Posts Tagged ‘FDA’

COMMAND clinical trial treating patients with malignant pleural mesothelioma

2 Oct 2013 by under Events, News, Research/Treatment

cancer stem cell 100x100 COMMAND clinical trial treating patients with malignant pleural mesotheliomaDrug manufacturer Verastem, Inc., has initiated a registration-directed, double-blind, placebo-controlled clinical trial for patients with malignant . The trial is a registration-directed trial for VS-6063, Verastem’s lead cancer stem cell inhibitor defactinib , and will target killing cancer stem cells. The clinical trial is called Control of Mesothelioma with MAiNtenance Defactinib, or . (more…)


ONCONASE expands to Israel as meso concerns there grow

15 Jul 2008 by under News, Research/Treatment

Today Alfacell, the manufacturer of ONCONASE, announced it will begin distribution of the mesothelioma drug in . The company will partner with Megapharm, Ltd., a leading pharmaceutical company in . ONCONASE recently completed an international confirmatory Phase IIIb clinical trial for unresectable malignant mesothelioma.

The news comes just a day after Haaretz.com, a leading news outlet in Israel, noted that asbestos-related cancer is 10 times more prevalent in Nahariya, a city of approximately 50,000 located in the North District of Israel on the Mediterranean sea, just south of the Lebanese border at Rosh HaNikra, than it is in the rest of the country. The report is based on data submitted by the chief doctor of the Health Ministry’s Acre District.

The medical report was presented to the Knesset Internal Affairs Committee, which is currently calling for greater action from Nahariya’s government to address the problem. The story quotes Tamar Bar On, head of the Environment Ministry’s Asbestos Department, as saying that “between 70 to 150 thousand cubic meters of asbestos [can] be found scattered across the Western Galilee, mainly in private yards.”

Committee MK Yossi Beilin (Meretz) has been selected by the committee to chair a panel dedicated to addressing the asbestos problem in Nahariya.

Alfacell will manufacture and supply ONCONASE to Megapharm, while Megapharm will be responsible for all activities and costs related to regulatory filings and commercial activities in a defined marketing territory, according to an Alfacell press release.

ONCONASE is a first-in-class therapeutic product candidate based on Alfacell’s proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.

ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.


Quintessence continues with mesothelioma drug

5 Jun 2008 by under News, Research/Treatment

On April 21 I reported that a Madison, Wisconsin-based biotechnology firm, Quintessence Bioscience, was moving forward on a drug similar to Alfacel’s Onconase, to treat mesothelioma. The report, from Steve Clark for WTN (Wisconsin Technology Network) News, noted that the company’s QBI-139 is very similar to Onconase, but has not been clinically tested yet.

Of course, on Monday this week, it was announced and reported here that Onconase had failed the primary objective of its late-stage trial. This news was particularly disappointing since the drug already has orphan drug status in the U.S., Europe and due to the very high hopes for its success. Despite failing in its primary objective, however, testing did show that the drug is effective in a secondary effect, helping to prolong the life of those treated after standard chemotherapy has failed.

The report of Onconase’s initial failure prompted WTN’s Clark to revisit Quintessence to find out if the Onconase failure would derail the development of their QBI-139. In his new report, Clarks says he found researchers undaunted and pressing forward. He says they to move the drug into clinical trials sometime this summer, and they believe the success of Onconase’s secondary role and hopeful FDA approval in that area will help pave the way for general acceptance of RNase cancer therapies.

In his earlier report, Clark pointed out that QBI-139 has several differences from Onconase in the way it is produced, which he believes will make it inherently more effective than Onconase.

He points out that mesothelioma is a particularly difficult cancer to treat, and wonders if the selection of mesothelioma as a research track by Alfacell was made to help fast-track the development of the drug. Perhaps, he wonders, the drug might be more effective on “more common and easier to treat cancers than mesothelioma.”


Mesothelioma and chemotherapy research

19 May 2008 by under News, Research/Treatment

This week BBC News / Health reported on a recent study published by The Lancet, which features independent and authoritative commentary on global medicine, including research and analysis from all regions of the world. The study suggests that chemotherapy is not effective in dealing with , which is an asbestos-induced cancer that effects the lungs and, more rarely, the abdomen.

The results are based on a study of 409 patients, mostly from the United Kingdom, which set out to assess the potential benefits of combining active symptom control, which usually involves steroid drugs and radiotherapy, with chemotherapy. Results showed no real benefit from adding the chemotherapy drugs compared with just treating the symptoms of the disease.

The BBC quotes one of the authors of the study, Dr Richard Stephens from the Medical Research Council Clinical Trials Unit, as saying, “While thousands are and will be affected by this deadly disease, our trial, which is one of the few large trials ever conducted in this disease, emphasizes how difficult mesothelioma is to treat. This is mainly because mesothelioma forms in the lining of the lung. This makes it hard to target.”

One chemotherapy drug, vinorelbine, was shown by the study to have some promise, but researchers do not think blanket chemotherapy treatment is a promising direction for treatment of mesothelioma, according to the Lancet report.

Researchers do not necessarily consider these findings to be bad news, as a study that defines what does not help can be beneficial to patient health because it helps reduce the chance that patients will undergo stressful treatments that are ineffective.

Results of a completely different chemotherapy study conducted by researchers at Duke Comprehensive Cancer Center were released May 18, revealing that chemotherapy given in conjunction with cancer vaccines may actually boost the immune system’s response to the vaccines, according to a report by ScienceDaily.

The Duke study focused on a drug used to treat lymphoma, but could have implications for clinical trials with vaccines being used to treat many cancers including lung cancer, brain tumors and colorectal cancer.

According to the FDA, it is the goal of cancer vaccine clinical trials not to prevent cancer, but to treat existing tumors. The idea is to train the person’s immune system to recognize the living cancer cells and attack them.

In July 2007, the American Association for Cancer Research examined the issue of cancer vaccines and, according to a report by Medical News Today, they found that “ongoing therapeutic cancer vaccine trials have yet to show evidence of vaccines spurring a patient’s immune system to shrink tumors – yet patients who receive these vaccines in trials tend to live longer and respond better to subsequent treatment.”

The full study, titled Cancer Vaccines: Moving Beyond Current Paradigms is available to read online at Clinical Cancer Research.

Full results of the Duke study will be presented May 31 at the American Society of Clinical Oncology meeting in Chicago, Ill.


Living with Meso – Charlene’s story UPDATE

6 May 2008 by under People, Research/Treatment

nccam logo 01 150x62 Living with Meso   Charlenes story UPDATEToday I received a wonderful email from Charlene Kaforey. Some of you have followed along with her story about her own fight with mesothelioma, which was published here in March and April. For those that are unfamiliar, Charlene, who just turned 49, was diagnosed with mesothelioma in June 2007.

With a stage III diagnosis, she underwent chemotherapy treatments from October to December of that year, and then, faced with the prospect of a pleurectomy or pneumonectomy, which would remove part or all of the affected lung, decided to try alternative medicine.

Charlene went to the ITL Alternative Cancer Treatment Clinic in Freeport, Grand Bahamas, in January 2008, where she underwent an 8-week treatment called Immuno-Augmentation Therapy (IAT). Upon returning home, she administers her own vaccines several times a day, and has been continuing a twice-daily intravenous vitamin C program with the help of a nurse friend.

She celebrated her birthday Sunday, then on Monday went for her first CT scan since beginning her alternative treatment. Charlene reports, “There was overall improvement in my scan results!! The tumor was half of what it was previously, the pleural thickening was reduced, fluid is reduced and the pleural effusion is gone. I am thrilled, and stunned. Of course, I’m still guardedly optimistic, since I do still have cancer and the results could change at any time. But this, for now, this is the best birthday present I could have gotten!”

Alternative therapies like IAT are not authorized by the American Medical Association, and there is still a lot of skepticism and caution surrounding them. Generally, medical insurance does not cover alternative medical treatments like IAT.

Treatments that are not considered conventional medicine, but that are undertaken along with traditional medical therapies, like chemotherapy, radiation and surgery, are called complementary. Treatments used in place of conventional medicine, like the IAT Charlene is undergoing, are called alternative medicine.

IAT, along with other complementary and alternative medicine (CAM) programs, are being studied by the U.S. Department of Health and Human Services, the Food and Drug Administration (FDA) and the National Center for Complementary and Alternative Medicine (NCCAM), which operates under the Department of Health and Human Services.

Patients considering complementary or alternative treatments are encouraged to thoroughly research possible risks, benefits, and scientific evidence, and to discuss alternatives with their physician.

For more information, visit the NCCAM online, in the “health” section under “be an informed consumer.” They have information on topics including what to do when considering using CAM, how to select a CAM practitioner, and paying for CAM treatment.

I will be exploring CAMs in the coming weeks, and hope to talk to physicians and alternative and complementary treatment doctors and specialists about these programs, as well as patients like Charlene who are using them. If you’ve had an experience with a CAM, leave a comment or email me and share your experience.

I am thrilled for Charlene! Happy Birthday!!


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, ONCONASE (ranpirnase), for the treatment of patients with unresectable malignant (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 .