The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

Start Date01 Mar 2010

Sponsor / Collaborator

Canyon Pharmaceuticals, Inc.

NL-OMON35683

/ CompletedPhase 2

Canyon-I-Pilot Trial a dose-ranging study of bolus-only Desirudin in patients undergoing PCI - CANYON-PCI pilot study

Start Date04 Sep 2009

Sponsor / Collaborator

Canyon Pharmaceuticals, Inc.

EUCTR2009-010903-98-BE

/ Not yet recruitingNot Applicable

A dose-ranging study of bolus-only Desirudin in patients undergoing PCI

Start Date20 Aug 2009

Sponsor / Collaborator

Canyon Pharmaceuticals, Inc.

100 Clinical Results associated with Canyon Pharmaceuticals, Inc.

0 Patents (Medical) associated with Canyon Pharmaceuticals, Inc.

Literatures (Medical) associated with Canyon Pharmaceuticals, Inc.

18 Nov 2011·Blood

VTE Prophylaxis with Desirudin in Patients with Thrombocytopenia: Insights From the DESIRABLE Trial,

Author: Key, Nigel S. ; Marder, Victor J. ; Levy, Jerrold H ; Shorr, Andrew F ; Kurz, Michael A

AbstractAbstract 3293Background:Prophylaxis for venous thromboembolism (VTEP) is recommended for critically ill patients with limited mobility or those undergoing major surgery. Commonly used agents are heparin-based therapies (unfractionated or low-molecular-weight heparin (H); fondaparinux) which are of limited utility in patients with thrombocytopenia (TCP) due to concerns about bleeding risk and the possibility of heparin-induced thrombocytopenia (HIT). The DESIRABLE trial was designed to examine the safety profile of desirudin (Iprivask®, recombinant hirudin), the only parenteral heparin alternative approved for VTEP in the US, in a broad range of perioperative and critically ill patients requiring VTEP. DESIRABLE was a multicenter, open-label, single-arm study which enrolled 516 subjects at 19 centers. Desirudin was administered for as long as clinically required at 15 mg Q12H SC. Patients with uncontrolled bleeding were excluded. The primary endpoint was Major Bleeding; secondary endpoints included incidence of new symptomatic VTE. The present analysis was performed to evaluate the safety profile of desirudin in DESIRABLE patients who were thrombocytopenic at enrollment.Methods:Case report forms were reviewed to identify subjects with TCP, defined as having a platelet count of <150 × 106/mL. Demographic characteristics, incidence of Major Bleeding, VTE, and serious adverse events were determined for comparison to the overall cohort.Results:Analysis of case report forms identified 93 subjects with TCP (<150 × 106/mL), 50 (54%) of whom had a platelet count <100 × 106/mL. Compared to subjects with normal platelet counts, TCP subjects were older (median age 66 vs. 59), more likely to be male (65% vs 34%) and underweight (BMI <25: 37% vs 23%), and less likely to be morbidly obese (BMI >35, 14% vs 31%). TCP subjects were also more likely to have a recent (<3 months or concurrent) history of cardiac surgery (CABG or valve, 24% vs 3%), coronary artery disease (47% vs 20%), congestive heart failure (18% vs 7%) and/or atrial fibrillation (16% vs 4%). HIT was suspected in 27 (29%) of TCP subjects, although the presence of HIT was not confirmed by SRA testing. No subjects had clinical evidence of thrombosis at enrollment. Treatment duration was similar between TCP subjects and the overall cohort (5.1±3.3 days vs 4.9±3.2 days, p=NS). The incidence of new VTE was similar between TCP and non-TCP subjects: 2 (2.2%) TCP subjects developed a VTE vs 6 of 423 non-TCP subjects (1.4%, p=NS). There were no bleeding events meeting criteria for the Primary Endpoint in either group. Serious adverse events occurred in 16 (17%) TCP subjects, all considered unrelated to study drug. Serious adverse events were reported in 64 (15%) non-TCP subjects, 5 of which were considered “possibly related” to study drug.Conclusions:DESIRABLE demonstrated the clinical utility and safety of desirudin in a broad population of critically ill perioperative and medical patients. The present subanalysis indicates that this finding holds true for hospitalized TCP patients, suggesting that desirudin may be a useful alternative for VTE prophylaxis patients for whom HIT is suspected or heparin-based therapies are considered inappropriate. Additional randomized trials in TCP patients are needed to confirm these findings.Disclosures:Levy: Canyon Pharmaceuticals: Consultancy. Off Label Use: Desirudin is approved for VTE prophylaxis following elective hip arthroplasty. Data presented may describe use of desirudin for VTE prophylaxis in patients who did not undergo total hip arthroscopy. Kurz:Canyon Pharmaceuticals: Employment. Marder:Canyon Pharmaceuticals: Clinical Trial Steering Committee.

10 Dec 2009·Molecular Cancer Therapeutics

Abstract C183: Antitumor efficacy of PEG-Hirudin (LU 87981), administered three times weekly, in an orthotopic AsPC-1 pancreas carcinoma model

Author: Schaechtele, Christoph ; Mueller, Iris ; Graeser, Ralph ; Fiedler, Ulrike ; Esser, Norbert ; Yu, Tony

AbstractBackground: Since anticoagulants could be shown as promising novel therapeutics in oncology, direct thrombin inhibitors like recombinant Hirudin (Revasc©/desirudin) were assessed in a preclinical orthotopic AsPC-1 mouse model in vivo. The challenges of desirudin for the treatment of cancer are its complex pharmacodynamics and a short half life (mean elimination half-life of 2–3h), requiring at least twice daily subcutaneous administration of the drug. PEG-Hirudin, the conjugate of recombinant Hirudin with two molecules of polyethylene glycol (PEG)-5000 represents a potential alternative to Revasc© with a longer half-life and more stable plasma levels. In order to test this compound, the pancreatic cancer cell line, AsPC-1 was chosen, for which preliminary results with Revasc© were available. AsPC-1 cells implanted orthotopically into the mouse pancreas reflect hallmarks of the human disease such as early invasion of the surrounding pancreatic tissue and the formation of metastases in the spleen and liver as well as the peritoneum.Material and Methods: Luciferase expressing AsPC-1 cells were orthotopically implanted into mouse pancrei. The growth of the tumors was followed via bioluminescence measurements (whole body imaging). 13 days after surgery, 12 animals each were randomized into 5 treatment groups according to their bioluminescence signal. Group 1 served as vehicle control receiving 100µl saline solution three times weekly s.c. from day 15 to day 38. The application scheme was comparable to treatment groups receiving 1mg/kg (group 3), 3 mg/kg (group 4) and 0.3mg/kg (group 5) PEG-Hirudin three times weekly s.c. starting at day 15. The animals of group 2 received Gemcitabin at 240mg/kg administered i.v. once weekly starting at day 15. At the end of the study tumor weight and volume were determined and luciferase activity was monitored in the primary tumor and selected organs (spleen, liver, stomach, intestine, lung and inguinal lymph nodes).Results: PEG-Hirudin was well tolerated, no bleeding at the injection site or other side effects could be observed. Only one animal of group 4 was found dead during the study, all other animals reached the end of the study. Gemcitabin, did not affect tumor growth according to in vivo bioluminescence imaging, whereas PEG-Hirudin at 1 and 3 mg reduced the increase of the bioluminescence signal during the treatment period significantly. Once the animals were sacrificed and tumor sizes measured, treatment with PEG-Hirudin at 1 and 3 mg/kg showed significant reduction of the average primary tumor size (Group 3: *p= 0.0129, Group 4:**p=0.0015). The positive control, Gemcitabin showed as well a significant antitumor efficacy (***p=0.0002). The differing results of in vivo imaging and primary tumor sizes are reflecting the different efficacy of the test items on primary tumor and peritoneal metastases.Conclusion: The results presented here suggest a promising anti-tumoral efficacy of the PEG-Hirudin compound. Due to its extended half-life and the resulting relaxation of the application scheme, PEG-Hirudin is a promising alternative to Revasc© (desirudin) in oncology.Citation Information: Mol Cancer Ther 2009;8(12 Suppl):C183.

10 Dec 2009·Molecular Cancer Therapeutics

Abstract C187: Antitumoral efficacy of the novel thrombin inhibitor Revasc©/Desirudin in an orthotopic metastatic AsPC-1 pancreas tumor model

Author: Schaechtele, Christoph ; Mueller, Iris ; Graeser, Ralph ; Fiedler, Ulrike ; Esser, Norbert ; Yu, Tony

AbstractBackground: Thrombo-embolism is one of the most common secondary diseases in cancer patients and is the second leading cause of death of these patients. In pancreatic cancer patients, thrombosis occurs more frequently than in other cancer patients. Thus anticoagulants are widely used in cancer therapies mainly to prevent the development of thrombo-embolisms. However there is increasing evidence that anticoagulants have also antitumoral and anti-angiogenic effects. The aim of this study was to evaluate the anti-tumoral, anti-metastatic and anti-angiogenic efficacy of the novel anticoagulant Revasc© a recombinant hirudin and direct thrombin inhibitor, in an orthotopic mouse model of pancreatic cancer.Material and Methods: To evaluate the anti-tumoral, anti-metastatic and anti-angogenic efficacy of Revasc©, luciferase labeled pancreatic AsPC-1-tumor cells were orthotopically implanted into the pancreas of NMRI nude mice. After onset of tumor growth, mice were randomized into six groups. Group 1 received vehicle control (0.9% NaCl) twice daily, Group 2 received Gemcitabine (240 mg/kg) once weekly; Group 3 received Revasc at a concentration of 1 mg/kg twice daily, Group 4 received Revasc© at a concentration of 3 mg/kg twice daily, Group 5 received Revasc© at a concentration of 10 mg/kg daily and Group 6 received a combination therapy of twice daily 10 mg/kg Revasc© plus a weekly dose of 240 mg/kg Gemcitabine. At the end of the study, tumor weight and volume were determined and luciferase activity was monitored in the primary tumor and selected organs (spleen, liver, stomach, intestine, lung and inguinal lymph nodes). In addition, microvessel densities and vessel maturation was determined by immunohistochemisty.Results: In general, Revasc© was very well tolerated. The primary tumor weight was significantly reduced in the groups receiving Revasc© at a concentration of 3 mg/kg and 10 mg/kg as well as in the control group treated with Gemcitabine. The combination of Gemcitabine and Revasc©, however, did not show any additive effect. No significant reduction of metastasis could be observed in the Revasc© Groups, whereas Gemcitabine efficiently inhibited metastasis into the lung. However, Revasc© showed a significant anti-angiogenic potential at the lowest concentration of 1mg/kg, corroborating findings of other groups showing that thrombin inhibition acts anti-angiogenic.Conclusion: Taken together the study showed that Revasc© has an anti-tumoral and a mild anti-angiogenic effect. The data suggest that Revasc© has a potential to be used for the treatment of patients with pancreatic cancers; primarily to prevent thromboembolism but secondarly also to inhibit tumor growth. It remains to be shown if Revasc will lead to a solid anti-tumoral effect in patients and if the relatively short mean elimination half life of Revasc© (2–3 h) will allow to identify a convenient dosing scheme. Alternatively a pegylated hirudin derivative (PEG-hirudin) which has a longer half life and which has proven to have a very efficient antitumoral activity could be of high therapeutic interest.Citation Information: Mol Cancer Ther 2009;8(12 Suppl):C187.

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