Cell Therapeutics… The Pixantrone Fight Continues (CTIC)
Cell Therapeutics, Inc. (NASDAQ: CTIC) is in the news again, and not just over its special meeting of shareholders. In the middle of the night, Cell Therapeutics announced that the company has received a Complete Response Letter from the FDA over its new drug application for Pixuvri (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin’s lymphoma. This is a battle in a war that looks far from being over.
The FDA cited as its primary reason for the action its concerns previously raised at the Oncologic Drugs Advisory Committee meeting on March 22, 2010 and recommended the company conduct an additional trial to demonstrate the safety and effectiveness of its product.
The company said further that, based on the FDA’s ODAC presentation, it has decided to pursue expanded access program for pixantrone while it conducts an additional study in aggressive non-Hodgkin’s lymphoma.
It now expects enrollment in a follow-up combination therapy study in a similar population could be rapid and occur predominantly within the U.S. and it has had preliminary discussions on the subsequent trial design with a leading statistician, and potential lead investigators who believe the study will be positively received by the lymphoma treatment community. That was noted as being “on the basis of the PIX 301 clinical trial results and the lack of satisfactory alternative therapies for their patients with multiple relapsed aggressive non-Hodgkin’s lymphoma.”
The company further noted that this is a sad outcome for its patients with relapsed/refractory aggressive NHL and it noted disappointment that the FDA “would ignore clinically meaningful improvements in overall response rate and progression-free survival, let alone complete responses….”
Cell Therapeutics plans to request a meeting with the FDA on both the design of the follow-on study as well as expanded access program for patients who are not participating in the company’s clinical trial. Later this month, it plans to meet with its clinical expert and the co-rapporteurs as it prepares to submit its Marketing Authorization Application to the European Medicines Agency for review. Based on their feedback and guidance, the Company expects to submit the application in the third quarter of 2010.
What is interesting here is that this is another true fight. The company’s version of statistically significant is different than the FDA’s version. This is also for relapsed or refractory aggressive non-Hodgkin’s lymphoma, which is far from the company trying to get a “first line of defense” or primary treatment status.
This stock battle of bulls and bears appears to be far from over. The company recently raised capital and is set for its special meeting of shareholders. The market is far from open, but the initial indications show the stock trading up at $0.66 versus a $0.637 close on Thursday.
Stay tuned.
JON C. OGG
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