ILXO,MLNM
ILXO might benefit more than MLNM from the new drug approval.According to DJ news this new drug will signal ILXO's "arrival" as a Biotech.ILXO is having a conference call at 3 PM Eastern.
FDA Panel Okays Ilex, Millennium's Campath For Leukemia
Dow Jones Newswires
By Otesa Middleton
WASHINGTON -- Patients with a rare leukemia soon may have another treatment option after a federal panel Thursday recommended government approval of a new drug from Ilex Oncology Inc. (ILXO) and Millennium Pharmaceuticals Inc. (MLNM)
For patients with chronic lyphocytic leukemia, there is no drug approved for use after the first and second line treatments of alkylating drugs and fludarabine therapy.
Ilex and Millennium want their product, Campath, approved as a third resort for these very sick patients.
With the panel's support, the Food and Drug Administration will probably grant the biotech companies' request, although the agency isn't required to follow the group's advice.
In the main study of Campath, all 93 patients enrolled were treated with the intravenous drug. No inactive placebo was used for comparison because it is considered unethical to give patients with a life-threatening disease a dummy treatment when approved medicines exist.
Slightly more than 33% of patients responded to the treatment, meaning they experienced at least a 50% reduction in the amount of tumors or disease found in their bodies. To be considered a response, the reduction must last at least two months.
Once treated, the median survival time for patients was 16 months.
While involved in the trial, 15 patients died and 44 dropped out because of severe side effects. Seven patients died from infections, five because their disease progressed and one each died from suicide, cerebral hemorrhage and blood clot in the lungs.
WASHINGTON -- A federal panel dealt Maxim Pharmaceuticals Inc. (MAXM) a crushing blow Wednesday when it recommended against approval of what the company hopes will be its first drug, Maximine.
Without the panel's endorsement, Maxim's application before the Food and Drug Administration will likely be rejected. The FDA isn't required to turn down drugs on advice of its panels, but the agency usually does.
The company's stock price has suffered a 56% loss over the last two trading sessions as investors anticipated a negative panel review.
Maxim wants Maximine approved for treating the deadliest form of skin cancer - malignant melanoma in which the cancer has spread to the liver. Many patients with the disease at this stage live less than one year.
Sending a clear message to the FDA, the panel unanimously voted against recommending FDA approval for Maximine, because, the panel said, Maxim's data wasn't convincing.
Dr. Judy Chiao, the FDA's medical reviewer, told the panel the agency found discrepancies in the data Maxim submitted on Maximine.
"There was lack of internal consistency," Chiao said. "We don't have complete information."
Maxim studied 305 malignant melanoma patients. The study included patients whose disease had spread to the liver and some who didn't have the disease in the liver.
Maxim's study looked at Maximine, a histamine injection, used in combination with interleukin-2 and compared that regimen with interleukin-2 alone.
Maxim's data didn't show a benefit for using Maximine when all the patients in the study were examined. However, the company said Maximine did perform better than interleukin-2 alone in those patients with disease in the liver.
The problem with this analysis, Chiao said, was Maxim's decision to pull out and analyze that subgroup of patients after the trial was completed, instead of at the beginning. This hurt the trial's credibility, the panel said.
Also, she said with only one trial presented and many of the study patients dropping out of the trial because their disease spread, the evidence supporting Maximine wasn't convincing.
Dr. Rajeshwari Sridhara, FDA's statistical reviewer, told the panel that "because of imbalances, it is appropriate to further evaluate" Maximine.
Panelist Dr. George W. Sledge Jr., medical professor at Indiana University School of Medicine, said he was concerned because several patients were enrolled in the study that didn't meet the criteria outlined before the trial began.
"There is an astoundingly high number of enrollment violations," Sledge said.
With so many violations in enrolling patients, Sledge said, he doesn't know what other violations were present in the way the study was conducted.
Panelist Richard M. Simon, chief of the National Cancer Institute's biometric research branch, said evaluating a drug based on one study isn't preferred especially based on a subset of patients who weren't the primary focus of the study.
"I hope a second trial can be done," Simon said. "I'm very puzzled by this data."
Panelist Bruce G. Redman, associate medical professor at the University of Michigan Comprehensive Cancer Center, said when a drug is approved based on a its effectiveness in helping patients that have had the cancer spread to a single site "you need an excellently controlled trial."
"I don't think this trial met that criteria," Redman said.
Steve Brozak, who follows biotechnology companies for Vanguard Capital, said the panel rejection is a severe setback for the company.
"This is not terribly good for the company," Brozak said. "This means the company has to go out and start from close to scratch."
To bounce back, Brozak said Maxim can sit down with the FDA to find out what additional tests it needs to conduct, he said. However, overwhelmingly positive data shouldn't be expected because Maximine is targeting an extremely sick population.
"These people have endstage cancer and there is no real efficacious treatment that will prolong life," Brozak said. "The company may have a shot at doing it again. This will effect financing for all biotechs out there |
