WEALTH on WIRE

Cell Therapeutics (CTIC.O) suffered a setback on Monday as a U.S. advisory panel said the company had not collected enough data to win clearance for an experimental lymphoma drug.

Today was the doom day for may CTIC  investors.  Two decade old company had half a billion market capitalization a few days back.  

Advisers to the Food and Drug Administration, in a 9-0 vote, said the company’s single trial of pixantrone was inadequate to back marketing approval.

“I don’t see this as being a well-designed or well-executed study,” said Dr. Wyndham Wilson, a panel member and a lymphoma specialist at the National Cancer Institute.

Shares of Cell Therapeutics lost 44 cents, or 48 percent, to close at 47 cents Monday. Trading had been halted until the early afternoon. The stock has ranged between 11 cents and $2.23 over the last year. Shares had been halted ahead of the panel vote.

The panel decision makes it unlikely the FDA will approve pixantrone without additional data. The agency usually follows panel recommendations, and FDA scientists who spoke to the committee also were critical of the company’s study.

Cell Therapeutics wants to sell pixantrone under the name Pixuvri for treating non-Hodgkin’s lymphoma that has stopped responding to other treatments. The blood cancer affects about 66,000 Americans annually.

The company said pixantrone offered an effective therapy for patients whose cancer worsened after at least two prior chemotherapy regimens. Patients at that stage have no approved treatments and often live less than six months.

In the Cell Therapeutics study of 140 patients, 20 percent had a major decrease in their disease if they got pixantrone, compared to about 6 percent with a different medicine.

“It is clear to me pixantrone provides an important benefit in these very poor prognosis patients,” said Dr. John Leonard, a cancer specialist at Weill Cornell Cancer Center and a Cell Therapeutics consultant.

But FDA reviewers questioned the company’s conclusions. They said the study tested less than half the number of people originally planned and included just eight U.S. patients. The agency also said heart damage and decreased white blood cells were more common with pixantrone versus other cancer drugs.

Despite their concerns, several panel members said they saw signs the drug could be helpful and urged additional study.

“This drug has some activity. I don’t think anybody on this committee would debate that point. The population enrolled in this study, however, doesn’t reflect the U.S. population of lymphoma patients,” said Dr. Mikkael Sekeres, an oncologist at the Cleveland Clinic.

In a statement after the panel vote, Cell Therapeutics Chief Executive James Bianco said the company was “committed to working closely with the FDA to address the committee’s comments as quickly as we can.”

“We continue to believe that pixantrone should be considered as a treatment option for patients” with aggressive NHL, he said.

The FDA is scheduled to make a decision on the drug by April 23. Swiss drugmaker Novartis (NOVN.VX) has an option for a worldwide license to develop and sell the drug.

New FDA date for reviewing pixantrone of Cell Therapeutics is March 22.  The earlier scheduled meeting was cancelled due to severe winter weather in February.

In advance of the postponed advisory panel meeting, the FDA issued a critical review of pixantrone, highlighting numerous concerns about pixantrone’s safety and efficacy.

Shares of Cell Therapeutics were down 10% to 60 cents Monday after auditors attached a “going concern” letter to the company’s 10-K annual report filed with the Securities and Exchange Commission Friday.  For the investor, if the drug works and gets approval, auditors concern doesn’t matter.  But what if the drug fails to get an approval?

Other drug of Opaxio as a treatment for lung cancer is irrelevant as better alternatives are already in the market.  So  Pixantrone approval is very critical to the company. 

Cell Therapeutics’ total share count reached more than 615 million at the end of January, compared to 296 million shares at the end of January 2009, according to SEC filings.  Whereas, in 2009, the top five Cell Therapeutics executives earned $32 million in total compensation, most of which came in the form of company stock awards.  A classic case of Executives feasting on investors money.