Distribution of company announcements to the professional platforms, finance portals and syndication of important corporate news to a wide variety of news aggregators and financial news systems.
Algeta ASA (OSL:ALGETA) Alpharadin - Phase III ALSYMPCA study in hormone-refractory prostate cancer patients now enrolling
Further efficacy data confirm effectiveness of Alpharadin in advanced prostate cancer
Oslo, Norway, 5 November 2008 - Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today announces its results for the third quarter 2008. A presentation to analysts, investors and the press will take place today in Oslo at 08:15 CET and a conference call will take place at 14:30 CET - details below.
The third quarter showed continued progress for Algeta, including the reporting of further important supportive phase II clinical data from the Alpharadin development program. Highlights of the third quarter 2008 include:
* Enrollment of patients for the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study is now ongoing in several countries in Europe, with an increasing recruitment rate as more clinical centers are opened to the study. The international trial is evaluating Algeta's targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton, with overall survival as the primary endpoint. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada.
* The primary objective of the BC1-03 phase II pain palliation study with Alpharadin was met. The study, which was designed to evaluate the effects of four different single dose levels of Alpharadin, showed that a single dose of Alpharadin provided pain relief. There was a clear dose-response effect, with higher doses providing better pain palliation. The control of pain is an important quality-of-life benefit in metastatic cancer patients. The trial also confirmed Alpharadin's benign side-effect profile including, importantly for a drug in this clinical setting, no significant bone marrow toxicity.
* During the quarter, Algeta completed the BC1-04 study, designed to explore the effects different Alpharadin dose levels. The company is conducting the final analysis of the data.
* The first US clinical trial for Alpharadin was started at the Memorial Sloan-Kettering Cancer Center in New York. The BC1-08 study is a phase I pharmacokinetics, biodistribution and dosimetry study being conducted in up to 18 HRPC patients. The first cohort of three patients has been treated and data are being analyzed before proceeding to the next cohort.
Key financials:
* Operating expenses for the third quarter 2008 amounted to NOK 39 million compared with NOK 21 million in the third quarter 2007 and NOK 56 million in the second quarter 2008. Operating expenses for the first nine months were NOK 133 million, compared to NOK 59 million in the corresponding period last year.
* Liquid funds amounted to NOK 154 million as of 30 September 2008, compared to NOK 210 million at the end of June 2008.
Commenting on Algeta's progress during the third quarter 2008, President and CEO Dr. Thomas Ramdahl, said: "Algeta continues to make good progress with the clinical development of Alpharadin for advanced prostate cancer and passed another major milestone with the start of our pivotal phase III study in June. We are now working hard to ensure that patients enrol into the study as quickly and as efficiently as possible. We are also very pleased with the positive phase II data from the BC1-03 and BC1-04 trials. These data reinforce the clinical data package that we have already assembled with Alpharadin, which demonstrates that Alpharadin treatment offers a significant survival benefit to hormone-refractory prostate cancer patients combined with a benign safety profile."
Presentation and conference call
A presentation to analysts, investors and press will take place today in Oslo at 08:15 CET and an international conference call will take place at 14:30 CET. Algeta's President and Chief Executive Officer, Dr. Thomas Ramdahl, and Chief Financial Officer Øystein Soug, will host the presentation and the call.
The presentation will take place at 08:15 CET at:
Hotel Continental Stortingsgaten 24/26 0117 Oslo Norway
Breakfast will be served from 07:45 CET.
To participate in the conference call, please dial the appropriate number below:
The third quarter 2008 results statement and the presentation will be made available from 08:00 CET November 5, 2008, on www.algeta.com in the Investors section. The full report also follows below.
A replay version of the call will be available until the presentation of results for the fourth quarter 2008. To access the replay, dial +47 67 89 40 91. Enter account no. 1428 followed by #, then press 1, conference no. 428 followed by #. Press 1 to play. A replay version of the conference call will also be available during the same period at www.algeta.com.
### For further information, please contact
Dr. Thomas Ramdahl, CEO +47 23 00 79 90 / +47 913 91 458 (mob) Øystein Soug, CFO +47 23 00 79 84 / +47 906 56 525 (mob) post@algeta.com
For international enquiries: +44 207 638 9571 Mark Swallow/Helena mark.swallow@citigatedr.co.uk Galilee/David Dible Citigate Dewe Rogerson
About Algeta 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, has commenced phase III clinical trials in hormone-refractory prostate cancer 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. 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.
Forward-looking Statement 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. Theses 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.
###
This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
