Monthly Archives: April 2002

Smokings Economic losses Put at $7.00 a Pack

  • 4/15/2002
  • Atlanta
  • AP

Each pack of cigarettes sold in the United States costs the nation $7 in medical care and lost productivity, the government said Thursday.

The study by the Centers for Disease Control and Prevention in Atlanta put the nation’s total cost of smoking at $3,391 a year for every smoker, or #157.7 billion. Health experts had previously estimated $96 billion.

Americans buy about 22 billion packs of cigarettes annually. The CDC study is the first to establish a per-pack cost to the nation. The agency estimated the nation’s smoking-related medical costs at $3.45 per pack, and said job productivity lost because of premature death from smoking amounted to $3.73 per pack, for a total of $7.18.

“There’s a big difference in the cost to society and what society is getting back in tax,” said the CDC’s Dr. Terry Pechacek. “We believe society is bearing a burden for the individual behavioral choices of the smokers.” The CDC said is analyzed expenses, both personal and for the health-care industry, and used national medical surveys to calculate the costs to the nation. The agency also reported that smoking results in about 440,000 deaths a year in the United States, up from the government’s previous figure of 430,000, established in the early 1990’s. The new study was conducted from 1995 to 1999.

A spokesman for tobacco giant Brown & Williamson objected that the study presents the figures in a vacuum, without comparing smoking to the financial burdens other people-nonsmokers with diabetes, for example-place on society. “What does that number mean?” spokesman Mark Smith said. “It doesn’t mean anything. It’s bordering on meaningless.” Representatives from the nation’s two other leading tobacco companies-Philip Morris and R.J. Reynolds-did not immediately return calls for comment.

April, 2002|Archive|

High-Dose of INTROGENS ADVEXIN gene therapy provides significant survival advantage to head and neck cancer patients in phase 2 study

  • 4/9/2002
  • San Francisco
  • American Association for Cancer Research

Recurrent head and neck cancer patients receiving higher dose of ADVEXIN® gene therapy in one study had a significant survival advantage when compared to a group of patients in another study receiving a lower dose of the drug, according to the results of two Phase 2 studies presented today at the annual meeting of the American Association for Cancer Research.

Study results show that, for the first five months of the trial, patients in the ADVEXIN high-dose study were 50 percent more likely to live than those in the low-dose study. ADVEXIN, which combines a proprietary adenoviral vector with the p53 gene, is the lead product candidate of Introgen Therapeutics, Inc. (NASDAQ: INGN).

“We are extremely encouraged by these results demonstrating a significant survival advantage in patients who received a high dose of ADVEXIN,” said Max W. Talbott, Ph.D., Introgen’s senior vice president of worldwide commercial development. “There have been drugs approved to treat cancer that demonstrated a less beneficial survival advantage in clinical trials.”

Patients receiving high-dose ADVEXIN had a median survival advantage 2.4 months longer (189 days vs. 114 days) than those receiving a low-dose treatment with the drug. Dosing in the low-dose study was 50 times lower than dosing in the high-dose trial. Dosing in the high-dose trial was consistent with dosing in Introgen’s current phase 3 studies of ADVEXIN in the treatment of head and neck cancer.

Data from the same studies also show a 60 percent improvement in the cancer cell death rate and an 88 percent improvement in median survival among patients in the high-dose trial.

All patients in both studies were treated with intratumoral injections of ADVEXIN alone. The two studies at 34 centers worldwide treated a total of 166 patients with recurrent head and neck cancer who were ineligible for surgery because of the severity of their cancer. A median number of two treatment cycles was received in each study. The most frequently reported side effects were fever/chills and injection site pain/hemorrhage with a higher proportion of fever and chills in the higher dose range. There were no blood, kidney, or liver toxicities observed in patients in either study.

“These findings suggest a potential role for the use of this novel gene-based therapy in the treatment of patients with head and neck cancer and justify ongoing phase 3 trials,” said John Nemunaitis, M.D., associate director of clinical research at U.S. Oncology and principal investigator of the studies. “The large size of these Phase 2 studies and the fact that ADVEXIN was used as a single agent give weight to these data.”

Introgen is currently enrolling head and neck cancer patients in two ongoing pivotal phase 3 trials at 60 centers worldwide as part of the registration program for ADVEXIN. The two randomized, controlled trials, which will involve more than 500 patients, are ongoing. The primary endpoint in one trial is disease progression and the primary endpoint in the other is overall survival. More information about Introgen’s clinical trials can be obtained by e-mailing Introgen at clinicaltrials@introgen.com or by calling the company toll-free at 1-866-631-4646.

ADVEXIN, formerly designated by Introgen as INGN 201, is a patented cancer therapeutic incorporating the p53 tumor suppressor gene in an adenoviral delivery system. ADVEXIN is designed to use the p53 gene to kill cancer cells and to stop tumor growth, without harming normal cells, in cancer patients with both normal and damaged p53 genes. The p53 gene interferes with cancer cells because it is a tumor suppressor gene and carries instructions to make a protein that reacts with the damaged DNA of a cancer cell. Specifically, the p53 protein activates one of two pathways in these cells, to either stop growth by “hibernating” the cell or induce death via a process of programmed cell death, called apoptosis. Both processes provide an important brake to the development of certain cancers.

April, 2002|Archive|

Cancer-killing virus shows promising results in study

  • 4/8/2002
  • Washington DC
  • Reuters

A genetically engineered virus designed to home in on and kill cancer cells may be safe to test in patients whose cancer has spread, researchers said on Monday.

The latest in a series of experiments using Onyx-015, a cold virus altered so that it infects and kills only cancer cells and leaves healthy cells alone, produced positive results on liver cancer, the researchers said. Richmond, California-based Onyx Pharmaceuticals Inc. has been testing the virus for several years, using a variety of novel approaches such as putting it into a mouthwash to treat oral cancer and injecting it into tumors.

In the latest experiment they infused the virus into the livers of patients whose cancers had spread there. “Rather than injecting it directly into the tumor using a syringe and needle, where it might not get distributed evenly, we injected it into the artery, so that the flow of blood carries it throughout the liver,” Dr. Daniel Sze of Stanford University Medical Center in California, who helped lead the study, said in a telephone interview.

The phase I study was meant only to test the safety of the approach, and Sze told a meeting in Baltimore of the Society of Cardiovascular and Interventional Radiology it seemed safe. They tested 35 patients whose gastrointestinal cancer, mostly colon cancer, had spread into the liver. None could be cured by surgery and chemotherapy had stopped working for them, so they were dying of their cancer. Not only was the treatment safe, Sze told the meeting, but it seemed to help fight the tumors. Such patients usually live only six to eight months but the median survival time of this group was just over a year. CT scans showed the livers swelled at first, perhaps a sign of inflammation from the treatment.

TUMORS SHRANK AFTER TREATMENT

“The tumors shrank somewhat, but more impressive was that blood tests showed that abnormal proteins being secreted by the tumors either decreased significantly, or became completely undetectable,” Sze said. “That suggests the tumors, although still visible on the CT scan, are dying or dead.”

The researchers were also scheduled to report on their findings to a meeting in San Francisco of the American Association for Cancer Research. Colon cancer kills 50,000 people every year in the United States, making it one of the deadliest cancers after lung, breast and prostate cancer. It often spreads to the liver, and is very difficult to treat at that stage.

Sze said Onyx-015 might offer an effective way to treat the cancer without the side-effects of chemotherapy. “Standard chemotherapy kills some healthy cells along with the cancer. This engineered adenovirus is designed to kill only the cancer and not to harm healthy cells,” he said. The adenovirus his team used is a relative of the common cold virus. When it attacks cells it uses a protein called p53, which happens to help repair the kind of damage that leads to cancer.

About 60 percent of cancer cells have mutated p53 genes. Researchers changed the adenovirus so that it could not make use of p53 and therefore should not be able to invade healthy cells, but could attack cancer cells with faulty p53. Sze said his team realized that infusing a virus into the liver could be dangerous. Such a treatment killed 18-year-old Jesse Gelsinger in 1999 in a gene therapy experiment. Sze said the cancer experiment took this into account. “The maximum dose (used in the Gelsinger case) was something like 25 times as high as our maximum dose,” he said.

“That is the Jesse Gelsinger legacy — you can’t indiscriminately keep going up. Also, even though our patients had tumors, their liver function was normal. We were certainly aware that if we gave too much stress on the livers they could go into liver failure.”

April, 2002|Archive|