Detailed results from ALSYMPCA phase III study highlight the positive impact of Alpharadin (radium-223 chloride) on skeletal related events associated with bone metastases from castration resistant prostate cancer

OSLO, NORWAY (Press Release) - February 1, 2012 -

Alpharadin data shows delay to spinal cord compression, pathological fractures and need for palliative radiation for bone pain, as well as improving overall survival

 


Algeta ASA announces that further data from the phase III ALSYMPCA study of Alpharadin (radium-223 chloride) will be presented at the 2012 Genitourinary Cancers Symposium* (2-4 February 2012, San Francisco, CA, USA).

Detailed analysis of the SRE data found that Alpharadin treatment significantly improved three out of four SRE components, as well as being associated with a 64% improvement in median time to first SRE of 13.5 months vs. 8.4 months for placebo (HR=0.610, p=0.00046). The three components of the SRE measurement that were significantly improved by Alpharadin vs. placebo were: time to spinal cord compression, time to pathological bone fracture and time to external beam radiation. These are summarized in the table below, and details of the presentations (abstracts #8 and #9) are provided later in this release.

 

No. (%) of Events Time to Event
(Ra-223 vs Placebo)
SRE Component Ra-223
N=541
Placebo
N=268
P value HR
(95%CI)
Pathologic Bone Fracture 20 (4) 18 (7) 0.013 0.45
(0.24-0.86)
Spinal Cord Compression 17 (3) 16 (6) 0.016 0.44
(0.22-0.88)
External Beam Radiotherapy 122 (23) 72 (27) 0.0038 0.65
(0.48-0.87)
Surgical Intervention 9 (2) 5 (2) 0.69 0.80
(0.27-2.4)

 

The appearance of SREs predicts a poor prognosis in CRPC patients with bone metastases, leading to pain, a decrease in quality of life and hospitalization. Spinal cord compression can be devastating for patients as it can cause paralysis, as well as bladder and bowel dysfunction.

Commenting on these results, Dr. Oliver Sartor said: "We have already seen the effect on overall survival with Alpharadin but these improvements in time to first SRE, particularly the significant reduction in time to spinal cord compression which we believe is the first time such data has been shown in CRPC patients, are noteworthy. Alpharadin is an effective therapy with a well-tolerated safety profile and may provide a new standard of care for treatment of CRPC patients with bone metastases."

Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, added: "The phase III ALSYMPCA study has now clearly shown the positive impact that Alpharadin has on both overall survival and the development of SREs in CRPC patients with bone metastases, an important quality of life indicator. Together, these new data reinforce our confidence in the potential of Alpharadin to become an important treatment for this symptomatic patient population, which currently lacks effective therapeutic options."

 

Details of the Presentations

Poster title: Abstract #9: Radium-223 chloride impact on skeletal-related events in patients with castration-resistant prostate cancer (CRPC) with bone metastases: A phase III randomized trial (ALSYMPCA).

Presenter: Oliver Sartor (Tulane Cancer Center, New Orleans, LA, USA), the lead investigator for ALSYMPCA in the United States.

  • Thursday, 2 February 2012
  • General Poster Session A
  • 11:45am-1:45pm

 

Presentation title: Abstract #8: Overall survival benefit and safety profile of radium-223 chloride (Alpharadin), a first-in-class alpha-pharmaceutical: Results from a phase III randomized trial (ALSYMPCA) in patients with castration-resistant prostate cancer (CRPC) with bone metastases.

Presenter: Christopher Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK), the ALSYMPCA study's principal investigator.

  • Thursday, 2 February 2012
  • Oral Abstract Session: Prostate Cancer
  • 1:15pm-3:05pm

 

Copies of the poster and presentation will be made available at www.algeta.com after the respective sessions.

*The 2012 Genitourinary Cancers Symposium is being co-sponsored by three leading medical specialty societies, including the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).


ALSYMPCA Study Design

The ALSYMPCA trial (ALpharadin in SYMptomatic Prostate CAncer patients) is an international, double-blind, randomized (2:1), placebo-controlled phase III clinical study evaluating Alpharadin plus best standard of care compared with placebo plus best standard of care in patients with CRPC and symptomatic (painful) bone metastases. The study treatment consisted of up to six intravenous administrations of Alpharadin or placebo, each separated by an interval of four weeks. The study recruited 921 patients, who were docetaxel ineligible or intolerable or had failed prior docetaxel therapy, at 136 centers in 19 countries.

The primary endpoint of the study is overall survival. Secondary endpoints include time to occurrence of SREs, changes and time to progression in PSA and ALP, safety, and impact on quality of life measures.

 

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in developed countries including the United Kingdom and the United States (other than skin cancer), and the incidence rate continues to rise. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men.

CRPC is also known as hormone-refractory prostate cancer (HRPC). The majority (up to 90%) of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to bone pain, fracture and other complications that can significantly impair a man's health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of disability and death in patients with CRPC.

 

###

 

For further information, please contact:

Algeta ASA:
Mike Booth
Communications & Corporate Affairs
+47 2202 4510

International media enquiries:
Mark Swallow
Citigate Dewe Rogerson
+44 207 638 9571

US investor enquiries:
Jessica Lloyd
The Trout Group
+1 646 378 2928

 

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

Algeta's lead product Alpharadin (radium-223 chloride) is in development as a potential new treatment for cancer patients with bone metastases. It is in pre-registration for castration-resistant prostate cancer (CRPC) patients with bone metastases, and filings are expected mid-2012 in the USA and Europe; Alpharadin has Fast Track designation for this indication in the USA.

Alpharadin is also under clinical investigation in breast cancer patients with bone metastases and in combination with docetaxel chemotherapy in CPRC patients with bone metastases.

Alpharadin is being developed and will be commercialized, pending approval, under a global agreement with Bayer Pharma AG.

Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a future pipeline of tumor-targeting alpha-pharmaceutical candidates.

The Company is headquartered in Oslo, Norway, and is listed on the Oslo Stock Exchange (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.


Algeta ASA


[ PRESS RELEASE ]

 

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