SOURCE: Antisoma plc

October 13, 2010 02:08 ET

Antisoma Interim Management Statement

LONDON and CAMBRIDGE, MA--(Marketwire - October 13, 2010) - Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) today publishes its Interim Management Statement for the period from 1 July to 12 October 2010.

Antisoma's CEO, Glyn Edwards, said: "We are on track to report pivotal trial results for AS1413 in the first half of next year. If these are positive, we will file marketing applications. Our latest market research suggests that AS1413 could generate very substantial sales revenues."


  * New market research indicates potential sales of up to $670 million per
    annum in acute myeloid leukaemia (AML)
  * Phase III trial in secondary AML fully enrolled
  * Phase III trial results expected H1 2011

  * Phase IIb trial in AML ongoing, extended to India
  * Phase IIb data expected H1 2011

Joint Chairman and CEO's statement

We will soon report data from two important clinical trials: a phase III study of AS1413 and a phase IIb study of AS1411. The AS1413 trial is most critical because positive data would lead to submissions for marketing authorisations.

AS1413 in the spotlight

In September we announced that we had completed the enrolment of over 420 patients into 'ACCEDE', a pivotal phase III trial evaluating AS1413 as a treatment for secondary AML. This put us on track to report the trial's outcome in H1 2011. Collection and collation of data remains on course for that timing. ACCEDE is the biggest randomised trial conducted to date in secondary AML.

We have recently completed a large market research and forecasting exercise to evaluate the revenues that could be achieved following launches of AS1413. This focused mainly on the opportunity in the U.S., but has also served to refine our view of potential sales in other markets. The exercise included an analysis of all claims made under the U.S. Medicare system for the treatment of AML during 2008 and a survey of 150 U.S. oncologists and haematologists who treat AML patients.

Our forecasts based on this research indicate that peak global sales of AS1413 could reach $670 million per annum if we gain initial approvals for treatment of patients with secondary AML and subsequent approvals for use in older 'de novo' AML patients. With approvals in secondary AML alone, we could expect global peak sales in the range of $440 to $580 million.

We continue to talk to potential licensing partners for AS1413. There is interest in global and regional partnerships. However, we will only conclude a deal or deals before phase III data if compelling terms are available.

AS1411 also approaching key results

We are enrolling patients into a phase IIb trial of AS1411 in AML, which builds on positive findings from an earlier phase II trial in the same setting. We recently expanded the geographical reach of the study to include India in addition to sites already active in the U.S., South Korea, Taiwan, Australia and New Zealand.

We expect to report headline findings from the phase IIb trial in the first half of 2011. If these are positive, the next step will be a pivotal phase III trial in AML, as well as consideration of opportunities for the drug in other cancer settings. Clinical and non-clinical data suggest that AS1411 could have application across a number of blood cancers and solid tumours.

DCAM programme progressing towards partnering

Our DCAMs (dendritic cell auto-immune modulators) are highly specific, small- molecule inhibitors of wild-type Flt3 designed for oral treatment of auto- immune conditions. Following positive results in animal models of inflammatory bowel disease and rheumatoid arthritis, we are working towards establishing a licensing partnership for further development of the programme.

Cash resources meet business needs

Our existing cash resources are anticipated to cover the needs of the business until well after we report our critical trial data in the first half of calendar 2011.


Our current focus is delivery of the clinical data for AS1413 and AS1411 and preparation to ensure we can move rapidly to exploit positive outcomes from the trials of either or both of these drugs.

Barry Price

Glyn Edwards
Chief Executive Officer

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 July 2010 to 12 October 2010.

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.


This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:

(i) the releases contained herein are protected by copyright and other applicable laws; and

(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Antisoma plc via Thomson Reuters ONE

Contact Information

  • Enquiries:

    Antisoma plc

    Glyn Edwards,
    Chief Executive Officer
    Daniel Elger,
    VP, Marketing & Communications
    +44 (0)7909 915 068

    Buchanan Communications
    Mark Court,
    Lisa Baderoon,
    Jessica Fontaine
    +44 (0)20 7466 5000