|By PR Newswire||
|September 11, 2012 06:09 AM EDT||
SEATTLE, September 11, 2012 /PRNewswire/ --
First and only approved therapy for this patient population
Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced the initiation of the commercial launch of Pixuvri® in the European Union ("E.U.") with entry into Sweden, Denmark and Finland in September, to be followed by Austria and Norway in early October 2012 and Germany, United Kingdom and the Netherlands in November 2012. CTI plans to expand availability to France, Italy and Spain as well as other European countries in 2013. Pixuvri was granted conditional marketing authorization by the European Commission in May 2012 and is the first medicinal product licensed in the E.U. to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin Lymphoma ("NHL"). In the E.U., there are approximately 37,000 new cases of aggressive B-cell NHL every year.,
"Patients with late-stage aggressive NHL who are not eligible for, or who have not responded to, second line therapy, have very limited treatment options and a bleak outlook, with average survival of less than a year," commented Dr. Ruth Pettengell, Consultant Hemato-Oncologist at St George's Hospital, London and principal investigator of the Phase III EXTEND study. "The evidence for Pixuvri demonstrates improved efficacy over current treatment options, but without the cardiotoxicity of anthracyclines. By addressing this unmet need, Pixuvri is an important new treatment option for physicians treating this group of patients."
In the EXTEND (Expanding the reach of anthracyclines with piXanTronE in relapsed or refractory aggressive NHL Disease) study for Pixuvri, when compared with other active single-agent treatments, more patients on Pixuvri achieved a complete response or unconfirmed complete response, and also survived for longer before their disease progressed. Prior to the approval of Pixuvri there was no standard of care for treating patients who failed front line and second line therapy for aggressive B cell NHL. The EXTEND trial is the only randomized controlled clinical study in this patient population establishing the standard of care for this patient population.
"We are pleased to be able to offer the first meaningful treatment option for physicians treating those patients with multiply relapsed and refractory aggressive NHL," stated James A. Bianco, M.D., President and CEO of CTI. "CTI looks forward to making this innovative product available to healthcare providers across the European Union."
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 has demonstrated 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. Please refer to the Summary of Product Characteristics ("SmPC") for the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/community-register/html/h764.htm#ProcList.
CTI is currently accruing patients into a Phase 3 trial comparing pixantrone and rituximab with gemcitabine and rituximab in the setting of aggressive B-cell NHL. European sites will be participating in this study later this year.
Pixuvri is available in the E.U. through Named Patient Programs in those countries where it is not available commercially.
Pixuvri does not have marketing approval in the United States.
About Conditional Marketing Authorization
Similar 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 as determined by the assessment conducted by the European Medicines Agency. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorisation 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.
About Non-Hodgkin's Lymphoma
NHL is caused by the abnormal proliferation of lymphocytes, cells key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms-aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.
There are many subtypes of NHL, but aggressive B cell NHL is the most common and accounts for about 50% of NHL cases. After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease. Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50% are expected not to respond. For those patients who fail to respond or relapse following second-line treatment, treatment options are limited, and usually palliative only. Pixuvri is the first treatment to receive E.U. regulatory approval for treatment of patients with multiply relapsed or refractory aggressive B-cell NHL.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.CellTherapeutics.com.
Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_alert
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the market price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of Pixuvri include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Pixuvri in particular including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the U.S. Food and Drug Administration, that CTI may not market and commercialize Pixuvri in the E.U. as planned, that CTI may not launch Pixuvri in the E.U. this year as planned, that CTI may not be able to complete the PIX306 clinical trial of Pixuvri-rituximab compared to gemcitabine-rituximab in patients who have relapsed after 1 to 3 prior regimens for aggressive B cell NHL and who are not eligible for autologous stem cell transplant by June 2015 or at all as required by the EMA or have the results of such trial available by June 2015 or at all, that CTI may not be able complete a post-marketing study aimed at confirming the clinical benefit observed in the PIX301 trial, that the conditional marketing authorization for Pixuvri may not be renewed, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, that CTI's average net operating burn rate may increase and CTI's ability to continue to raise capital as needed to fund its operations in general, and, including, without limitation, competitive factors, technological developments, costs of developing, producing, and selling Pixuvri, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
- European Cancer Observatory, Cancer Fact Sheets, 2008
- Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
- Pettengell R, Coiffier B, Narayanan G et al. Lancet 2012. Published online May 30th 2012. DOI:10:1-16/S1470-2045(12)70212-7
- Cavalletti E, Crippa L, Mainardi P et al. Invest New Drugs 2007;25:187-95
- Hagemeister FB. Cancer Chemother Pharmacol 2002;49(suppl 1):S13-20
- Cavalletti E, Crippa L, Mainardi P et al. Invest New Drugs 2007;25:187-95
- Friedberg ASH Education Book 2011;1:498-505