CTI BioPharma Announces Completion of Enrollment in the Phase 3 PIX306 Trial of PIXUVRI® for Aggressive B-cell non-Hodgkin lymphoma

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Aug 02, 2017, 01:30 ET

SEATTLE, Aug. 2, 2017 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ and MTA: CTIC) today announced the completion of enrollment in the Phase 3 PIX306 trial of PIXUVRI® (pixantrone). The PIX306 trial is evaluating PIXUVRI combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). Patients eligible to be enrolled in the trial had failed front line CHOP-R and were not eligible for autologous stem cell transplant (ASCT) (2nd line) or failed ASCT (3rd or 4th line). PIXUVRI has previously been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL.ⁱ The trial is being conducted as a post-authorization requirement of conditional marketing authorization. If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.

About PIXUVRI (pixantrone)

PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells in B-cell NHL cannot divide and eventually die.ⁱⁱ

PIXUVRI is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit 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.servier.com.

About NHL

NHL is an uncommon type of cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.ⁱⁱⁱ The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.^iv

Around 93,500 new cases of NHL were diagnosed in Europe in 2012, making it the eleventh most common cancer on the continent.^v

NHL comprises more than 60 subtypes, with each requiring a different diagnostic evaluation and treatment approaches. Lymphoma patient groups around the world, led by the umbrella group Lymphoma Coalition, have been recently calling for accurate subtype reporting to allow patients to clearly understand their subtype and have better communication with their doctors. Given the complexities of the condition, access to information is essential to empower patients.

About CTI BioPharma Corp.

CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI BioPharma's securities. Such statements include, but are not limited to, expectations with respect to milestone and royalty payments, the expected benefits and potential of PIXUVRI, including with respect to results of the trial possibly expanding PIXUVRI into new indications. The statements are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to fully and carefully evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular including, among others, risks associated with the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality or patient safety issues; product development risks; the impact of competitive products and pricing and reimbursement; that CTI BioPharma cannot predict or guarantee the outcome of preclinical and clinical studies, as well as other risks listed or described from time to time in CTI BioPharma's most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.

ⁱ http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000925.jsp [last accessed March 2017]

ⁱⁱ http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed March 2017]

ⁱⁱⁱ NHS Conditions webpage. NHL cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed March 2017]

^iv Cancer Research UK. Lymphatic System. Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer [last accessed March 2017]

^v Cancer Research UK. Non-Hodgkin lymphoma incidence statistics. Available at http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/non-hodgkin-lymphoma/incidence#GCwFbl4szbj1GQxD.99 [last accessed March 2017]

CTI BioPharma Contacts:

Ed Bell
+1 206-272-4345
[email protected]

SOURCE CTI BioPharma Corp.