Post by Deanne Jenkyns on Jan 3, 2009 15:32:48 GMT 1
S.D. company's Lucanix extended lives in early tests; Phase 3 begins By Terri Somers
STAFF WRITER
August 21, 2008
Oncologist Lyudmila Bazhenova has a new weapon in her arsenal to help late-stage lung cancer patients fight for survival: an experimental cancer vaccine called Lucanix, developed in San Diego by privately held NovaRx.
EDUARDO CONTRERAS / Union-Tribune
Jason Fuentes removed the Lucanix cancer vaccine from liquid nitrogen-filled storage containers at NovaRx in San Diego on Tuesday. Lucanix is in Phase 3 clinical trials.
Whether Lucanix will prove itself a worthy combatant against the world's most deadly type of cancer won't be known for several years. It must be tested on up to 700 people in a worldwide Phase 3 clinical trial and treated at 90 sites in the United States, Canada, India and Europe.
But early stage trials show it is extending the lives of patients for years, offering promise to a group of patients whose prognosis has not improved much in more than a decade. The few drugs for lung cancer approved in recent years have extended survival only minimally.
Bazhenova, who works at the Moores Cancer Center at UCSD, injected the first patient in the clinical trial yesterday. The patient, like all those in the trial, has advanced non-small-cell lung cancer.
Lung cancer kills more than 400 people a day in the United States and more than 2,500 worldwide. Only 30 percent of the people with late-stage lung cancer live beyond a year.
As principal investigator of the Phase 3 trial, Bazhenova was enthusiastic about the therapy.
“The way I look at it is that only a certain amount of drugs work for a limited time in this disease. If someone wants to give me an extra bullet, why wouldn't I take it?”
EDUARDO CONTRERAS / Union-Tribune
Lucanix, which might help late-stage lung cancer patients, is shipped in packages like this one.
Traditional chemotherapy drugs kill tumor cells but also kill healthy cells, causing debilitating side effects.
The alternative pathway of Lucanix is the body's immune system, which is induced by the drug to target the cancer cells.
There has been a lot of hope for so-called therapeutic vaccines, or immunotherapies. But none have been successful. The field is littered with failed clinical trials, including those run by local companies Vical, Favrille and the now-defunct or merged CancerVax, Epimmune and Collateral Therapeutics.
Lucanix is different from all those failed vaccines, said Habib Fakhrai, co-founder of NovaRx. None addressed the suppression of the immune system, he said.
The Iranian-born Fakhrai began his work on what would become Lucanix in the early 1990s, first at San Diego's Sidney Kimmel Cancer Center and, later, as director of the gene therapy laboratories at UCLA's medical school. He and fellow researcher Daniel Shawler were trying to develop a gene therapy vaccine for cancer. Fakhrai was nagged by the role that immune suppression played in cancer, accounting for secondary infections such as pneumonia. The scientists thought that if they could boost the immune system, it would benefit their gene therapy drug, said Shawler, now vice president of operations at NovaRx.
But the results were lackluster.
Fakhrai had read research that said cancer cells emitted a substance called TGF-beta which made them invisible to the body's immune system. So Fakhrai found a way to suppress the production of TGF-beta, essentially removing the cancer's cloak of invisibility and calling the body's immune system to attack.
In the first animal model, a mouse with a brain tumor, Fakhrai's discovery cured cancer 100 percent. It was also successful in an early stage human trial.
But brain tumors are rare, so there are few investors looking to develop a therapy. Fakhrai decided to try Lucanix on lung cancer.
He chose non-small-cell lung cancer because it kills more people than the next four highest cancer killers – breast, colon, prostate and pancreas.
“Our results were beyond expectation,” Fakhrai said.
In Phase 2 testing of patients with advanced disease who received Lucanix after minimal chemotherapy, there was a one-year survival rate of 61 percent and two-year survival rate of 41 percent. The median survival time was 16 months. Typically these patients would have a one-year survival rate of less than 30 percent.
In another Phase 2 trial, 59 percent of patients whose disease was stabilized by chemotherapy lived more than 43 months.
Some who have been permitted by the FDA to continue taking the experimental drug are still alive after more than five years, Fakhrai said.
“And we've seen virtually no side effects,” he said.
NovaRx, which was founded in 1997 and now has 50 employees, needed money if it was going to push forward with expensive Phase 3 clinical trials. It had been surviving solely on government grants and private investment.
Eventually, Justin Murdock, senior vice president of investments for Castle & Cooke and the Dole Food Co., heard about the company. At the time, Murdock was expanding investments in the North Carolina Research Campus, a biotech hub.
The Castle & Cooke companies, an umbrella of businesses that include real estate, manufacturing and transportation, have about 63,000 employees working in more than 90 countries.
“We have a lot of core businesses in things that are necessities and we know are solid, so a little bit of risk in the portfolio we felt was a good thing,” Justin Murdock said. “Biotech seemed like a natural progression. It's not a money thing; we're not looking for the big score.”
Murdock was intrigued by the immune suppression factors of Lucanix. In October 2006, he invested in NovaRx, becoming majority owner, as well as chief executive and chairman.
Four months later, federal regulators granted Lucanix fast-track status, given to therapies that could serve an unmet need.
The gold standard for judging a cancer therapy's success is survival, Shawler said. But NovaRx doesn't look at the goal as buying time, he said.
“We hope that the survival is long term. Our goal is to have cancer patients die with the disease, rather than from the disease.”
STAFF WRITER
August 21, 2008
Oncologist Lyudmila Bazhenova has a new weapon in her arsenal to help late-stage lung cancer patients fight for survival: an experimental cancer vaccine called Lucanix, developed in San Diego by privately held NovaRx.
EDUARDO CONTRERAS / Union-Tribune
Jason Fuentes removed the Lucanix cancer vaccine from liquid nitrogen-filled storage containers at NovaRx in San Diego on Tuesday. Lucanix is in Phase 3 clinical trials.
Whether Lucanix will prove itself a worthy combatant against the world's most deadly type of cancer won't be known for several years. It must be tested on up to 700 people in a worldwide Phase 3 clinical trial and treated at 90 sites in the United States, Canada, India and Europe.
But early stage trials show it is extending the lives of patients for years, offering promise to a group of patients whose prognosis has not improved much in more than a decade. The few drugs for lung cancer approved in recent years have extended survival only minimally.
Bazhenova, who works at the Moores Cancer Center at UCSD, injected the first patient in the clinical trial yesterday. The patient, like all those in the trial, has advanced non-small-cell lung cancer.
Lung cancer kills more than 400 people a day in the United States and more than 2,500 worldwide. Only 30 percent of the people with late-stage lung cancer live beyond a year.
As principal investigator of the Phase 3 trial, Bazhenova was enthusiastic about the therapy.
“The way I look at it is that only a certain amount of drugs work for a limited time in this disease. If someone wants to give me an extra bullet, why wouldn't I take it?”
EDUARDO CONTRERAS / Union-Tribune
Lucanix, which might help late-stage lung cancer patients, is shipped in packages like this one.
Traditional chemotherapy drugs kill tumor cells but also kill healthy cells, causing debilitating side effects.
The alternative pathway of Lucanix is the body's immune system, which is induced by the drug to target the cancer cells.
There has been a lot of hope for so-called therapeutic vaccines, or immunotherapies. But none have been successful. The field is littered with failed clinical trials, including those run by local companies Vical, Favrille and the now-defunct or merged CancerVax, Epimmune and Collateral Therapeutics.
Lucanix is different from all those failed vaccines, said Habib Fakhrai, co-founder of NovaRx. None addressed the suppression of the immune system, he said.
The Iranian-born Fakhrai began his work on what would become Lucanix in the early 1990s, first at San Diego's Sidney Kimmel Cancer Center and, later, as director of the gene therapy laboratories at UCLA's medical school. He and fellow researcher Daniel Shawler were trying to develop a gene therapy vaccine for cancer. Fakhrai was nagged by the role that immune suppression played in cancer, accounting for secondary infections such as pneumonia. The scientists thought that if they could boost the immune system, it would benefit their gene therapy drug, said Shawler, now vice president of operations at NovaRx.
But the results were lackluster.
Fakhrai had read research that said cancer cells emitted a substance called TGF-beta which made them invisible to the body's immune system. So Fakhrai found a way to suppress the production of TGF-beta, essentially removing the cancer's cloak of invisibility and calling the body's immune system to attack.
In the first animal model, a mouse with a brain tumor, Fakhrai's discovery cured cancer 100 percent. It was also successful in an early stage human trial.
But brain tumors are rare, so there are few investors looking to develop a therapy. Fakhrai decided to try Lucanix on lung cancer.
He chose non-small-cell lung cancer because it kills more people than the next four highest cancer killers – breast, colon, prostate and pancreas.
“Our results were beyond expectation,” Fakhrai said.
In Phase 2 testing of patients with advanced disease who received Lucanix after minimal chemotherapy, there was a one-year survival rate of 61 percent and two-year survival rate of 41 percent. The median survival time was 16 months. Typically these patients would have a one-year survival rate of less than 30 percent.
In another Phase 2 trial, 59 percent of patients whose disease was stabilized by chemotherapy lived more than 43 months.
Some who have been permitted by the FDA to continue taking the experimental drug are still alive after more than five years, Fakhrai said.
“And we've seen virtually no side effects,” he said.
NovaRx, which was founded in 1997 and now has 50 employees, needed money if it was going to push forward with expensive Phase 3 clinical trials. It had been surviving solely on government grants and private investment.
Eventually, Justin Murdock, senior vice president of investments for Castle & Cooke and the Dole Food Co., heard about the company. At the time, Murdock was expanding investments in the North Carolina Research Campus, a biotech hub.
The Castle & Cooke companies, an umbrella of businesses that include real estate, manufacturing and transportation, have about 63,000 employees working in more than 90 countries.
“We have a lot of core businesses in things that are necessities and we know are solid, so a little bit of risk in the portfolio we felt was a good thing,” Justin Murdock said. “Biotech seemed like a natural progression. It's not a money thing; we're not looking for the big score.”
Murdock was intrigued by the immune suppression factors of Lucanix. In October 2006, he invested in NovaRx, becoming majority owner, as well as chief executive and chairman.
Four months later, federal regulators granted Lucanix fast-track status, given to therapies that could serve an unmet need.
The gold standard for judging a cancer therapy's success is survival, Shawler said. But NovaRx doesn't look at the goal as buying time, he said.
“We hope that the survival is long term. Our goal is to have cancer patients die with the disease, rather than from the disease.”
LC charity Ball