LEO Pharma Release: New Study Investigating The Effect Of Low-Molecular-Weight Heparins On The Treatment Of Blood Clots In Cancer Patients

THORNHILL, ON, Aug. 19, 2015 /CNW/ - The largest completed study  to date on treatments to reduce recurrence of blood clots in cancer patients, sponsored by LEO Pharma, has now been published in JAMA (The Journal of American Medical Association) August 18, 2015. 

The study showed that innohep® lowered the risk of recurrent venous thromboembolism (VTE) compared with warfarin with a significant reduction in symptomatic deep vein thrombosis and clinically relevant non-major bleeding in cancer patients with symptomatic venous thromboembolism.

Blood clots are one of the leading causes of death in patients with cancer.
Approximately 1 in 10 patients with cancer dies from a blood clot related event ^1,2.

"Cancer patients with VTE have a substantial risk of blood clots, and optimal treatment to avoid recurrence is vital. Advancing knowledge within this area is therefore a high priority for us at LEO Pharma. We hope that the results from the CATCH study will help to further improve the management of blood clots in cancer patients" says Kim Kjoeller, Senior Vice President from LEO Pharma.

According to Xavier Bertin, President & CEO of LEO Pharma Canada, "The results of this contemporary study support the current Canadian Consensus Recommendations³ and demonstrate the safety of full dose innohep® over a six month period".

Despite clinical practice guidelines recommending the use of low-molecular-weight heparins (LMWH) like innohep®, warfarin remains a frequently used anticoagulant treatment worldwide for cancer patients with recurrent VTE³. The CATCH study sponsored by LEO Pharma supports the previous findings and the clinical practice guidelines.

The CATCH study is a Phase III, multinational, concealed, randomised, active-controlled, open-label trial with blinded adjudication. 900 cancer patients from Europe, Africa, Asia, North America and South America were enrolled in the study. 449 patients were treated with tinzaparin (innohep®) and 451 were treated with warfarin over a period of 180 days.

During the treatment period, 7.2% of the patients treated with innohep® experienced recurrent blood clots compared to 10.5% of the patients treated with warfarin.

Dr. Agnes Lee, MD, University of British Columbia and Vancouver Coastal Health in Canada and Principal Investigator of the CATCH study commented: "This global study reinforces clinical guidelines supporting the use of low-molecular-weight heparins instead of warfarin to prevent recurrent blood clots in these patients. Our results also offer the first look at other important issues in this high-risk population, including identification of biomarkers that may predict for higher risk of recurrent blood clots, quality of life and health care economics".

Notes to editors

About innohep®

innohep® is a low-molecular-weight heparin (LMWH) for subcutaneous injection for the treatment of venous thrombosis and thromboembolic disease including deep vein thrombosis (DVT) and pulmonary embolism (PE). innohep® is manufactured by LEO Pharma.

About the CATCH study

CATCH is the largest randomized study conducted to date on extended treatment with LMWH to prevent recurrence of VTE in patients with active cancer⁴. CATCH is a Phase III, multinational, concealed, randomised, active-controlled, open-label trial with blinded adjudication assessing the efficacy and safety of long-term (6 months) innohep® (tinzaparin sodium) therapy (175 IU/kg) versus anticoagulation with warfarin for the treatment of VTE in 900 cancer patients. For further information please refer to the design paper published in BMC Cancer 2013, 13:284 by Lee et al., the primary publication in JAMA 2015;314(7):677-686 or www.clinicaltrials.gov website (identifier: NCT01130025).

About Cancer Associated Thrombosis

For the general population, the standard treatment for acute VTE consists of initial therapy with a low-molecular-weight heparin (LMWH) followed by longer-term treatment (36 months) with an oral vitamin K antagonist (VKA). Although this approach can be effective for many patients, cancer patients have a substantial risk of recurrent VTE. Several studies have reported incidences of recurrent VTE as high as 20% in patients with cancer^5,6. However, studies on how to treat and identify those at risk of recurrent VTE are limited^7,8. Moreover, the frequent monitoring and dose adjustments required for VKA treatment have a negative impact on Quality of Life⁹.

Guidelines in Europe and North America recommend long-term treatment of symptomatic VTE in all cancer patients^10,11,12,13. The major treatment objective is to reduce recurrent thrombosis, including fatal and non-fatal PE.

About LEO Pharma

Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company. LEO Pharma develops, manufactures and markets pharmaceutical drugs to thrombotic and dermatologic patients in more than 100 countries globally. The company has its own sales force in 61 countries and employs around 4.800 people worldwide. LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation.

For more information about LEO Pharma, please visit www.leo-pharma.com.

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References

1.Gussoni G, Frasson S, La Regina M et al. Three-month mortality rate and clinical predictors in patients with venous thromboembolism and cancer. Findings from the RIETE registry. Thromb Res 2013;131:24-30.

2. Khorana AA, Francis CW, Culakova E et al. Thromboembolism is a leading cause of death in cancer patients receiving outpatient chemotherapy. J Thromb Haemost 2007;5:632-634.

3. Lee et al. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients BMC Cancer 2013, 13:284

4. Easaw JC, Shea-Budgell MA, Wu CM, Czaykowski PM, Kassis J, Kuehl B, et al. Canadian consensus recommendations on the management of venous thromboembolism in patients with cancer. Part 2: treatment. Current oncology. 2015;22(2):144-55.

5. Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Büller HR: Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis.J Clin Oncol 2000, 18:3078-3083.

6. Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A: Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood 2002, 100:3484-3488.

7. Carrier M, Le Gal G, Cho R, Tierney S, Rodger M, Lee AY: Dose escalation of low molecular weight heparin to manage recurrent venous thromboembolic events despite systemic anticoagulation in cancer patients. J Thromb Haemost 2009, 7:760-765.

8. Lee AY: Anticoagulation in the treatment of established venous thromboembolism in patients with cancer. J Clin Oncol 2009, 27:4895-4901.

9. Noble SI, Finlay IG: Is long-term low-molecular-weight heparin acceptable to palliative care patients in the treatment of cancer related venous thromboembolism? A qualitative study. Palliat Med 2005, 19:197-201.

10.  Lyman GH, et al. ASCO Update. J Clin Oncol. 2013;31:2189-204

11. Streiff MB, et al. NCCN Clinical Practice Guidelines in Oncology for Venous Thromboembolic Disease. JNCCN 2011;9:714777

12. Kearon C, et al. 9th ACCP Guidelines. Chest. 2012;141(2_suppl):e419S-e494S

13. Mandala M et al. Management of Venous Thromboembolism (VTE) in Cancer Patients: ESMO Clinical Practice Guidelines. Ann Oncol 2011: 22 (Suppl 6) vi85-vi92

SOURCE LEO Pharma Inc.