13 October 2005
Clavis Pharma, a biopharmaceutical company focusing on the development of improved cancer therapeutics, today announced that the first patient has been included in the first Phase II study with its lead drug candidate, ELACYTTM.
The phase II study is a multi-centre study in patients with malignant melanoma where ELACYT will be given as monotherapy to chemo-and immunotherapy naive patients. Approval for this phase II has been granted both in Europe and in the US. The two European sites are The Norwegian Radium Hospital, Norway, and Lund University Hospital, Sweden, under the direction of Dr. Svein Dueland and Dr. Lotta Lundgren, respectively. The US part of the Phase II study will be conducted at the University of Pittsburgh, under the direction of Dr. John Kirkwood and Dr. Sanjiv Agarwala.
"The approvals and initiation of this phase II study represents a major milestone for Clavis Pharma." says Tom Pike, Chairman and CEO of Clavis Pharma. "The go ahead to study ELACYT as monotherapy in previously untreated patients this early in the drug development is a great achievement for a new cancer drug. We are also pleased to be working with some of the world's leading experts within the field and especially that our clinical programme now is extended to include the USA."
"We have seen cessation of tumour growth with ELACYT in a number of melanoma patients in phase I and are pleased to make this drug available to future patients as well" says Dr. Svein Dueland, from The Norwegian Radium Hospital, where the first patient in phase II was recently treated. "We are encouraged to continue into phase II with ELACYTTM based on the promising results in phase I in our hospital"
For more information, contact Clavis Pharma:
Tom Pike - Chairman & CEO (+ 47) 24 11 09 50
tom.pike@clavispharma.com
Ole Henrik Eriksen - President and COO (+47) 24 11 09 50 ole.henrik.eriksen@clavispharma.com