SEPREHVIR(R) (HSV1716), An Oncolytic Virus For Possible Treatment Of Malignant Pleural Mesothelioma: Phase I/IIa Clinical Study Underway As Of August 2013

Virttu Biologics Limited, a UK biotechnology company, issued this press release in late August 2013, “Oncolytic Virus Specialist Virttu Biologics Confirms Treatment of First Cohort of Patients in Phase I/II SEPREHVIR(R) Study in Mesothelioma.”

From that article we get these four (4) facts:

  1. SEPREHVIR (HSV1716) is a variant of Herpes Simplex Virus 1 that has been engineered to kill cancer cells while leaving normal cells unharmed.
  2. Malignant pleural mesothelioma (MPM) has a long latency (30-60 years from occupational exposure) and Virttu estimates that around 9500 new cases of MPM occur each year in the US and the larger EU member states.
  3. MPM survival is influenced by disease stage patient age and overall health and management is largely palliative and multimodal combining surgery radiotherapy and chemotherapy.
  4.  The primary objective of the study is to determine the safety and tolerability of SEPREHVIR when given both as single and repeat intrapleural doses in patients with inoperable malignant pleural mesothelioma (MPM); a form of lung cancer that is almost exclusively caused by occupational exposure to certain types of asbestos.

For further information on the Phase I/II SEPREHVIR(R) study concerning a possible new treatment for patients diagnosed with pleural mesothelioma see this page, “A study looking at HSV1716 to treat mesothelioma”, at the Cancer Research UK web site.


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Medical Research Development: EPHB2 Found To Be Significantly Elevated In Malignant Pleural Mesothelioma Tumors According To September 2013 Journal of Thoracic Oncology Article

The International Association for the Study of Lung Cancer (IASLC) is making people aware of a recent medical research development that may have benefits as regards possible new treatments for malignant pleural mesothelioma.

From this article, “Researchers find potential new target to treat malignant pleural mesothelioma”:

… researchers from the New York University Langone Medical Center looked at EPHB2 in 34 malignant pleural mesothelioma tumors , and found it significantly elevated in tumor tissue compared with matched normal peritoneum. They found EPHB2 overexpressed in all malignant pleural mesothelioma cell lines, but not in benign mesothelial cells. EPHB2 is also significantly elevated in malignant pleural mesothelioma tumor tissue compared with matched normal peritoneum.

Researchers believe, “targeting EPHB2 might provide a novel therapy to improve the prognosis in people suffering from malignant pleural mesothelioma….”

As pointed out elsewhere in that article:

Malignant mesothelioma is a rare asbestos-associated malignancy with limited therapeutic options. Despite advances in the treatment, the median survival remains 12 months from the time of diagnosis.

We will continue to watch for new possible mesothelioma treatments and report significant developments here.


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New Medical Journal Article Presents Two Case Reports Involving Pericardial Mesothelioma And Suggests This Type Of Malignant Mesothelioma Is Not Always Related To Asbestos Exposure

From a summer 2013 edition of Case Reports in Oncological Medicine we get an interesting article about two patients diagnosed with pericardial malignant mesothelioma.

The first case involved a 57-year old man with a two-month history of dyspnea on exertion and dizziness and three days of rapidly progressive dyspnea. His past medical history was unremarkable.

The second case a 27-year-old man presented with chest pain and was treated as tuberculous pericarditis because he presented with constrictive pericarditis with lymphocytic pericardial effusion. His past medical history was unremarkable, also.

From this recent medical journal article, “Malignant Mesothelioma of the Pericardium: A Report of Two Different Presentations”:

Abstract

Malignant mesothelioma of the pericardium is a rare and fatal condition that clinicians should be aware of due to its variability of clinical manifestation. The diagnosis may be delayed as a result of delayed treatment. Here, we report two cases of malignant pericardial mesothelioma with two different clinical aspects: cardiac tamponade and mimic tuberculous pericarditis. Both patients: may have indirect exposure to asbestos. Despite chemotherapy, both patients died at 2 weeks and 3 months after the diagnosis. Malignant mesothelioma of the pericardium is fatal, has a variety of presentation, and may not be related to asbestosis exposure.

1. Introduction

Malignant pericardial mesothelioma is extremely rare and has poor prognosis. It accounted for only 0.3% of mesothelioma death worldwide. Unlike pleural mesothelioma, the relationship between asbestos and this lethal tumor is unclear. Patients usually present with dyspnea on exertion caused by pericardial effusion or heart failure. The characters of pericardial effusion, however, may be different such as cardiac tamponade or constrictive pericarditis. Here, we reported two patients diagnosed as pericardial malignant mesothelioma with two different presentations….

4. Conclusion

Malignant mesothelioma of the pericardium is fatal, has a variety of presentation, and may not be related to asbestosis exposure. CT scan of enhanced soft tissue nodules infiltrating the pericardium may be a clue for diagnosis.

[footnotes omitted]

This medical article also points out that “no standard treatment guideline for pericardial mesothelioma has been established yet.”

We will continue to monitor the medical journals for reports about developments concerning the treatment of malignant mesothelioma, be it for the pleural, peritoneal, or pericardial type of “meso” (as it is sometimes called).


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A great asbestos attorney whom I had the privilege of working for early in my career

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FDA Allows Experimental Cancer Drug VS-6063 To Move Forward And Possibly Be New Mesothelioma Treatment In U.S.

In early July 2013 we wrote this article, “Investigational Mesothelioma Treatment VS-6063 From Verastem Granted Orphan-Drug Status In European Union”, which gave us hope there might be a new treatment for mesothelioma.  The problem was, however, that this VS-6063 experimental cancer drug was not available to patients in the U.S.

We are glad to report, now,  that Veristem has received FDA permission for VS-6063 to move forward and possibly be used to treat mesothelioma patients here.

From this recent news report “Verastem gets orphan drug designation in the U.S.”:

The designation for VS-6063 as a treatment for mesothelioma could mean a faster approval process for the drug and a longer period before competition from generic versions of the drug. It is granted to investigational drugs that address rare diseases for which there is no current treatment.

The Cambridge, Mass., biotech [company Verastem Inc.] develops cancer drugs that work by targeting cancer stem cells. VS-6063 was acquired a year ago from Pfizer after it had already undergone Phase 1 trials to test for safety against several types of cancers. Verastem since discovered it to be effective against mesothelioma, a cancer for which there is only one approved treatment in the U.S.

“Mesothelioma is among the most aggressive and lethal cancers but has limited treatment options,” said [Verastem] President and CEO Robert Forrester in a statement. “We are pleased that the FDA recognizes the significant unmet medical need in mesothelioma.”

Verastem is currently involved with a Phase 1 clinical trial for VS-6063 and has plans for a Phase 2 trial later this year as it takes the necessary procedural and scientific steps towards getting this new cancer drug approved by the FDA as a second mesothelioma treatment here in the U.S.


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North Carolina Bankruptcy Trial: Garlock Says Its Will Pay Only $270 Million While Attorneys For Asbestos Disease Victims Say Company Owes $1.3 Billion On Current And Future Asbestos Claims

Last month we posted our initial report about the Garlock bankruptcy trial, July 2013 Garlock Estimation Trial In North Carolina: Ruling By Bankruptcy Judge George Hodges Rejects Company’s Attempt To Reveal Confidential Claims Information From Other Asbestos Trusts.

That trial is continuing this month, and we get an update from this August 3, 2013 article from the Charlotte Observer, “Billion-dollar asbestos fight underway in Charlotte court”:

The company filed for Chapter 11 protection in 2010, one of dozens of otherwise solvent businesses that turned to the courts for help in settling thousands of claims of asbestos poisoning.

To get out of bankruptcy, Garlock must come up with a figure to cover future payments to those who blame company products for their cancer or other illnesses.

In its filings, Garlock placed that liability “at or near zero.” It says its products are safe but has agreed to set up a $270 million trust fund to cover claims.

A committee of attorneys representing victims said the company’s estimate “has no foundation in reality.”

It is up to U.S. Bankruptcy Judge George Hodges to make the final determination about how much Garlock should pay to its so-called “Asbestos Trust” which is intended to pay current and future victims of asbestos diseases such as malignant mesothelioma and asbestos-related lung cancer.

We will be watching for Judge Hodges’ ruling about the Garlock asbestos liability amount the company needs to pay in order to emerge from Chapter 11 bankruptcy.


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July 2013 Garlock Estimation Trial In North Carolina: Ruling By Bankruptcy Judge George Hodges Rejects Company’s Attempt To Reveal Confidential Claims Information From Other Asbestos Trusts

We have been monitoring the former asbestos company Garlock Sealing Technologies’ bankruptcy estimation trial that started July 22, 2013 in Charlotte, North Carolina and being presided over by federal bankruptcy judge George Hodges.

On the second day of this Garlock bankruptcy trial came the first significant ruling, as reported by HarrisMartin Publishing in this article, “Bankruptcy Judge Denies Garlock’s Attempts to Remove Confidentiality Designations for Asbestos Trust Claim Details” (7/23/13, subscription required):

The bankruptcy judge overseeing the estimation trial on Garlock Sealing Technologies’ liabilities for future mesothelioma claims has rejected the asbestos defendant’s attempts to remove confidentiality designations from evidence relating to asbestos trust claims, HarrisMartin is reporting.

The U.S. Bankruptcy Court for the Western District of North Carolina reached the decision this morning, sources said. Garlock had claimed in its motion to remove the designation that “the problem of discrepancies between tort disclosures and Trust claims and other bankruptcy filings has become an issue of major public concern.”

For some background information regarding this ongoing estimation trial concerning the Garlock asbestos bankruptcy and for more about the company’s attempt to reveal confidential claims information from other asbestos trusts we refer you to this July 21, 2013 Wall Street Journal article, “To Fight Asbestos Cases, Garlock Uses Other Claims as Defense”, from which we get these basic facts:

Garlock filed for Chapter 11 protection in 2010 under the crush of thousands of lawsuits from people who had inhaled cancer-causing asbestos fibers and pinned the blame on working with its gaskets and packing materials….

A special provision of the bankruptcy code was created to allow companies to shed asbestos liability by setting up trusts to pay the claims of people who fall ill in the future.

Garlock estimates its future claims will total $125 million; the claimants committee predicts claims against Garlock will reach about $1.3 billion.

We will continue to monitor the Garlock asbestos bankruptcy estimation trial here in North Carolina and report significant developments here.


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Pfizer-Quigley Bankruptcy Plan Approved By Judge Bernstein In June 2013 Stills Needs Hearing By New York Federal District Judge In Order To Be Finalized

A July 12, 2013 article published by the Dow Jones Bankrutpty News, “Pfizer on Track to Shake Off Quigley Asbestos Claims”, provides a good summary of the situation:

In all, Pfizer paid $1.25 billion to large groups of asbestos plaintiffs outside of the bankruptcy process, according to Schulte Roth & Zabel LLC , the firm that represented Quigley through a bankruptcy that began in 2004. Quigley’s Chapter 11 plan calls for Pfizer to contribute an additional $964 million worth of cash, insurance and other assets to fund a trust that will pay asbestos personal-injury claims….

Judge Bernstein, who rejected an earlier version of the Quigley plan in part due to settlements that swayed plan-voting results, confirmed Quigley’s Chapter 11 plan June 26 at a hearing in the U.S. Bankruptcy Court in Manhattan. Because Quigley’s Chapter 11 plan resolves personal injury claims, it must be approved by a federal district judge as well.

Tuesday, Quigley started the process of getting a federal judge to sign off on the Chapter 11 plan, filing papers in the U.S. District Court in New York that say the sole objector to the plan when it was considered by the bankruptcy court has said it will not appeal.

The confirmed plan boosts Pfizer ‘s contribution to the trust and follows a separate $860 million settlement with asbestos claimants that had blocked the earlier plan.

If and when the Pfizer-Quigley bankruptcy plan is put into effect, the many thousands of asbestos claims filed against Quigley in the past (if still unresolved) and all new cases going forward will be channeled into an asbestos trust fund and away from the court system.


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Investigational Mesothelioma Treatment VS-6063 From Verastem Granted Orphan-Drug Status In European Union

As reported online June 13, 2013 by the Wall Street Journal, “Verastem Investigational Mesothelioma Treatment Gets Orphan Status in EU”:

Verastem Inc. (VSTM) was granted orphan status by European regulators for its investigational treatment for mesothelioma, an asbestos-related cancer with limited treatment options.

The cancer-drug developer, which is focused on developing drugs to treat cancer by the targeted killing of cancer stem cells, also is seeking orphan status for the treatment–known as VS-6063–from the U.S. Food and Drug Administration.

“We are in discussions with regulatory agencies world-wide,” said Verastem President and Chief Operating Officer Robert Forrester. The company plans to begin a trial of the oral treatment–a inhibitor of focal adhesion kinase known as VS-6063–in mesothelioma later this summer, Mr. Forrester said.

A Veristem press release issued that same day, “Verastem Hosts Dr. Dean Fennell for a Mesothelioma Briefing at ASCO”, provides some additional contextual information about this important development:

Dr. Fennell is the Chair of Thoracic Medical Oncology at the University of Leicester incoming President of the International Mesothelioma Interest Group (iMig) and a member of the Verastem Mesothelioma Steering Committee. Dr. Fennell presented together with Verastem Chief Medical Officer Dr. Joanna Horobin and Head of Research Dr. Jonathan Pachter.

“Asbestos is the causative agent in the vast majority of mesothelioma cases” said Dr. Fennell. “Sadly the use of asbestos continues worldwide. Due to the 10-50 year latency period from asbestos exposure to development of disease we expect that the current trend of increasing mesothelioma incidence worldwide will continue. There is a large unmet medical need in mesothelioma and an opportunity to develop targeted agents to bring new hope to patients struggling with their disease.”…

“We are moving quickly to bring new treatment options to patients with mesothelioma” said Dr. Horobin. “Our lead compound VS-6063 is an orally-available agent that inhibits the Focal Adhesion Kinase or FAK pathway….

Approximately 40-50% of mesothelioma patients lack Merlin and studies by Verastem and others have shown that Merlin-low mesothelioma cells and tumors appear to be particularly sensitive to FAK inhibition.

We will watch for clinical trial study findings as regards this new mesothelioma treatment VS-6063 as well as other investigational mesothelioma treatments.


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Experimental Mesothelioma Treatment Drug Shows Promise For Slowing Disease Progression In Some Patients

In November 2012 the Science Codex web site posted this article of interest, “Mesothelioma drug slows disease progression in patients with an inactive NF2 gene”.

This article is significant because it reported that preliminary findings from the first trial of a new drug currently known as GSK2256098 intended for patients with malignant mesothelioma show that this experimental treatment has had some apparent success in preventing the spread of mesothelioma in certain patients, specifically those lacking an active tumor suppressor gene called NF2.

These study findings were presented at the 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland, on November 8, 2012.

Here are some of the important points from this article:

Mesothelioma, which is usually caused by exposure to asbestos, has few treatment options and patients usually die within 9-17 months of diagnosis. Previous research has shown that the gene NF2, which produces a protein called merlin, is frequently inactivated in approximately 50% of mesotheliomas. Merlin negatively regulates another protein called focal adhesion kinase (FAK) in mesothelioma, and so when NF2 and merlin are inactivated, the activity of FAK is increased and mesothelioma cells become invasive and start to spread. When NF2 and merlin activity is restored, FAK activity and cell invasion are decreased.

Professor Jean-Charles Soria, Professor of Medicine and Medical Oncology at South Paris University and head of early drug development at the Institut Gustave Roussy in Paris (France), said: “This suggested that if we could inhibit FAK in mesothelioma patients, it might slow or stop the spread of the disease. Pre-clinical work has shown that an agent, currently known as GSK2256098, is a potent and specific inhibitor of FAK….

However, in patients in whom merlin was inactivated, the average time before the disease progressed was 24 weeks, compared to 11 weeks in patients with active merlin and nearly 11 weeks in patients in whom the activity of merlin was unknown….

“These findings are important but preliminary,” said Prof Soria. “They show that merlin is a potential biomarker in mesothelioma that may enable us to identify a subset of patients who could benefit from GSK2256098 and have longer, progression-free survival. Mesothelioma is a deadly disease without many treatment options, and therefore identification of novel and effective therapies is needed.”

We will watch for further study findings as regards this new mesothelioma drug GSK2256098 as well as other experimental mesothelioma treatments.


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