Results of the company’s late-stage trial of the drug showed that Onconase did not achieve significantly higher survival rates among patients with unresectable malignant mesothelioma when given in combination with doxorubicin, another cancer chemotherapy drug.

According to a report on Pharmaceutical Online, the preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving Onconase plus doxorubicin. The median survival time (MST) for evaluable patients who received Onconase plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

However, there is a silver lining to the study. Pharmaceutical Online reports those patients who failed a previous chemotherapy regimen who received Onconase plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin, which is considered a statistically significant result.

Reuters reports as a result of this secondary finding, Alfacell will now submit a marketing application to the Food and Drug Administration for use of the drug on those patients, with hopes to have it approved by the end of the year.

SOURCE: myMeso › Onconase fails in primary late-stage trial

The article starts from the viewpoint of economics, exploring the rising costs of asbestos insurance claims, but goes on to talk with several people who were featured speakers at the recent Asbestos Awareness Day Conference, held in Detroit, touching on the human issue and the projected cost in human life.

There is some valuable statistical information in this article.

Take a look – it’s worth reading!

It’s a real shame that the issue of asbestos awareness doesn’t seem to be getting much attention in the media outside of Michigan, where the conference was held. I’d like to see some national news outlets pick up on this!

SOURCE: myMeso › Excellent story on asbestos cost, impact

In accordance with the statistical plan for the trial, the company has begun the process necessary to conduct the formal statistical analyses required to complete the final sections of the ONCONASE rolling New Drug Application (NDA).

The trial was designed to show a statistically significant improvement in overall survival for UMM patients who were treated with a combination of ONCONASE and doxorubicin as compared to UMM patients who were treated with doxorubicin as a single agent. Enrollment in the ONCONASE Phase IIIb clinical trial closed on Sept. 30, 2007. A total of 428 patients were enrolled in the trial.

Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa, the branded product division of Par Pharmaceuticals, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.

ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the U.S. Food and Drug Administration (FDA). Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.

SOURCE: myMeso › ONCONASE on fast track for Meso treatment

The article, published in the March issue of Cancer Cell, says the mouse model will help provide insight into the development and progression of MM, as well as indicate new directions for therapeutic strategies. This, Genova reports, “may eventually lead to a substantially improved outlook for patients with this devastating disease.”

Due to the aggressive nature of mesothelioma, and its low survival chances, doctors agree that there is an urgent need for experimental models for its study, she said.

Genova quotes Dr. Anton Berns, from the Netherlands Cancer Institute, whose team discovered the mouse model. “Our mouse models should be suitable to further dissect pathways critically important in mesothelioma development and progression and serve as invaluable tools to test new intervention strategies,” he said.

The full article is available here, at EurekAlert! or visit Cell Press online.

SOURCE: myMeso › Thanks, Mickey!

Treating Mesothelioma

Because this is such a rare cancer, it has been hard for doctors to compare the value of different treatments. Since many doctors have little or no experience treating this disease, you may be referred to a specialist at a large medical center.Treatment options include surgery, chemotherapy and radiation therapy.One problem with treating mesothelioma is that it does not grow as a single mass. Instead it tends to spread along surfaces, nerves, and blood vessels. This makes it hard for one or more types of treatment to get rid of all of the disease.While surgery is not likely to cure the cancer, it might extend the patient’s life.Depending on the type and stage of the cancer, chemotherapy may be given as the main treatment or along with surgery. Chemotherapy for this disease is given to relieve symptoms, not to cure the cancer.As a rule, radiation treatment doesn’t help much for mesothelioma, and the need to treat a large part of the lung leads to problems with lung damage. But radiation can be used along with surgery to kill small areas of cancer that cannot be seen and removed during surgery. It can also be used as a way to ease symptoms such as shortness of breath, pain, bleeding, or trouble with swallowing. If fluid builds up in the chest, radioactive drugs can be put into the space after the fluid is drawn out. This might help keep the fluid from coming back.

New in Mesothelioma Research

There is always research going on in the area of mesothelioma. Much of this research has focused on learning exactly how asbestos changes normal cells and their DNA to cause cancer. Understanding how these fibers produce cancer might help us find ways to prevent those changes.Now that we know about the dangers of asbestos, we can limit or stop its use in homes, public buildings, and the workplace. But rules to protect people from asbestos are much less strict (or they do not exist at all) in some other countries.Research is also going on to learn about the role (if any) of a virus (SV40) that has been linked to mesothelioma in some studies.Because chemotherapy drugs have not worked very well against advanced mesothelioma, several new ideas are now being studied. These include drugs which kill cancers by stopping their blood supply and drugs which interfere with the ability of some cancer cells to grow quickly.Doctors are always learning more about the best way to treat people with mesothelioma. Treatments that combine surgery, radiation therapy, and chemotherapy are now being studied and may provide the most promising option for some patients.New drugs, along with other types of treatments, are now being tested in clinical trials.Another new approach is a type of gene therapy. This treatment uses special viruses that have been changed in the lab. The virus is injected into the space around the lungs where it infects the cancer cells. When this happens, the virus in turn injects a gene into the cancer that may help immune system cells to attack the cancer.

Research at UAB

The University of Alabama Birmingham (UAB) Comprehensive Cancer Center is a research and teaching hospital, and is currently conducting a number of studies on the treatment of mesothelioma.In 2005, UABs Spring/Summer magazine published information about ongoing studies being conducted by Katri Selander, M.D., Ph.D., a Cancer Center Associate Scientist, and Pierre Triozzi, M.D., about the effects of bisphosphonates on cancer cells.Bisphosphonates are drugs that are commonly used to treat and prevent osteoporosis. They also are used to treat metastatic breast and prostate cancers.The UAB article reported that Drs. Selander and Triozzi “have examined the effects of bisphosphonates on cancer cell cultures and in animal models, and have found that the drugs kill mesothelioma cells in both.” Further results of these studies were reported in the May 1, 2006 issue of Clinical Cancer Research, Vol. 12, 2862-2868; and in the European Journal of Pharmacology, Volume 559, Issue 1, dated March 15, 2007. Key points of the article in Clinical Cancer Research said that “the diagnositc use of radioactive bisphosphonates has revealed the accumlation of bisphosphonates in mesothelioma” and said that results of the studies “support further study of bisphosphonates in the management of mesothelioma.” The European Journal of Pharmacology report states that “Pre-clinical studies indicate that bisphosphonates also ihibit the growth of various cancer cells in vitro” and “in … mouse AB-12 mesothelioma cells.” For more information, visit UAB’s Comprehensive Cancer Center.

SOURCE: myMeso › Mesothelioma Treatment Options

There are links on this page to a number of web sites that provide medical information and information about asbestos, exposure to which is the leading cause of Mesothelioma. Check back regularly, as I will be adding to that list of links in addition to posting new information here.

Here is a good general definition, from the University of Alabama Birmingham (UAB) Medical Center, which has a Mesothelioma Clinic at its Comprehensive Cancer Center :

Q: What is mesothelioma and who is at risk?

A: Mesothelioma is an aggressive form of cancer in which cells of the mesothelium (the membrane that covers and protects most of the internal organs) become abnormal, form tumors, and grow without control or order. The disease usually affects the surface of the lung or less commonly the lining of the abdomen. It is relatively uncommon, with 2,500-3,000 new cases diagnosed in the United States each year. The major risk factor is working with asbestos, but the disease has been reported in some individuals without any known exposure to it. An experimental drug, Pemetrexed®, has shown promise in treating advanced mesothelioma. The UAB Mesothelioma Clinic and Comprehensive Cancer Center offer clinical trials for treating the disease. Early referral for the best treatment is important after diagnosis.

UAB is a research and teaching hospital, and is currently conducting a number of studies on the treatment of mesothelioma.

In 2005, UAB’s Spring/Summer magazine published information about ongoing studies being conducted by Katri Selander, M.D., Ph.D., a Cancer Center Associate Scientist, and Pierre Triozzi, M.D., about the effects of bisphosphonates on cancer cells.

Bisphosphonates are drugs that are commonly used to treat and prevent osteoporosis. They also are used to treat metastatic breast and prostate cancers.

The UAB article reported that Drs. Selander and Triozzi “have examined the effects of bisphosphonates on cancer cell cultures and in animal models, and have found that the drugs kill mesothelioma cells in both.”

Further results of these studies were reported in the May 1, 2006 issue of Clinical Cancer Research, Vol. 12, 2862-2868; and in the European Journal of Pharmacology, Volume 559, Issue 1, dated March 15, 2007.

Key points of the article in Clinical Cancer Research said that “the diagnositc use of radioactive bisphosphonates has revealed the accumlation of bisphosphonates in mesothelioma” and said that results of the studies “support further study of bisphosphonates in the management of mesothelioma.”

The European Journal of Pharmacology report states that “Pre-clinical studies indicate that bisphosphonates also ihibit the growth of various cancer cells in vitro” and “in … mouse AB-12 mesothelioma cells.”

For more information, visit UAB’s Comprehensive Cancer Center online at www3.ccc.uab.edu or click on the link in my list.

SOURCE: myMeso › Mesothelioma Research