Algeta to Enroll US Patients Into Global Phase III ALSYMPCA Trial Following Successful End-of-Phase II Meeting With FDA
- ALSYMPCA Study Designed to Evaluate Alpharadin for the Treatment ofBone Metastases in Prostate Cancer Patients
Algeta ASA (OSE: ALGETA), the cancer therapeutics company, announces thatit is to enroll US patients into its ALSYMPCA phase III trial evaluatingAlpharadin as a new treatment for bone metastases in patients withhormone-refractory prostate cancer (HRPC). This decision follows a successfulend-of-phase II meeting* with the US Food and Drug Administration (FDA), heldon 30 January 2009.
Algeta began enrolling patients for its global phase III ALSYMPCA(ALpharadin in SYMptomatic Prostate CAncer) study in June 2008 and aims toenroll approximately 750 HRPC patients with bone metastases. Recruitment ofUS patients into the study is now planned to commence this year.
Alpharadin (radium-223) is Algeta's lead clinical candidate and hasdemonstrated in phase II studies strong evidence that it can prolong patientsurvival times, improves quality of life and offers a placebo-like safetyprofile.
These exciting clinical results combined with Alpharadin's uniquebone-targeting properties highlight the potential of this novel cancertherapeutic to be an important new treatment for bone metastases thatfrequently arise from a number of high incidence cancers as well as HRPC(e.g. breast, lung and kidney). Bone metastases are a serious consequence ofcertain advanced cancers causing intractable and debilitating pain as well asfurther reducing life expectancy.
Andrew Kay, Algeta's President and CEO, said: "Our recent and previousdiscussions with FDA have been productive and we believe they havecontributed positively to the overall clinical development plan forAlpharadin. We are therefore extremely pleased to enroll US patients into ourpivotal ALSYMPCA study following the successful end-of-phase II meeting withthe FDA. We will be focusing on initiating the study at key clinical centersin the US over the coming months."
ALSYMPCA phase III clinical study
The ALSYMPCA study is a double-blind, randomized, controlled trial thatenrolls symptomatic HRPC patients who will be randomized to receiveAlpharadin plus best standard of care or placebo plus best standard of care.
The primary efficacy endpoint of the trial is overall survival. Patientsare being randomized 2-to-1 in favor of Alpharadin, which will be given assix injections of 50 kBq/kg body weight, four weeks apart. Secondaryendpoints include time to occurrence of specified disease-related events, andtime to progression of certain key biomarkers indicative of disease status,including blood levels of serum prostate-specific antigen (PSA) and totalalkaline phosphatase (ALP). In addition, the trial will monitor and evaluateboth the acute and long-term safety profiles of Alpharadin treatment as wellas its impact on quality of life.
For more information on the ALSYMPCA trial, please go tohttp://www.algeta.com and click on the ALSYPMCA link in the menu bar.
Algeta ASA is a cancer therapeutics company built on world-leading,proprietary technology. Algeta is developing new, targeted cancertherapeutics that harness the unique characteristics of alpha particleemitters and are potent, well-tolerated and convenient to use.
Algeta's lead product candidate, Alpharadin (based on radium-223), hasblockbuster potential for treating bone metastases arising from multiplemajor cancer types, owing to its bone-targeting nature, potent efficacy(therapeutic and palliative) and benign, placebo-like safety profile.Development of Alpharadin is most advanced targeting bone metastasesresulting from hormone-refractory prostate cancer (HRPC), and it entered aninternational phase III clinical trial (ALSYMPCA) in mid-2008 based oncompelling clinical results from a comprehensive phase II program.
Algeta's strategy is to launch Alpharadin as a first or second linetreatment for cancer patients with bone metastases either alone or incombination with current standard of care therapies, thereby maximizing itscommercial potential.
Algeta is also developing other technologies for delivering alphaemitters. These include microparticles, liposomes, and methods to enhance thepotency of therapeutic antibodies and other tumor-targeting molecules bylinking them to the alpha particle emitter thorium-227. The Company isheadquartered in Oslo, Norway, and was founded in 1997. Algeta listed on theOslo Stock Exchange in March 2007 (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
About Bone Metastases
Bone is the most common organ to be affected by metastatic cancer (Ref.1). Approximately 1.5 million cancer patients suffer from bone metastasesworldwide and there are some 300,000 new cases each year. Importantly,metastases may stay confined to the skeleton with subsequent morbidity andeventual death almost entirely due to skeletal complications and theirtreatment.
Some 80% of bone metastases are due to prostate and breast carcinomas.For these high incidence cancers, 65-75% patients with advanced disease willhave bone metastases (Ref. 2). They may suffer multiple skeletalcomplications over several years because the clinical course of metastaticbone disease is relatively long. The effects are often debilitating(intractable bone pain, fractures, hypercalcaemia, and spinal cordcompression) and profoundly impair a patient's quality of life.
Bone metastases also occur frequently in patients with lung, kidney andthyroid cancers - respectively in 30-40%, 20-25% and 60% of patients withadvanced disease.
Current treatments for skeletal metastases are largely palliative. Theyinclude opioid analgesics, external beam radiotherapy, beta-emittingradionuclides and bisphosphonates.
1. Coleman, R.E. Clinical features of metastatic bone disease and risk ofskeletal morbidity. Clin Cancer Res. 2006;12:6243s-6249s. Review
2. Rubens, R.D, and Coleman, R.E. Bone Metastases. In: Abaloff, M.D.,Armitage, J.O., Lichter, A.S. and Niederhuber, J.E. Clinical Oncology 1995:643-665
This news release contains forward-looking statements and forecasts basedon uncertainty, since they relate to events and depend on circumstances thatwill occur in the future and which, by their nature, will have an impact onresults of operations and the financial condition of Algeta. There are anumber of factors that could cause actual results and developments to differmaterially from those expressed or implied by these forward-lookingstatements. Theses factors include, among other things, risks associated withtechnological development, the risk that research & development will notyield new products that achieve commercial success, the impact ofcompetition, the ability to close viable and profitable business deals, therisk of non-approval of patents not yet granted and difficulties of obtainingrelevant governmental approvals for new products.
* The purpose of an end-of-phase II meeting is to determine the safety ofproceeding to Phase III, to evaluate and the adequacy of current studies andplans to assess safety and effectiveness, and to identify any additionalinformation necessary to support a marketing application for the uses underinvestigation.For further information, please contact Andrew Kay, President & CEO +47-23-00-67-42 / +47-48-40-13-60 (mob) 0ystein Soug, CFO +47-23-00-79-84 / +47-906-56-525 (mob) email@example.com For international enquiries: Dr. Mark Swallow / David Dible / Helena Galilee Citigate Dewe Rogerson +44-207-638-9571 / +44-7903-737703 firstname.lastname@example.org
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