Press Release

Basel, October 27, 2005 – Roche has announced the start of the largest clinical research programme ever to investigate the use of their bisphosphonate Bondronat® for the relief of bone pain caused by metastatic bone disease, a severely debilitating condition which affects millions of cancer patients. The extensive research programme is designed to show superiority of Roche’s Bondronat (ibandronate) over another commonly used bisphosphonate, zoledronic acid (Zometa), in reducing the pain associated with this condition in terms of both magnitude and speed.

Metastatic bone disease commonly develops in the advanced stages of many cancers, including breast, prostate and lung cancer. Relief from the severe bone pain is a major goal for physicians as it can have a devastating impact on patients’ quality of life leading to immobility, sleep loss and an inability to continue with daily activities. Three out of four patients with metastatic bone disease experience bone pain and it is the main reason that patients seek medical care. Sadly, an estimated two thirds of these patients continue to experience moderate-to-severe bone pain despite treatment with current therapies like opioids.

The new trials have been planned following impressive results from earlier Phase II studies which showed that a unique loading dose of Bondronat achieved a significant reduction in bone pain within three days – this relief was sustained throughout the six month study duration when followed by oral or i.v. maintenance dosing of Bondronat at the regular schedule. The large loading dose required is possible with Bondronat due to its excellent renal safety profile – a benefit not possible with other bisphosphonates.

“This research programme could radically alter the treatment of bone pain and give cancer patients hope for relief from this debilitating condition” commented lead investigator Professor Jean-Jacques Body from the Institut Jules Bordet in Belgium. “We have already seen that cancer patients treated with Bondronat have experienced a remarkable reduction in pain from bone metastases, especially after the high dose therapy, and these trials will further our knowledge in the area.”

About the clinical research programme

Two randomised, placebo controlled studies will compare the efficacy of both oral and intravenous Bondronat versus intravenous zoledronic acid, in patients with skeletal metastases experiencing moderate to severe pain. Each of the two studies will commence with a loading dose of 6 mg i.v. Bondronat on three consecutive days followed by either i.v. or oral maintenance dosing at the regular schedule. Approximately 900 patients will take part in the six month study throughout Europe, Russia, North America, South America, and Australia, making it the largest research programme conducted in this area. Full data are expected in 2007.

Adult cancer patients with metastatic bone disease will be encouraged to enquire about the trials and may obtain further information by:

• contacting their healthcare professional
• contacting their local patient group
• visiting www.cancerbonepain.com ^{(see notes section for further information)}

Bisphosphonates and treatment of metastatic bone pain

Bisphosphonates are currently licensed to treat metastatic bone disease by reducing the risk of bone damage caused by cancer cells. Based on earlier findings, it is anticipated that the trials will demonstrate the efficacy of Bondronat in treating the bone pain caused by metastatic bone disease in patients with many different cancer types. Recent phase II results using the unique loading dose of Bondronat showed a significant reduction in bone pain within three days which was sustained for six weeks in one study using one loading dose of Bondronat and for six months in a study where Bondronat was administered every four weeks after the initial loading dose. Over 80% of patients in these studies showed a more than 3 points improvement in pain score as measured by the visual analogue scale (VAS 1-10). This is an unprecedented outcome, since bisphosphonates are commonly regarded as only providing moderate bone pain relief, usually requiring 2-3 months to achieve optimal results. Loading doses are not possible or practical with other bisphosphonates.  

About Bondronat

Bondronat was approved by the European Commission for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases in October 2003. Bondronat has shown in three randomized trials to be safe and effective for the prevention of skeletal related events as well as to reduce bone pain below starting levels for at least two years. A recently presented head-to-head study versus zoledronic acid also demonstrated comparable reductions in bone markers (surrogate measures for skeletal related events efficacy) in patients with metastatic bone disease.  The approved dosage of Bondronat for prevention of the complications of skeletal metastases in patients with breast cancer and bone metastases is 50 mg once daily or 6 mg administered intravenously every three to four weeks.

-Ends-

References

1.       Heidenreich A, Ohlmann C, Olbert P, Hegele A. High-dose ibandronate is effective and well tolerated in the treatment of pain and hypercalcemia due to metastatic urologic cancer. Eur J Cancer 2003;1(Suppl.):S270

2.       Yau V, Chow E, Davis L, et al. Pain management in cancer patients with bone metastases remains a   challenge. J Pain Symptom Manage 2004;27:1–3

3.       Clohisy DR, Mathyh PW. Bone cancer pain. Cancer 2003;97 (3 Suppl.):866–73

Notes to Editors:

www.bonepain.com

As a key source of information about the trial and metastatic bone pain, Roche has announced the launch of a new website, www.bonepain.com. The website provides patients with information about the condition and support materials designed to help patients describe their symptoms in a way that will enable healthcare professionals to deliver the most appropriate pain relief possible. The website also offers details of how patients can enrol in the clinical trial.

For further information about Roche in Oncology go to: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

For more information:
http://www.bonepain.com

Last updated on: 27/08/2010 11:40:18