Clavis Pharma ASA (OSE: CLAVIS), the Norwegian cancer drug development company, announces that its clinical development programme with elacytarabine for the treatment of patients with acute myeloid leukaemia (AML) has been granted Fast Track designation by the US Food & Drug Administration (FDA).
Elacytarabine is currently being evaluated in a randomised Phase III trial (known as the CLAVELA study) comparing it with the investigator’s choice of treatment in patients with late-stage AML (i.e. those who have failed two or three previous treatment regimes). The primary objective of the study is to compare overall survival between patients treated with elacytarabine and those treated with investigator’s choice. In a Phase II study, treatment with elacytarabine showed a statistically significant median survival benefit of 5.3 months compared to 1.5 months in published clinical data for late-stage AML.
The CLAVELA trial enrolled its first patient in August 2010 and aims to recruit 350 patients at 65 sites in the USA, Canada, Australia and Europe. The company expects to complete patient recruitment by the end of 2011 and to report top-line results in the second half of 2012. The results from this study, if positive, will be used by Clavis Pharma to support regulatory filings in the USA and Europe.
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A priority review is expected to take six months from NDA submission, rather than ten months for a standard review. The Company may also decide to submit certain sections of the NDA (preclinical, CMC and clinical) as they become available, under a Rolling NDA.
Olav Hellebø, CEO of Clavis Pharma, said: “We are pleased to have been granted Fast Track designation from FDA for our elacytarabine programme, alongside the Orphan Drug designation granted previously. It confirms that there is a significant need for a new treatment for AML given the proportion of patients who do not respond to standard cytarabine treatment or who become less responsive over the course of such treatment. Elacytarabine has the potential to offer a new therapeutic option to these patients and we are focused on enrolling patients into the Phase III CLAVELA study as quickly and efficiently as possible with the aim to confirm the positive results we saw in Phase II.”
About Elacytarabine
Elacytarabine is a novel, patented lipid-conjugated (LVT) form of the anti-cancer drug cytarabine (Ara-C) that has the potential to improve treatment outcomes in patients with AML and other haematological malignancies (leukaemias). One important advantageous characteristic of elacytarabine is its ability to enter cancer cells independently of a specific cellular uptake mechanism (human Equilibrative Nucleoside Transporter or hENT1), compared to cytarabine, which is dependent on this transporter for entry into cells. Many AML patients have low expression levels of hENT1 and a low level is known to be associated with a poor outcome to treatment of AML with cytarabine.
Currently, cytarabine is the backbone of treatment for patients suffering from AML and other haematological cancers such as acute lymphocytic leukaemia (ALL) and in lymphomas. While cytarabine can induce remission in many AML patients, a significant number proportion of patients do not respond to treatment. Furthermore, both the duration of remissions and the ability to maintain long-term control of AML remain as the most significant unmet medical needs.
Elacytarabine has been granted Orphan Drug designation to elacytarabine for the treatment of AML by the US FDA and the European Medicines Agency (EMA). These designations entitle Clavis Pharma to exclusive marketing rights for seven and ten years in the USA and the EU, respectively, from the date of the marketing approval.
Source:
Clavis Pharma