LONDON--(Marketwire - May 07, 2009) -
London, UK, and Cambridge, MA: 7 May 2009 - Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today publishes its Interim Management Statement for the period from 1 January to 6 May 2009.
Antisoma’s CEO, Glyn Edwards, said: “Our goal is to become a company that not only develops but also commercialises novel cancer treatments. We have two drugs, ASA404 and AS1413, that are now well into pivotal phase III trials designed to support marketing applications. We will also be presenting phase II results for a third drug, AS1411, at the ASCO meeting later this month.”
Eric Dodd, Antisoma’s CFO, added: “We already have funds to support product development through mid-2010, but in the next two months we expect to extend this significantly through a deal to divest our FDA-approved drug, oral fludarabine. Following the deal, we expect to have funds to support all our priority programmes through mid-2011, well past the time when we expect key phase III results for ASA404 and AS1413.”
Joint Chairman and CEO’s statement
ASA404 - potential blockbuster being developed by Novartis
Our Tumour-Vascular Disrupting Agent, ASA404, is being developed by Novartis following our worldwide licensing deal in 2007. The drug is in two pivotal phase III studies in non-small cell lung cancer: ‘ATTRACT-1' is evaluating ASA404 in previously untreated patients, while ‘ATTRACT-2' is testing ASA404 in patients who have received a previous round of treatment with other drugs. These large studies are recruiting around 2,000 patients across the world. It is anticipated that data from ATTRACT-1 will be available to support regulatory filings in 2011 and that the ATTRACT-2 study will be completed during 2011.
Novartis recently decided to extend investigation of ASA404 to patients with metastatic breast cancer, another major cancer indication. More details of the clinical trials programme in breast cancer will be announced when available.
Since ASA404 is being developed as a treatment for some of the most common cancers, it has the potential to achieve blockbuster levels of sales. This would generate substantial royalty payments to Antisoma. We have an option to co-commercialise ASA404 in the United States.
AS1413 - building towards US commercialization
AS1413 is a novel chemotherapy drug that evades multi-drug-resistance mechanisms which contribute to the failure of chemotherapy treatments in some cancer settings. We are developing this drug independently with the intention of selling the drug ourselves in the US while seeking partnerships for commercialisation in other territories.
AS1413 is in a phase III trial (“ACCEDE”) for secondary acute myeloid leukaemia (secondary AML), where multi-drug resistance is common and outcomes with existing treatments are poor. This trial is being conducted under a Special Protocol Assessment from the US Food and Drug Administration. It is expected to report data in late 2010 or early 2011.
There are currently no drugs licensed specifically for the treatment of secondary AML, and we estimate that AS1413 could achieve sales running into hundreds of millions of dollars worldwide.
AS1411 - AML phase II data to be presented at ASCO
Our aptamer drug, AS1411, is in two phase II studies - one in AML and one in renal cancer. In December we reported promising interim findings from the AML trial. Final data from this trial will be presented at the ASCO (American Society of Clinical Oncology) Annual Meeting later this month. An abstract including interim data will be available on the ASCO website (www.asco.org) from 14 May, while the full data will be made available at the time of the meeting presentation on 29 May. We have now completed recruitment of patients into the phase II trial of AS1411 in renal cancer. Initial data from this trial will be available later this year, with final data in 2010.
AS1402 - recruitment completed in phase II breast cancer study
We have now completed recruitment into a 110-patient randomised phase II trial of our antibody drug AS1402. Treatment and follow-up of patients are ongoing, and results of the trial will be available next year.
AS1409 - phase I data to be presented at ASCO
Our antibody-cytokine fusion protein, AS1409, is being evaluated in a phase I trial in patients with malignant melanoma or renal cancer. Data from this trial will also be presented at the ASCO meeting; an abstract will be available on the ASCO website from 14 May and full data will be presented at the meeting.
Maintaining a strong cash position
We reported in our interim financial results that we had GBP 52.7 million at the end of December 2008, which is sufficient to support all our priority programmes until mid-2010. We expect that the deal to divest oral fludarabine will enable the Company to be funded through mid-2011, comfortably beyond the expected timing of key phase III data on ASA404 and AS1413.
Outlook
We expect to divest oral fludarabine before the end of June. We also anticipate a cascade of clinical data, starting with the AS1411 AML and AS1409 data being presented at ASCO. This will continue later in 2009 with the first data from our phase II trial of AS1411 in renal cancer, followed during 2010 by final data from this trial and phase II data on AS1402 in breast cancer. Looking a little further ahead, we look forward to the conclusion of three phase III trials, on ASA404 and AS1413, during the period from late 2010 through 2011.
Enquiries: Glyn Edwards, CEO Daniel Elger, Director of Communications +44 (0) 7909 915068 Antisoma plc Mark Court/Lisa Baderoon/Rebecca Skye +44 (0)20 7466 5000 Dietrich Buchanan Communications Brian Korb +1 646 378 2923 The Trout Group
This Interim Management Statement is published in accordance with the UK Listing Authority’s Disclosure Rules and Transparency Rules, in respect of the period from 1 January 2009 to 6 May 2009.
Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company’s clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management’s current expectations, but actual results may differ materially.
Background on Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical company that develops novel products for the treatment of cancer. The Company has operations in the UK and the US. Please visit www.antisoma.com for further information about Antisoma.
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