Oslo, Norway, 21 February 2008 – Algeta ASA (OSE: ALGETA), the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin(TM) in HRPC patients in the USA. Algeta filed its Investigational New Drug (IND) application for its lead product Alpharadin(TM) with the United States Food and Drug Administration (FDA) in December 2007. The statutory 30 day consultation period was extended by the FDA for a further 30 days by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application. Alpharadin(TM) has already been studied in phase II clinical trials in Europe and has demonstrated a potential for a significant survival benefit in hormone-refractory prostate cancer (HRPC) patients with skeletal metastases.
An initial Phase I pharmacokinetics, biodistribution and dosimetry study (BC1-08) with Alpharadin in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York, one of the world’s leading oncology centers. This US trial will further expand the information obtained in a similar phase I study (BC1-05) conducted at the Royal Marsden Hospital in London, for which patient enrolment has recently been completed.
Following the start up of the BC1-08 trial, Algeta will continue discussions with the FDA to agree on the design of the further clinical development program for Alpharadin(TM)
“We are delighted to have been given the clearance by FDA to advance Alpharadin into clinical development in the United States, and to be working with one of the world’s leading cancer centers on our clinical program,”
said Dr. Thomas Ramdahl, President and CEO of Algeta.
“There is a great unmet medical need among men suffering from HRPC with skeletal metastases and the opening of this US clinical trial will be an important step in our overall clinical development of Alpharadin. As earlier announced, we plan to initiate an international pivotal phase III clinical trial with Alpharadin in HRPC patients during the first half of 2008.”
For further information, please contact
Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)
Geir Christian Melen, CFO
+47 23 00 79 90 / +47 913 02 965 (mob)
Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.
Algeta’s lead product candidate, Alpharadin, is planned to enter Phase III clinical trials in hormone refractory prostate cancer before mid 2008 based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.
Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.
The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.
These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.