I was surprised to read your opinion and inaccurate conclusions on the phase III results of our pixantrone pivotal study in relapsed aggressive NHL. In our PIX 301 study a data safety monitoring board containing a cardiologist who is the world authority on cardiotoxicity of chemotherapy drugs serially reviewed safety data during the study and found no issues that suggested consequential differences in cardiac toxicity between the two study arms. It is inaccurate to conclude that a small numerically higher incidence of serious cardiac adverse events of diverse types is a result of a drug’s toxicity to the heart as opposed to “cardio-vascular” system clinical symptom presentation which may include indirect consequences to the cardiovascular system. Such cardiac events could be results of tumor invasion of the heart which is quite common in lymphoma, as a consequence of infections with hypotension which are quite common during treatment of late stage disease or events unrelated such as myocardial infarctions or arrhythmias. All fall under what would be classified as a serious cardiac adverse events even though the event is not a direct effect of the drug on the heart but rather results from preexisting diseases or unrelated untoward events. Once the full data is presented at ASCO, perhaps you will have a better understanding of why we think your interpretation of these few events is highly misleading.

Given the important and highly significant benefit on both complete remission rates 20% vs 5.7% and prolonged median progression free survival 4.7 vs 2.6 months coupled with the fact this is the only randomized study to show such pronounced benefits in this relapsed population, your article serves a injustice to the thousands of patients with relapsed aggressive NHL who could benefit from pixantrone.

James A. Bianco, M.D.
Chief Executive Officer
Cell Therapeutics, Inc
501 Elliott Avenue
Suite 400
Seattle, WA 98119

Jack Singer, MD, Chief Medical Officer, Cell Therapeutics Inc.

Nancy Boman, MD, PhD, Vice President, Clinical Development and Regulatory Affairs, Cell Therapeutics Inc.