel apsed-refractory MM continues to present a therapeutic challenge, prompting a continued search for additional therapeutic options. The trial results are also important because they reflect in vivo activity in a difficult -to-treat patient population. Targeting GRP78, which is responsible for resistance in many cancers, highlights the prospective role of PAT -SM6 in combination with the existing therapies to overcome tumour resistance. Furthermore, the favorable safety profiles of PAT -SM6 make it a likely ca ndidate for possible synergistic results in combination with other therapies while maintaining low toxicity. The publication also includes supplementary data on an interesting observation made during the course of the trial regarding immune mechanisms of PAT-SM6 and its possible role in overcoming tumour resistance. Publication of this data in peer reviewed journal Haematologica further validates PAT -SM6 as a clinical candidate. The article is available at: http://www.haematologica.org/content/early/2015/01/26/haematol.2014.117945. -Ends- For further information, please contact: Roger McPherson Kyahn Williamson Kellie Hanrick Chief Executive Officer Buchan Consulting Buchan Consulting P: +61 3 9670 3273 P: +61 3 9866 4722 P: +61 3 9866 4722 [email protected] [email protected] [email protected] About Patrys Limited: Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibodies as therapies for cancer and other major diseases. Patrys has a deep pipeline of anti -cancer natural human antibodies that enable both internal devel opment and partnering opportunities. More information can be found at www.patrys.com About PAT-SM6: PAT-SM6 is a natural human IgM antibody which has been shown to have potent anti -cancer properties in a large number of laboratory and animal studies. More specifically, Patrys has screened PAT -SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to o ver 90% of the tumours screened regardless of cancer type , patient age, gender or disease stage. Patrys has filed patent applications to cover the PAT -SM6 antibody molecule, disease target and the mechanism of action. Patrys’ PAT - SM6 has shown convincing evidence of potential therapeutic benefit in the recently completed Phase I/IIa clinical trial in patients with relapsed and refractory multiple myeloma. PAT -SM6 has been granted orphan drug status in Europe and the USA for multiple myeloma. Patrys has al so successfully completed a Phase I clinical trial to evaluate PAT -SM6 as a therapy for melanoma. Patrys is now prepari ng for the next clinical trial, a combination study of PAT-SM6 and a proteasome inhibitor. About Multiple Myeloma: Multiple myeloma is a type of bone marrow cancer arising from plasma cells, and new therapies are desperately needed to treat patients who become resistant to established chemotherapeutics. There is an estimated 220,000 cases worldwide and the incidence is increasing. The five -year survival of patients is approximately 30% (at 10 years ~20%). Despite new marketed therapies, multiple myeloma remains largely incurable and fatal. The multiple myeloma market is domina ted by three major products: Revlimid, Velcade and Kyprolis (Carfilzomib) with combined net sales greater than US$ 8 Billion in 2013.

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