|AstraZeneca And Pharmacyclics Enter Clinical Trial Collaboration To Evaluate IMBRUVICA®; Covidien's HawkOne Directional Atherectomy System Receives FDA 510(K) Clearance|
|By Josh Gee|
|Tuesday, 04 November 2014 20:32|
Pharmacyclics (NASDAQ: PCYC) announced they have entered into a clinical trial collaboration to evaluate novel combination therapies targeting a number of hematologic cancers. The collaboration will explore separate combinations of two different AstraZeneca investigational PI3 kinase pathway inhibitors in combination with IMBRUVICA® (ibrutinib), Pharmacyclics' oral Bruton's tyrosine kinase inhibitor, for the treatment of patients with relapsed or refractory Diffuse Large B-cell Lymphomas. Preclinical evidence suggests that the combination of IMBRUVICA with these investigational medicines may enhance their effects.
Under the terms of the agreement, AstraZeneca and Pharmacyclics will collaborate on a non-exclusive basis and multiple studies may be considered and conducted. The studies will be led by AstraZeneca.
The Phase I element of each study is expected to establish a recommended safe and tolerable dose and schedule for the combination, and the Phase IIa element will assess its safety and efficacy in an expanded patient population. The financial terms of the agreement have not been disclosed. The results of the clinical studies will be used to determine whether further clinical development of the different combinations is warranted.
Susan Galbraith, Head of AstraZeneca's Oncology Innovative Medicines Unit said, "There is a clear and significant unmet need in the treatment of hematologic malignancies, an area of increasing focus for AstraZeneca. Our partnership with Pharmacyclics will allow us to explore new and potentially potent treatment combinations, which could have a positive impact on patient outcomes."
"We are optimistic that combining our oral once-per-day IMBRUVICA with other agents has the potential to enhance efficacy and duration across the landscape of hematologic cancers," said Bob Duggan, Chairman & CEO, Pharmacyclics.
IMBRUVICA is being developed and commercialized jointly by Pharmacyclics and Janssen Biotech, Inc.
Covidien plc (NYSE: COV) announced U.S. FDA 510(k) clearance for the HawkOne™ directional atherectomy system. The latest addition to Covidien's directional atherectomy portfolio, the HawkOne™ system provides physicians with an enhanced cutting mechanism to more effectively treat the widest variety of plaque in patients with peripheral arterial disease (PAD).
PAD affects more than 202 million people worldwide1 and more than 10 million people in the U.S.2 It occurs when arteries in the legs become narrowed or blocked by plaque, and it can cause severe pain, limited physical mobility and non-healing leg ulcers. PAD can also lead to serious health consequences such as amputation, cardiovascular disease and death.
“Covidien is committed to being the clear first choice for our physician and hospital partners by delivering new innovative technologies that help save and improve patient lives,” said Brian Verrier, president, Peripheral Vascular, Covidien. “The FDA clearance of the HawkOne™ system enhances our leading peripheral vascular portfolio and further demonstrates Covidien's leadership in the atherectomy space.”
Covidien's directional atherectomy portfolio includes the TurboHawk™ and SilverHawk™ systems and is backed by more than 15 peer-reviewed studies. Recent published data from the DEFINITIVE LE study in the Journal of American College of Cardiology, Cardiovascular Interventions demonstrated 95 percent limb salvage in patients with critical limb ischemia (CLI) and 78 percent overall patency (the ability for the treated artery to remain open) in claudicant patients at 12 months following treatment with directional atherectomy.
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