Posts Tagged ‘UAB’

Onconase fails in primary late-stage trial

30 May 2008 by under News, Research/Treatment

Alfacell Corp., a biotechnology company that manufactures Onconase, released a disappointing report Wednesday regaring its Onconase product, which was hoped to be a significant treatment for mesothelioma. The drug already has orphan-drug status for the treatment of malignant mesothelioma in the U.S., Europe and .

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.


Excellent story on asbestos cost, impact

3 Apr 2008 by under News

The Ann Arbor Business Review has an excellent article today about the costs – both financial and the cost in human lives – of asbestos disease.

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 , 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!


ONCONASE on fast track for Meso treatment

2 Apr 2008 by under News, Research/Treatment

SOMERSET, N.J., April 2, 2008 – PRNewswire – Alfacell Corporation today announced that it has confirmed that 316 evaluable events (patient deaths) have occured in the confirmatory Phase IIIb clinical trial of its lead compound, (ranpirnase), for the treatment of patients with unresectable malignant mesothelioma (UMM).

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.


Thanks, Mickey!

11 Mar 2008 by under Organizations, People, Research/Treatment

An article released yesterday, March 10, by Cathleen Genova at Cell Press, reveals that scientists have established a for human malignant mesothelioma (MM).

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.


Mesothelioma Treatment Options

27 Feb 2008 by under

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Mesothelioma Research

14 Feb 2008 by under Organizations, People, Research/Treatment

If you are reading this blog, chances are good that you are already familiar with Mesothelioma, and may actually have been diagnosed with this cancer yourself. But part of the mission of this blog is to raise awareness, so let me start by offering some general information and some resources.

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 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 , 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.