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CTI's Bianco: Controversial and complex CEO

Dr. James (Jim) Bianco, M.D., was an up-from-poverty son of Italian immigrants, just out of medical school in New York, when he was recruited by E. Donnall Thomas to come to the Fred Hutchinson Cancer Research Center to join its pioneering bone marrow transplantation team. The work of the team would bring Thomas a Nobel Prize for Medicine and launch some team members, including Bianco, on careers pursuing cures for cancer. Bianco has resigned suddenly from the company he founded in 1991 to find a cure for blood-related cancers. During more than a quarter century as chairman and CEO of what is now CTI Biopharma, he became one of the area's most intriguing CEOs, a complex and controversial leader praised by those who experienced his moral and philanthropic support and criticized by others who focused on his high-spending ways. Bianco has just turned 60 and whether he or his board decided it was time for him to leave isn't certain, and really doesn't matter except as fodder for cocktail conversation for those who knew of him, or knew him. Among the latter there's a conviction, summed up by one mutual friend: "He'll be doing something interesting within a year and his interests are so broad, it won't necessarily be in medicine." Bianco's challenges in seeking to find new cancer-fighting innovations and his confrontations with regulators over those drug-focused efforts were well documented over time by local media and wrapped up in a Seattle Times article following his sudden departure on October 2. The headline over The Times' story, "CEO Bianco retires after 25 years running profitless CTI Biopharma," was, for those aware of the long adversarial relationship that existed between him and the media, an amusing final putdown. But the person behind the controversies is always more intriguing to me. So it has been with Bianco, with whom I visited frequently over the years, usually while planning for columns exploring various aspects of Bianco and his involvements, including but beyond his company's business performance. Bianco, who received his B.S. in biology and physics from New York University and his M.D. from Mount Sinai School of Medicine, was high visibility in his business and also highly visible in fund-raising efforts for his special causes, though not in a way to designed to attract personal credit. Those personal causes included the Hope Heart Institute, where he and his wife, Sue, won the Wings of Hope award in 2002 and where he's helped revamp the key fund-raising event, and Gilda's Club, the cancer-support organization whose continued existence was largely due to Bianco's personal support. In addition he was long closely involved in the annual Celebrity Waiter event during the years that the Leukemia Society was the beneficiary of the most successful event of its kind in the country. He was long involved with Gilda's Club, named for the late comedian Gilda Radner, and when I once asked him about that involvement, he explained "Gilda's provides that other kind of Medicine, the kind you can't get in hospitals or clinics but that place where family, kids, friends etc have support. It's a great cause, but because they don't do research they're not sexy so funding in these times is tough. That's why I stay involved. It's in our (CTI's) DNA." Bianco's struggles with media coverage, usually over some aspect of the fact that CTI raised and went through about $1.8 billion without turning a profit in its quest for a successful cancer drug undoubtedly played a role in the wild ride investors went on. The stock price peaked in the mid $80s but spent most of the past decade bouncing between a few dollars a share and a few dimes. As one Bianco supporter put it, "let's just say the media and Jim Bianco don't like each other very much," the tension possibly due in part to the fact Bianco enjoys the perks go with the CEO role and is a competitive kind of guy who doesn't shrink from a fight. The latter isn't surprising given his Bronx upbringing as a second-generation Italian kid in a household shared by up to 20 relatives at a time in an environment where "you were okay as long as you didn't leave the few square blocks of our neighborhood." Then he smiled as he recalled that his bus to high school made its closest stop 10 blocks from his home. "Every day I sprinted to the bus because if you couldn't get there faster than anyone else, you were a statistic." He admits he didn't do very well academically in high school, but by the time he found himself at NYU, he recalls that a major disappointment was the lone "B" he received among his "A's." Bianco had a love of the arts from a young age, an involvement that actually brought him into life-saving contact with his most famous patient and ultimately one of his closest friends. As I wrote in a column a few years ago, the first meeting between Jose Carreras and the young physician who would have a key role in the life-saving treatment for his rare form of leukemia turned out to be a bonding moment for the opera singer and a fan "blown away" at being his doctor. "I was a fellow at The Hutch working with Doctor Thomas when they told me a singer from West Side Story, the opera, was coming in for a transplant and since I was from New York, they thought I might know him," recalled Bianco. "Since I had been a season ticket holder at the Met, I immediately identified him and was blown away that I was going to have the privilege of being his doc," said Bianco. "When he met me he observed 'you're not from here, you dress different!' When I told him I saw him at the Met and I loved his performance of Carmen, we hit it off." That first meeting almost 30 years ago was likely on the minds of both Bianco and Carreras when the famed creator of "The Three Tenors" came to Seattle for a special event at Benaroya Hall. The event, billed as "A celebration of life and friendship," was to celebrate both the 25th anniversary of Carrera's victory over cancer and the 90th birthday of Dottie Thomas, wife of the Nobel-prize-winning doctor. The "private performance" recital for about 500 invitees who paid $250 each to support a research fellowship benefiting the Jose Carreras Research Institute and The Hutch, was sponsored by Bianco's company. "When I learned Dottie was turning 90, coupled with the fact that September, 1987, was the month I admitted Jose to the Hutch for his transplant, there was no better tribute to both of these milestones than to bring Jose back to the U.S. for a celebration," Bianco said.
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Jose Carreras to celebrate anniversary of leukemia victory and a special birthday

The first meeting between Jose Carreras and the young physician who would have a key role in the life-saving treatment for his rare form of leukemia turned out to be a bonding moment for the opera singer and a fan "blown away" at being his doctor.

 

"I was a fellow at The Hutch (Fred Hutchinson Cancer Research Center in Seattle), working with Dr. (Donnall) Thomas when they told me a singer from West Side Story, the opera, was coming in for a transplant and since I was from New York, they thought I might know him," recalls Dr. James Bianco.

 

"Since I had been a season ticket holder at the Met, I immediately identified him and was blown away that I was going to have the privilege of being his doc," said Bianco, now CEO of Cell Therapeutics (CTI). "When he met me he observed 'you're not from here, you dress different!' When I told him I saw him at the Met and I loved his performance of Carmen, we hit it off."

 

That first meeting a quarter century ago may well be on the minds of both Bianco and Carreras when the famed creator of "The Three Tenors" will be on hand in Seattle next Tuesday for a special event at Benaroya Hall.

 

The event, billed as "A celebration of life and friendship," will celebrate both the 25th anniversary of Carrera's victory over cancer and the 90th birthday of Dottie Thomas, wife of the Nobel-prize-winning doctor who pioneered the leukemia treatment that saved him.

 

The "private performance" recital for about 500 invitees who will pay $250 each to support a research fellowship benefiting the Jose Carreras Research Institute and The Hutch is being sponsored by Bianco's company, which is focused on development of new cancer-fighting therapies.

 

"When I learned Dottie was turning 90 on September 18th, coupled with the fact that September, 1987, was the month I admitted Jose to the Hutch for his transplant, there was no better tribute to both of these milestones than to bring Jose back to the U.S. for a celebration," Bianco said.

 

Bianco was a young associate at The Hutch who had been recruited by Thomas to come to Seattle from New York City as Thomas assembled a team to assist with his new bone marrow transplantation process that would win him a Nobel Prize in 1990.

 

I asked Bianco, who was the "fellow" in charge of Carreras' medical care, day and night, under an attending physician who provided supervisory oversight, to share some details of Carreras' treatment.

 

He recalled that the singer was assigned to an "an experimental treatment protocol" in which he would have to have his own bone marrow treated to remove leukemia cells because there was no match with the marrow of his siblings.

 

"His leukemia was usually uniformly fatal in adults," Bianco noted. "He would receive the highest amount of total body irradiation and chemo that the center ever utilized."

 

Bianco explained that there was concern over whether Carerras' body would be so damaged by the extreme radiation that his stored bone marrow wouldn't be able to regrow and make normal blood cells. So because of that concern, as well as that the high radiation levels would be potentially fatal to his lungs, liver and GI tract, he was put in an ultra-clean bubble environment.

 

Carreras spent approximately 60 days in that isolation environment from start of transplant until his bone marrow recovered normal blood cell-making ability and was infection free.

 

"That day for Jose was on December 23rd 1987," Bianco said. "I remember because that day I didn't gown up but rather just walked into his isolation room and he freaked out that I wasn't 'clean'"

 

"I opened the barrier to the room and told him he was well enough to go out to his apartment with his family," Bianco recalled. "It was a really memorable and special moment for me and for him. That was a really special Christmas."

 

It was three years later that Carreras went on to world fame when he convinced fellow Spanish tenor Placido Domingo and Italian singer Luciano Pavarotti to perform as "The Three Tenors," with the first event at the Roman Colosseum. The performance resulted in the best-selling classical CD in history, some 16 million copies. Mass concerts by the three continued for more than a decade.

 

After he was discharged to return home from Seattle, Carreras established the Jose Carreras Leukemia Research Foundation and invited Bianco to be a board member.

 

"I have participated on the board ever since," Bianco said. And as part of their continuing friendship, when CTI had its 20th anniversary last year, Carerras did a video tribute to the company's research and efforts to improve cancer treatment.

 

Donnall Thomas is now frail and "not doing well," according to Bianco, who describes his mentor as "inspiring, a pioneer, sweet, honest, compassionate visionary who touched the lives of everyone he trained and treated worldwide."

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Recent success for often-maligned CTI and its CEO stir global interest

Cell Therapeutics Inc., the Seattle biotech firm that has alternately raised and dashed investor hopes over the past 20 years, has scored a triple play in recent weeks, gaining European approval for a new drug, buying a phase-three cancer drug at deep discount and finding a major new investor.

 

The spate of recent news, while drawing little attention from Seattle area media, has left influential national bloggers and websites musing over why CTI's developments haven't attracted more investor interest and movement in its stock price. The stock has stayed under $1 for some weeks and is down 40 percent from a year ago.

 

Attention for CTI has peaked following late May word that the company's cancer drug Pixantrone, with the brand name Pixuvri, has received conditional marketing approval from the European Commission, following February approval from the European Medicines Agency.

 

 
 

National websites have enthused about CTI's recent successes, with the influential market blog "Seeking Alpha" a few days ago offering the intriguing headline, both promising and pointed: "Cell Therapeutics' Pixantrone - Is Hope Coming For Patients And Patient Shareholders?"

 

And the respected "24/7 Wall St. Wire" asked, in a column noting the recent successes, "Can a European Approval of Pixantrone Save Cell Therapeutics?"

 

The Pixantrone approval will allow CTI to produce revenue from the drug in a market about equal in size to the U.S. market, and will also mean that it can accumulate additional data toward FDA approval from the use of Pixantrone in patients with a rare form of non-Hodgkin lymphoma.

 

Just this week, CTI announced that it has completed the acquisition, first announced in April, of Pacritinib, a Phase III-ready drug that's part of a new class of targeting agents, known as JAK inhibitors, for treating myelofibrosis, a type of leukemia that affects bone marrow.

 

The Pacritinib purchase price of $15 million in cash and another $15 million in convertible stock was described by one national blogger as "a near steal" because, despite four competitors, CTI will be going after a piece of what the company views as a $7 billion market in the U.S. alone.

 

Finally, CTI announced a $40 million investment from New York-based Socius Capital, which analysts suggest paid about 10 percent above the CTI stock price for its passive-investment stake of just under 10 percent. That reflected, according to an analyst, "a high level of confidence" in the commercialization of Pixuvri and clinical development of Pacritinib.

 

But it's the Pixantrone success, enhancing the Pacritinib acquisition and spurring the cash infusion, that is most intriguing, particularly, since there are several sub-plots that come into play with the European announcement. Those include the politics surrounding FDA's handling of the pipeline for new potentially life-saving drugs, as well as the emerging controversy over high-priced drugs that offer only a few months of life expectancy for patients.

 

Then there's the on-going dynamic tension between CTI CEO  Dr.James Bianco and Seattle-area media, which have frequently targeted the company and Bianco for the $1.74 billion he's raised and spent without much benefit to shareholders and the wide swings in the stock price over the years, as high as $72 and as low as 88-cents. Bianco's defenders brush aside media criticisms, contending that the only reason CTI is still alive after 20 years is because of Bianco's creativity and leadership.

 

As one Bianco supporter put it, "let's just say the media and Jim Bianco don't like each other very much," the tension possibly due in part to the fact Bianco enjoys the perks that go with the CEO role and is a competitive kind of guy who doesn't shrink from a fight.

 

The latter isn't surprising given his Bronx upbringing as a second-generation Italian kid in a household shared by up to 20 relatives at a time in an environment where

"you were okay as long as you didn't leave the few square blocks of our neighborhood."

 

Then he smiled as he remembered that his bus to high school made its closest stop 10 blocks from his home. "Every day I sprinted to the bus because if you couldn't get there faster than anyone else, you were a statistic."

 

He admits he didn't do very well academically in high school, but by the time he found himself at NYU, he recalls that a major disappointment was the lone "B" he received among his "A's."

 

Medical school, internship and residency in New York led to Seattle and an opportunity at the Fred Hutchinson Cancer Institute, and eventually to the founding of CTI.

 

In addition to being high visibility in his business, he's also highly visible in fund-raising efforts for his special causes, including the Hope Heart Institute, where he and his wife, Sue, won the Wings of Hope award in 2002 and where he's helped revamp the key fund-raising event, and Gilda's Club, for whom he is planning the first capital campaign.

 

He's been involved with Gilda's Club for a dozen years, explaining that it "provides that other kind of Medicine, the kind you can't get in hospitals or clinics but that place where family, kids, friends etc have support. It's a great cause, but because they don't do research they're not sexy so funding in these times is tough. That's why I stay involved. It's in our (CTI's) DNA."

 

The manner in which the European Medicine agency's approach brought conditional approval for Pixontrone while the FDA dallied, eventually causing CTI to withdraw its application, represents another log on the fire of controversy that swirls around getting new drugs through the FDA to patients.

 

In Europe, 25 member states and five independent experts represent the review panel for an application and two-third of the 32 must give their okay. Critics of the FDA process of an office with a single final decision maker in each therapeutic category, from oncology to cardiovascular and rheumatologic, etc. call the European approach a more balanced review.

 

The critics contend that people are losing their lives while the FDA is holding things up and urge that Congress and the administration press for conditional approval as a more certain part of the FDA review process. For obvious political reasons, Bianco declines to join those criticisms, particularly since a new application to the FDA for Pixontrone is planned in a few months.

 

And since Pixontrone will cost, once the pricing is worked out with each of the European countries, somewhere between $33,000 and $38,000 to extend the lives of the target patients by less than a year, it will come to be part of the growing debate over end-of-life costs vs. benefit.

 

But over the longer term, it will be interesting to see how the developments of the past few weeks play out for Bianco and CTI, and to what extent the prediction of one of the national bloggers proves accurate: "It has been a long road for investors of CTIC, but it now looks as though the future is bright."

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