"We believe Marqibo as part of a multi-drug treatment regimen has the potential to improve the outcomes for patients with newly diagnosed Ph- ALL and we are pleased the HALLMARQ Study which is being conducted under an SPA has commenced enrollment," stated
About the HALLMARQ Study
Title: "A Phase 3, Multicenter, Randomized Study to Evaluate the Substitution of Marqibo (Vincristine Sulfate Liposome Injection, VSLI) for Standard Vincristine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Subjects ≥ 60 Years Old with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)."
Primary Objective: To compare overall survival (OS) among subjects 60 years of age and older with newly diagnosed ALL who receive Marqibo versus standard vincristine as a component of multi-agent induction, intensification, and maintenance chemotherapy. The study is powered for superiority.
Marqibo is a novel, targeted Optisome™ encapsulated formulation product candidate of the
Talon has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the
In addition to the HALLMARQ Study in front-line adult elderly ALL, Marqibo is being evaluated in an on-going Phase 3 trial in front-line adult elderly aggressive non-Hodgkin's lymphoma conducted by the German High Grade Non-Hodgkin's Lymphoma Study group, and in a Phase 1 trial in pediatric cancers, including ALL, being conducted by the
In addition to Marqibo, the Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the potential of Marqibo to improve outcomes for patients with newly-diagnosed PH- ALL and its ability to replace existing therapies in other indications, the timing of Talon's ongoing and planned clinical trials, and Talon's ability to obtain approval of its Marqibo NDA. Such statements involve risks and uncertainties that could cause Talon's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on
current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Such risks and uncertainties include: that there can be no assurances that any of Talon's clinical and regulatory development efforts relating to Marqibo will be successful; that Talon's NDA for Marqibo will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the
Talon Therapeutics, Inc.Investor & Media Contacts: (650) 588-6641 email@example.com
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