Preclinical Study Provides Potential Mechanisms For Lower Cardiotoxicity In Patients With Multiply Relapsed Or Refractory Aggressive B-cell NHL Treated With PixuvriTM Who Received Prior Doxorubicin Therapy

The publication by Salvatorelli E., et al., led by Professor Minotti G., titled "The novel anthracenedione, pixantrone, lacks redox activity and inhibits doxorubicinol formation in human myocardium; Insight to explain the cardiac safety of pixantrone in doxorubicin treated patients," is available at  http://jpet.aspetjournals.org/content/early/2012/12/03/jpet.112.200568.abstract

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds, Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

In May 2012, Pixuvri received conditional marketing authorization in the E.U. as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.   The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at  www.pixuvri.eu.

CTI is currently accruing patients into a Phase 3 trial comparing Pixuvri and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. 

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

The European Medicines Agency's (the "EMA") Committee for Medicinal Products for Human Use has accepted PIX306, CTI's ongoing randomized controlled phase III clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL  and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

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