Drug Company: Pixantrone effective safe for advanced lymphoma

Lymphoma is a malignant neoplasm of the immune system and lymph nodes. Men and women aged 50 and above are more likely to develop this disease. With the increase in the frequency of non-Hodgkin’s lymphoma (NHL) during the past decade approximately 50 000 American people are suffering from this illness now. The exact cause of the disease is still unknown but certain viruses like EBV or HIV are responsible for some lymphomas. Though some lymphomas are curable many patients face refractory or recurrent disease.  Sometimes patients must endure multiple rounds of chemotherapy to achieve remission over time. The therapy of persistent disease will depend on disease manifestations and prior treatments. Most patients with refractory lymphoma are treated with chemotherapy. Radiation therapy may also be supportive in managing painful areas where the cancer has spread.  Treatments for refractory disease have traditionally been only marginally effective and many patients must endure aggressive treatments such as stem cell transplants to get a durable remission of their lymphoma once it returns. Cell Therapeutics Inc. (CTI) has announced early results of its Phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2778) for patients with advanced symptoms of non-Hodgkin’s lymphoma (NHL). Pixantrone directly modifies the structure of DNA and is an analogue of mitoxantrone with reportedly less toxic effects on cardiac tissue. It is being studied as an antineoplastic for different types of cancer including solid tumors and hematological malignancies such as non-Hodgkin lymphomas. The outcome of the just-concluded study (which was conducted at 130 sites in 17 countries) showed that patients who were treated with pixantrone attained a high rate of persistent and unconfirmed complete remissions compared to patients treated with standard chemotherapy (14/70 (20.0%) for pixantrone arm compared to 4/70 (5.7%) for the standard chemotherapy arm p = 0.02). No patient achieved a confirmed complete remission compared to 8/70 (11%) of pixantrone recipients in the standard chemotherapy arm. An independent data review committee confirmed remissions in this study.  Pixantrone also significantly increased the overall response rate with 37.1% reported for pixantrone arm compared to 10/70 14.3% for the control arm p = 0.003.  If confirmed these results are some of the most encouraging seen in this disease setting in quite a while.  The most common serious toxicities (>5%) seen in previous trials of pixantrone include grade 3 and 4 neutropenia and febrile neutropenia. CTI is expected to release additional details of the study and will provide complete safety and progression-free survival information comparing treatment assignments.  It is our hope here at InteractMD.com to see these results published in a peer-review setting and we therefore are critical of drug companies releasing their pivotal clinical trial results in press release format.  This seems to be the standard practice these days probably more for financial considerations than anything else.  Looks like Cell Therapeutics stock didn't take much of a bump despite these positive results.  They say individual drug results don't move stock prices much except Viagra and Pfizer so why can't Cell Therapeutics wait for a publication in a real journal to crow about results?