March’s top stories: Novartis’ Phase III study, Boehringer’s Respimat trial

31st March 2014 (Last Updated March 31st, 2014 18:30)

Novartis' Phase III study of Jakavi met its primary endpoint of maintaining haematocrit control without the need for phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea while Boehringer reported positive results from large-scale Phase III studies of Respimat inhaler. Drugdevelopment-technology.com wraps-up the key headlines from March 2014.

March’s top stories: Novartis’ Phase III study, Boehringer’s Respimat trial
Blood smear from a patient with polycythemia vera. Photo: courtesy of Patho.

Boehringer

Novartis' Phase III study of Jakavi in polycythemia vera meets primary endpoint

Novartis

Novartis announced that the Phase III study of Jakavi (ruxolitinib) has met its primary endpoint of maintaining haematocrit control (red blood cell volume) without the need for phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea.

The pivotal, randomised Phase III study (RESPONSE) showed that the safety profile of ruxolitinib was genrally consistent with previous studies based on initial review of the data.

The open-label study was conducted at 109 sites and 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea were randomised 1:1 to receive either ruxolitinib (10mg twice-daily) or best available therapy that was defined as investigator selected monotherapy or observation only. Dose was adjusted as needed throughout the study.

Boehringer releases positive Phase III trial results of tiotropium Respimat in asthma patients

Boehringer

Boehringer Ingelheim reported positive results from large-scale Phase III studies demonstrating that once-daily tiotropium delivered via the Respimat inhaler was effective and well-tolerated in patients across asthma severities.

The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2014 annual meeting in San Diego, US.

The first results from the Phase III GraziaTinA-asthma trial showed that tiotropium Respimat improved lung function and was well-tolerated in patients with asthma who remain symptomatic, while receiving low-dose maintenance ICS treatment.

Janssen to start Phase III trial of daratumumab for treatment of myeloma patients

Denmark-based biotechnology firm Genmab announced that its partner, Janssen Biotech (Janssen) will initiate a Phase III trial of daratumumab for treatment of patients with relapsed or refractory multiple myeloma (MM).

Around 500 patients who have relapsed or refractory MM will be enrolled in the Phase III trial, which will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.

Patient enrolment is scheduled to start in the coming months and the primary endpoint of the trial is progression free survival (PFS).

Kamada completes patient enrolment in Phase II/III study of rabies vaccine KamRAB

Israel-based Kamada completed patient enrolment in its US Phase II/III clinical trial of KamRAB as a post-exposure prophylaxis (PEP) treatment for rabies.

KamRAB is the company's human rabies immune globulin, being marketed for this indication in six countries across the world.

Kamada and Kedrion have already entered into a strategic agreement for the clinical development and marketing of KamRAB in the US.

Omeros announces positive data for human monoclonal antibody OMS721

Omeros

Omeros reported positive data using OMS721 in ex vivo studies of endothelial activation relevant to the pathophysiology of human atypical haemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA).

OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system.

TMAs are a family of debilitating and life-threatening disorders characterised by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.

Pfizer's Phase III study of lung cancer drug Xalkori meets primary objective

US-based pharmaceutical firm Pfizer released positive results of PROFILE 1014, a Phase III trial of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC).

The trial of crizotinib met its primary objective of significantly prolonging progression-free survival (PFS) in NSCLC patients when compared with standard platinum-based chemotherapy regimens.

The company said that PROFILE 1014 is the second positive global Phase III trial that evaluated Xalkori against chemotherapy, a standard of care for patients with advanced NSCLC.

Arrowhead starts dosing patients in Phase IIa trial of hepatitis B drug ARC-520

Arrowhead

US-based biopharmaceutical firm Arrowhead Research started dosing patients in a Phase IIa clinical trial of its RNAi therapeutic ARC-520, for the treatment of chronic hepatitis B virus (HBV) infection.

Sixteen chronic HBV patients will be enrolled in the trial and they will be divided into two dose cohorts with patients receiving either ARC-520 or placebo in combination with entecavir.

The multi-centre, randomised, double-blind, placebo-controlled, dose-escalation Phase IIa trial is being conducted at Queen Mary Hospital and Prince of Wales Hospital in Hong Kong.

Abbvie begins Phase III trial of Humira to treat fingernail psoriasis

US drug maker AbbVie started a Phase III clinical trial designed to assess the use of Humira (adalimumab) as a treatment for fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis.

Psoriasis is a non-contagious, chronic immune disease that speeds the growth cycle of skin cells and results in thick, scaly areas of skin.

It can also affect the fingernails causing pitting, discoloration, loosening and irregular contour of the fingernail.

Portola begins Phase III trial of Factor Xa inhibitor reversal agent andexanet alfa

US-based Portola Pharmaceuticals started a Phase III trial designed to evaluate the safety and efficacy of its investigational Factor Xa inhibitor reversal agent 'andexanet alfa' with Bristol-Myers Squibb (BMS) and Pfizer's Factor Xa inhibitor Eliquis (apixaban).

The US FDA-designated breakthrough therapy 'andexanet alfa' is being developed as a potential first-in-class antidote to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are suffering a major bleeding episode or who require immediate surgery.

Portola is pursuing an Accelerated Approval pathway for andexanet alfa, which is the only agent that has showed reversal of the anticoagulation activity of Factor Xa inhibitors as measured by biomarkers, including anti-Factor Xa activity, in human studies.

GSK and Theravance reveal positive results from three Phase III trials in COPD

GlaxoSmithKline (GSK) and Theravance reported positive results from three Phase III trials comparing Anoro Ellipta with Seretide Diskus and Advair Diskus in patients with chronic obstructive pulmonary disease (COPD).

Out of the three, two trials compared the efficacy and safety of the combination anticholinergic / long-acting beta2-adrenergic agonist, Anoro Ellipta (umeclidinium/vilanterol, 'UMEC/VI') with inhaled corticosteroid / long-acting beta2-adrenergic agonist combination, Advair Diskus (fluticasone propionate/salmeterol 'FSC 250/50') in COPD patients.

The third compared the efficacy and safety of Anoro Ellipta with Seretide Diskus 'FSC 500/50' in patients with COPD and no history of moderate to severe COPD exacerbations in the last year.