OXFORD, England, June 13 /PRNewswire/ -- Chroma Therapeutics Limited today announces that the United States Food and Drug Administration (FDA) recently approved its Investigational New Drug (IND) application for the clinical development of its oral, once-daily experimental cancer therapy CHR-2797. Following this approval, Chroma will shortly initiate its second Phase II trial, in non-small cell lung cancer (NSCLC). This follows the recent initiation of a Phase II trial for this drug in acute myeloid leukaemia.
The entry of CHR-2797 into this first Phase II solid tumour clinical study follows the successful completion of a Phase I study with CHR-2797 in patients with advanced metastatic solid tumours. The final data from this study was presented as a poster at the recent American Society of Clinical Oncology (ASCO) meeting in Chicago, and was selected by ASCO for poster discussion at the meeting.
Headline data from the study, which was presented by a key study investigator, Dr. Andrew Protheroe of the Churchill Hospital, Oxford UK, showed one partial responder (PR) and six patients with confirmed stable disease of at least three months duration, as assessed using RECIST criteria, out of a total of 41 patients treated with a variety of doses of the drug. The drug was well-tolerated during the study and drug exposure was consistent with the proposaed once-daily oral dosing. The full ASCO poster is available at the company's website, www.chromatherapeutics.com.
Ian Nicholson, Chief Executive Officer of Chroma, commented: "We are pleased to have met this major milestone with the approval of Chroma's first IND application and to be entering our second Phase II clinical trial. We believe the Phase I data demonstrates this new agent could be used for the treatment of a number of solid tumours, including NSCLC, a patient group which has substantial unmet medical need."
Enquiries Chroma Therapeutics Limited Ian Nicholson Chief Executive Officer +44 (0)1235 829120 Richard Bungay Chief Financial Officer Brunswick Jon Coles +44 (0)20 7404 5959 Justine McIlroy
About aminopeptidases and CHR-2797
Aminopeptidases are a family of intracellular enzymes involved in the supply of amino acids that are essential for cell growth. Inhibition of aminopeptidases has been shown to halt cell growth or cause apoptosis (cell death) in a large number of cancer cell lines. Conversely, normal (non-tumour) cell lines have been shown to be insensitive to aminopeptidase inhibition. CHR-2797 is a potent inhibitor of aminopeptidases that has demonstrated strong preclinical efficacy as monotherapy and has also been shown to strongly synergise with a number of leading cancer therapies in a range of cancer cells.
About Chroma Therapeutics
Chroma Therapeutics, based in Oxford (UK), is a drug discovery and development company focused in the fields of oncology and inflammatory disorders. Chroma is building a broad pipeline of first -- or best-in-class treatments utilising its expertise in chromatin biology and its novel intracellular accumulation technologies, which include the ability to selectively target drugs to macrophages. Chroma is backed by a number of leading specialist investors, including Abingworth, Essex Woodlands, Gilde, Nomura Phase4 and The Wellcome Trust.
More information about Chroma can be found at www.chromatherapeutics.com.
Chroma Therapeutics LimitedCONTACT: Ian Nicholson, Chief Executive Officer, or Richard Bungay, ChiefFinancial Officer, both of Chroma Therapeutics Limited, +44 (0)1235 829120;Jon Coles or Justine McIlroy, both of Brunswick, +44 (0)20 7404 5959, forChroma Therapeutics Limited
Web site: http://www.chromatherapeutics.com/
