TODAYS DATE: September 02, 2010 YOUR ONLINE NEWS RESOURCE FOR ALL THINGS MESOTHELIOMA: PATIENTS, FAMILIES, PROFESSIONALS

Contributing Author

Mike Dayton is a licensed attorney and the former editor of North Carolina Lawyers Weekly and South Carolina Lawyers Weekly. He has contributed numerous articles to the North Carolina State Bar Journal and is a co-author of Capital Lawyers, a history of the Wake County (NC) Bar.

Jennifer Glatt is a freelance editor and writer. She has written and edited articles in both regional and national publications, including the North Carolina State Bar Journal. She lives in Wilmington, N.C.

Nancy Meredith is a blog writer with more than 20 years of professional experience in the Information Technology industry. She lives in Wake Forest, N.C.


Mesothelioma Patient Profile: Charlene Kaforey

Monday, June 30, 2008

We have traditionally used the “Recent News” section of this website to report on the latest findings in mesothelioma and asbestos research. Most of the stories we’ve covered have been summaries of the latest articles from scientific journals, so the content has been fairly technical. We will continue to report on all of the latest research, but we are also expanding the coverage to include stories about people who are living with mesothelioma. Research into the disease only exists because of the people who are battling it, so we want to highlight the men and women who are bravely fighting pleural mesothelioma and peritoneal mesothelioma, as well as the other, more rare forms of the disease: pericardial mesothelioma and reproductive mesothelioma.

Introduction

Charlene Kaforey is a woman from New York diagnosed with pleural mesothelioma in July of 2007. She is currently undergoing immunotherapy under the guidance of a cancer center in the Bahamas and is responding very well to the treatment. We are proud to be able to tell Charlene’s story and believe her fight against mesothelioma is an inspiration to everyone diagnosed with the disease.

Diagnosis of Mesothelioma

Charlene underwent an abdominal CT in March of 2007 which revealed abnormal spotting in her lower left lung. Her doctors then scheduled a follow-up chest CT the following May, which showed even more spotting. Charlene’s doctors initially suspected lymphoma, but when this was ruled out they wanted to take a wait-and-see approach and then re-examine her in six months. Many people may have simply taken the doctors’ advice and waited, but Charlene demanded a lung biopsy and was given one. Her strength and independence of mind, on display here, will be seen throughout her story.

The results of Charlene’s lung biopsy shocked everyone involved, but her most of all. The biopsy revealed she had pleural mesothelioma and then further testing discovered it had spread to her lymph nodes, which is a sign of more advanced disease. Charlene thus found herself as a Stage III patient for a disease she had barely heard of. Not sure of just how to proceed, she soon began chemotherapy after consulting with some of the finest mesothelioma physicians in New York and Boston, who recommended that she complete the traditional, trimodal mesothelioma treatment protocol of surgery, chemotherapy and radiation. However, Charlene was not sure if trimodal therapy was in her best interest. She consulted with her personal physicians and they, too, agreed that the standard therapies were probably not for her. In describing her decision, Charlene said, “When I looked at the research papers, I realized that the conventional approach of surgery, chemo, radiation, would likely give me at most 30 months, and more likely 12-18 months. I had very few symptoms. For me, surgery meant giving up my ‘good health’ forever and then probably having a short survival afterward. It didn’t make sense. Why go through all of that for the little time it gives in return?”

Mesothelioma Treatment with ITL Alternative Cancer Treatment Clinic

This is another example of Charlene’s independence and inner strength. Instead of beginning trimodal theory, Charlene researched alternative mesothelioma treatments and soon found information about the ITL Alternative Cancer Treatment Clinic, a cancer clinic located in the Bahamas that specializes in Immuno-Augmentative therapy, which is treatment that attempts to train the body’s own immune system to fight off the cancer. While this treatment is considered experimental by conventional medicine, ITL has been successfully treating cancer patients with this therapy for over 30 years. When Charlene discovered ITL, she continued to read more and more about the Clinic and its methods and she also took the opportunity to speak with other patients under ITL’s care. She recalled, “When I found the clinic, I talked to women with meso who were out 6 years from diagnosis with more advanced initial cases then mine. It was reason for hope.” Charlene then applied for the treatment through the clinic’s website and was notified of her acceptance into the program a few days later. With renewed hope, Charlene then began to plan for her travel to the Clinic.

ITL is located in the Bahamas, so patients who are accepted into the program must travel to the Bahamas for an eight week initial visit and then must return every 4 months for two weeks at a time. The Clinic itself is an outpatient facility, so people who come to the Bahamas for ITL must secure lodging at a site off the ITL campus. During Charlene’s stays at the Clinic, she has blood drawn every morning which is then analyzed and used to develop the serum and vaccine injections that she will be given to treat her mesothelioma. After the first eight week visit and then each subsequent two week visit, she returns home with sixteen weeks worth of medicine. When she completes this treatment cycle, she returns again to the clinic for a follow-up and the next round of injections, and will continue this process again and again.

When she’s home, Charlene personally manages her treatment injections. She makes six to twelve daily injections of the Immuno-Augmentative therapy, as well as weekly intravenous Vitamin C treatments. When she began therapy, Charlene also received 12 weeks of bi-weekly injections of dendritic cell and heat shock protein vaccines. ITL makes clear that their therapies are not a cure for one’s cancer, but are treatments that train the body’s immune system to mange the cancer and to contain its growth. This system requires one to make these injections for the rest of one’s life. Because of this, Charlene, and others patients at ITL, liken their Immuno-Augmentative treatments to insulin injections for diabetics.

Positive Results of Treatment

When we asked Charlene how the treatment was working for her, she said that her initial results have been very positive. She recently completed her first CT scan since beginning treatment and it has revealed less visible cancer, as well less fluid build-up and less pleural thickening than previously seen. Her physician team back home is excited about her progress, especially her oncologist, who is encouraging her to keep up with the treatments.

Not only is the treatment working, but it’s doing so without any significant side effects. Although some people are often quite tired when beginning the treatments, Charlene said she hasn’t had any treatment effects and feels better overall, especially when compared with the side effects she experienced undergoing chemotherapy.

Hope

We couldn’t be happier for Charlene and her family now that she is responding well to the treatment. A diagnosis of mesothelioma can be a devastating event for any family, but innovative doctors are doing everything in their power to change the treatment equation that has historically been characteristic of mesothelioma. Not everyone may respond to ITL’s treatments, but many people have responded and for them, ITL has offered the one thing that is so rarely found among people undergoing mesothelioma treatment: hope.

Hope is also what emerges most from Charlene’s story: hope for her and for her family, as well as hope for other people with pleural mesothelioma who find her story and are inspired by it. Charlene has spoken of the hope that ITL inspired in her and we can now speak of the hope that she may inspire in others as well.

When we asked Charlene if she would recommend ITL to others, she enthusiastically responded that she would. Her words here are a fitting conclusion to this story:

“I am thrilled with my results so far, even my oncologist said ‘its working! Keep doing it!’ … I have met so many patients there [ITL] with great success stories. I now have confirmed positive results as well. I would strongly recommend this to others. Any one with cancer needs to give it serious consideration.”

We hope Charlene and her family the best.

Disclosure: Charlene Kaforey is a client of Belluck & Fox and is presently engaged in litigation related to her mesothelioma.

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MR Imaging of Benign and Malignant Pleural Disease

Thursday, June 26, 2008

Source: Magnetic Resonance Imaging Clinics of North America

Radiological imaging technologies are among the most important tools available for the diagnosis of mesothelioma and other forms of cancer, as they can render the status and structure of the interior landscape of a patient’s body without the need for invasive, exploratory surgery. Since the original discovery of x-ray technology in 1895, a number of elaborations on imaging technology have taken place and contemporary medicine regularly utilizes the following imaging modalities for cancer diagnosis in general and mesothelioma diagnosis in particular: x-ray, computed axial tomography (CAT or CT scanning), magnetic resonance imaging (MRI) and positron emission tomography (PET). Each technology has its own individual strengths and weaknesses and its own appropriate use in the diagnosis of disease.

Research into the efficacy of these technologies for the diagnosis of pleural mesothelioma and peritoneal mesothelioma is regularly being conducted, as improvements in a physician’s ability to diagnose mesothelioma can often mean the difference between an early-stage diagnosis and a late-stage one. When these technologies are compared as a group, x-ray generally represents the first technology used for a diagnosis of chest-related issues and then CT is used to investigate whatever is found on the chest x-ray. CT is much more sensitive than is x-ray to tissue structures and represents the first level at which abnormalities in the pleural surfaces can actually be visualized. CT is considered the standard diagnostic tool for mesothelioma and is used in multiple ways in the management of the disease. However, CT does have limitations in its ability to resolve fine tissue structures, so MRI can be used post-CT to confirm CT findings and/or to answer questions that CT is unable to answer.

The extent to which MRI should be used in the diagnosis of mesothelioma is a particularly active area of investigation and physicians from Boston’s Brigham and Women’s Hospital have recently added to the literature on the subject with an article summarizing the use of MRI for pleural imaging in general and for mesothelioma in particular.

Introduction

The pleura are thin, finely-structured tissues that are difficult to visualize in the absence of disease. The parietal pleura lines the chest wall, while the visceral pleura encases the lungs. Each surface is separated by a small area, known as the pleural space, where a lubricating fluid is secreted into. This fluid allows the lungs to more easily expand and contract and move around the restricted space in which it lives. Taken together, the pleural space and the individual tissues have a combined thickness of only .2–.4 mm, which means that technologies attempting to image these areas must demonstrate high enough resolution to provide adequte detail of the pleural structures if the scans are to serve a diagnostic function. Traditional x-ray does not have sufficient resolution for this purpose, but CT and MRI have both demonstrated great utility for the diagnosis of pleural mesothelioma, as well as other diseases and disorders of the pleural cavity.

CT and MRI work according to different underlying technologies, but they share a common goal of providing doctors with important information about the interior structures of certain parts of the body. CT is the standard modality employed as a first-line tool for the diagnosis of mesothelioma, while MRI often represents the next step in the management workflow. The principal difference between the quality of the images generated by each technology revolves around contrast—specifically, soft tissue contrast. For this purpose, MRI is a markedly superior technology. Both technologies can visualize the basic structure of the body’s interior surfaces, but MRI’s better contrast makes it more effective for diagnosing the differences between and within tissue structures, as well as for visualizing the extent to which these structures have been infiltrated by pleural mesothleioma.

Overview of the Article

The article describes the use of MRI and CT for imaging a number of disorders within the pleural cavity, from pleural effusions to pleural mesothelioma, and it makes a number of recommendations regarding the role that each technology plays within this framework. The authors state that both technologies can be used to image pleural plaques, which are localized, abnormal patches of tissue commonly associated with asbestos exposure, as well as benign and malignant cases of diffuse pleural thickening. In fact, they specifically note that CT and MRI provide similar information in most cases, but MRI’s superior soft tissue contrast means that it can be used as an elaboration of whatever findings are first demonstrated on CT:

MR Imaging is useful to confirm and characterize CT findings, particularly diffuse pleural thickening, pleural effusion, and involvement of adjacent spaces.
(MR Imaging of Benign and Malignant Pleural Disease, p. 335)

The authors also note that MRI’s enhanced contrast makes it especially important for surgical planning.

The article closes with a brief discussion of the use of integrated CT/PET for mesothelioma diagnosis. While certain studies have shown great value in this recent innovation, especially in its ability to visualize distant metastases and occult disease, the authors remained concerned with PET’s ability to finely render specific body structures, which is a clear concern for visualizing the pleura and the other tissues involved with mesothelioma.

The authors conclude their article by asserting CT’s primary role in the medical management of pleural diseases; but they follow this with an explicit affirmation of the importance that MRI plays in the diagnosis, staging and treatment of pleural mesothelioma.

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Public Heath Advocates Form Committee to Ban Asbestos in America

Monday, June 23, 2008

Source: Business Wire

The Asbestos Disease Awareness Organization (ADAO) and The John McNamara Foundation have announced the formation of the Committee to Ban Asbestos in America (CBAA), an advocacy group dedicated to preventing asbestos exposure and eliminating asbestos-caused diseases. The CBAA, along with its constituent organizations, supports the asbestos ban that is currently being reviewed by the House Energy & Commerce Subcommittee on Environment & Hazardous Materials.

In the press release announcing the formation of the Committee, ADAO and CBAA chairperson Linda Rothstein is quoted as “We are calling on the U.S. Congress and the President to do the right thing and ban asbestos in America and fund critical medical programs. Doctors and scientists agree: asbestos is a carcinogen and that there is no safe level of exposure. Preventing asbestos exposure is the only way to eliminate asbestos caused diseases.”

The Asbestos Disease Awareness Organization (ADAO) is an organization devoted to the victims of asbestos exposure and their families. ADAO’s goal is to raise public awareness about the dangers of asbestos exposure and they accomplish this through a number of activities, including product safety checking. The John McNamara Foundation is an organization that works to ban asbestos and provides support and assistance to mesothelioma victims.

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Cancer Stem Cells Could Cause Tumors, Be Key to Cure

Wednesday, June 18, 2008

Source: Wired.com

Wired.com is running an article on a theory of cancer development which proposes that most tumor growth is driven by a subset of specialized tumor cells called cancer stem cells and that the key to treating cancer in general is to treat these cells in particular. The theory states that cancer stem cells are responsible for stimulating and directing tumor growth just as traditional stem cells are responsible for stimulating and directing organ and tissue growth. Cancer stem cells would help explain why some cancers return after what appears to be a successful treatment and why others do not: if the treatment removes most of the cancerous cells, but the ones remaining are cancer stem cells, then the tumor is likely to return, but if the ones remaining are not stem cells, then the cancer will die off.

The theory is still controversial within certain aspects of the cancer research community, but it is quickly winning over many former skeptics. As an example of just how important many researchers think these treatments will be, GlaxoSmithKline has signed a $1.4 billion deal with Oncomed, the first company who will be conducting human trials on cancer stem cell treatments, for the right to commercialize and market the treatments should the trials prove effective. Oncomed’s leading drug candidate, currently known as M2118, is an example of monoclonal antibody therapy and was developed to bind with cancer stem cells and to disrupt the signaling systems they use to stimulate tumor growth. Monoclonal antibodies are antibodies that are created to bind with the receptors of a particular cell or other antigen, to either stimulate an immune system response which subsequently attacks the antigen or to prevent specific signaling structures from becoming engaged. M2118 has been successful in a number of pre-clinical and animal studies, but has not yet been tested on humans. Wired is reporting that M2118 can be combined with other treatments, so its use as part of a combination therapy can hopefully augment the effectiveness of both treatments.

Oncomed expects to be begin human trials of M2118 later this year, so by early 2009 researchers should have at least a partial data set by which to examine the efficacy of M2118 in particular and of cancer stem cells in general. Studies using mouse models have shown that these cancer stem cells are active in mice and can be treated therapeutically as well, but even Oncomed CEO Paul Hastings knows that success in these murine models is no guarantee of success in human trials. All in all though, Wired quotes Hastings as saying that the company was looking forward to beginning these human trials.

Cancer stem cells represent the latest attempt to solve the problems of cancer once and for all. As cancer is a family of diseases and not a single disease, it is difficult to imagine that a single therapy will be effective across the entire spectrum of cancer disorders; however, cancer stem cells have generated a significant amount of interest in a relatively short period of time and they do represent a fundamentally new class of treatment. Just how effective these treatments are will not be known for months, and probably years to come, but the fight against cancer is being conducted on a number of promising fronts these days and there is real hope among doctors and patients alike that improving treatments are finally changing the dynamics involved in cancer therapy.

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Cancer as a Disease, Not a Death Sentence

Tuesday, June 17, 2008

Source: New York Times.com

The New York Times is running an article on how recent advancements in cancer treatments are changing the view that doctors and patients take towards the meaning of the disease. A diagnosis made just ten years ago that was likely to lead to a patient’s death is now just as likely to be treated within a framework of chronic disease management where the patient continues to live a full and active life. As medicine learns more about the biological structures that are responsible for tumor development, doctors are more able to develop long-term treatment plans that incorporate this knowledge. The model that many of these physicians now see as appropriate in guiding the overall view towards cancer treatment is the model employed for diabetes management: not necessarily curable, but completely treatable.

The basic idea that guides many of these treatments is that the increasing knowledge and research into the disease means that doctors can treat patients with a particular therapy until the patient no longer responds to it, and then just switch that patient to a different therapy that attacks the same problem in a new way. The hope is that this type of model of treatment, known as the “Hitchhiker Model,” can continue on until a true cure is found for an individual’s particular cancer. Even if a true cure is never made available, the creation of new therapies hopefully means that treatments can continue indefinitely.

The Times profiles a number of patients with cancers that until quite recently would have been seen as totally incurable and not at all treatable and yet, who continue to lead full lives. One of those profiled was Elizabeth Edwards, wife of Senator, and former presidential candidate, John Edwards, whose breast cancer has spread to her bones and her lungs, but whose doctors have discovered ways of managing her cancer that will never cure her of the disease, but should be able to control its spread and metastatic potential.

The article closes with a doctor stating that anyone who is given a terminal cancer diagnosis should immediately seek a second opinion at a major cancer center, because the experts employed there may be able to develop a more effective treatment protocol than is currently employed by most doctors.

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59th mesothelioma case reported among miners

Friday, June 13, 2008

Source: Duluth News Tribune

The Duluth News Tribune is reporting that a 59th case of mesothelioma has been identified in the population of Iron Range workers whose extremely high incidence rate of the disease has sparked national attention on Minnesota’s Iron Range. The case was identified when data from the Minnesota Health Department study on the Iron Range workers was recently compared to the data contained in the Minnesota Cancer Surveillance System, which is the State’s cancer registry. The precise nature of this case is still unclear though, as a comparison conducted last year only showed the same 58 cases which sparked the news attention in the first place. No further information on this newly-identified case has been released.

The high number of mesothelioma cases among Iron Range workers has prompted the State to allocate funding to investigate if there is a relationship between the taconite ore that is the region’s major mining product and mesothelioma. Taconite is not an asbestos-form mineral and has not previously been implicated in mesothelioma genesis, but the high number of cases has caused concern among workers and families in the area. Minnesota governor Tim Pawlenty approved nearly $5 million to cover the studies at the end of April.

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Malignant Mesothelioma Resistance to Apoptosis: Recent Discoveries and their Implication for Effective Therapeutic Strategies

Thursday, June 12, 2008

Source: Current Medicinal Chemistry

Mesothelioma is a complex cancer that remains difficult to treat effectively. There is no cure for the disease and the standard therapies, even in the best of cases, can only extend life. Because of this, investigations into the basic physical processes responsible for its development make-up a significant proportion of contemporary research. An understanding of the precise genetic changes and cellular activities that lead to mesothelioma genesis is thought to be the best way to create more effective treatments for patients with pleural mesothelioma, peritoneal mesothelioma and the other forms of the disease.

One of the therapeutic targets this research has identified is mesothelioma’s resistance to apoptosis, which is the process by which damaged or malformed cells are killed off and removed from the cell cycle. The research seems to indicate that one of the reasons mesothelioma may be so difficult to treat, as well as why it acts so aggressively, is the number of ways in which it resists apoptosis. Previous studies have identified some of these processes, but a review of the available literature on mesothelioma and apoptosis has not been completed until recently, when Italian researchers published their review of these previous studies. In their article, published in the journal Current Medicinal Chemistry, the researchers provide detailed information on the various apoptotic inhibitors that have been identified and, where possible, have noted treatment strategies that are either under active investigation or have been proposed for treatment.

Introduction to Apoptosis

Apoptosis is an important part of the regulatory processes that keep the body healthy, so significant apoptotic dysfunction raises the possibility of cancer genesis and subsequent spread due to the continued replication of damaged cells. The process can be activated from signals received outside of the cell, via its extrinsic pathway or from signals generated within the cell itself, via its intrinsic pathway. Apoptosis is triggered via the extrinsic pathway when a specific extracellular ligand, known as a death ligand, binds to its receptor on the cell’s outer surface, known here as the cell’s death receptor, which responds by activating an intracellular enzyme family (the caspases) that is responsible for the processes that lead to the actual termination of the cell. Apoptotic signaling via the intrinsic pathway is triggered in response to the cell’s experience of some form of stress and leads to a similar activation of the caspases.

The entire process is normally tightly regulated, but it can be undermined in a number of ways: by the over-expression of specific proteins and/or growth factors that lead to an inhibition of apoptotic behavior, by an under-expression of other proteins that normally demonstrate pro-apoptotic behavior, as well as combinations of all of these.

Mesothelioma and Apoptosis

The researchers have reviewed the available literature on mesothelioma and apoptosis and they describe a number of the processes that have been shown to inhibit apoptosis in affected cells. Some of these involve basic signaling structures, while others involve more complex situations where growth factor overexpression leads to an up-regulation of proteins which exhibit their own anti-apoptotic behavior. As an example of the former situation, researchers have shown that mesothelioma appears to be less responsive overall to particular signaling structures, such as the binding of TNF-related apoptosis-inducing ligand (TRAIL) to DR4 and DR5 death receptors, as compared to normal cells. The reasons for this are still unclear, but they do note a number of proposed therapies to overcome this lack of responsiveness.

Most of the article, though, is a description of the various proteins and growth factors that have been identified as possible agents in mesothelioma’s resistance to apoptosis. They note two particular protein families that have been especially implicated in this process: the inhibitor of apoptosis proteins (IAPs), a family of proteins that bind with and inhibit certain members of the caspases enzymes so apoptosis cannot occur, and the Bcl-2 family of proteins, whose members actually exhibit both pro- and anti-apoptotic features, but which mesothelioma cells tend to express only those members that promote anti-apoptotic behavior. The authors note that a number of treatments specific to these protein families are under investigation.

The authors also describe the ways in which growth factor overexpression can lead to cancer genesis and the inhibition of apoptosis. Growth factors are special proteins that serve important roles in the regulation of cellular processes and functions, so their misregulation can be especially problematic for long-term health. The authors then describe the roles that Epidermal Growth Factor (EGF), Hepatocyte Growth Factor/Scatter Factor (HGF/SF), Vascular Endothelial Growth Factor (VEGF), Insulin-Like Growth Factors (IGFs) and misregulation of the Wnt signaling pathway may play in mesothelioma’s resistance to treatment.

Each of these growth factors play an essential role in a well-regulated body, but their overexpression has been implicated in mesothelioma and in other forms of cancer as well. For example, EGF plays a vital role in promoting cell survival, but is over-expressed in a number of epithelial cancers and is thought to up-regulate other proteins involved with the inhibition of apoptosis. VEGF is essential for angiogenesis, which is the process by which new blood vessels are formed from existing tissue structures, but is over-expressed in most forms of cancer, including mesothelioma. Both of these examples show how misregulation of the body’s essential functions can lead to serious health-related issues.

Conclusion

The authors conclude their article by noting that the understanding of mesothelioma’s resistance to apoptosis is a recent discovery and they express hope that therapies specific to the identified processes will lead to more effective treatments for patients with the disease.

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Merck’s International Study of Vorinostat (ZOLINZA) in Patients with Mesothelioma Proceeds to Phase III Development

Tuesday, June 10, 2008

Source: Mesothelioma Applied Research Foundation

Merck has recently announced that its clinical trial of Vorinostat as second-line therapy for pleural mesothelioma patients who’ve failed the standard chemotherapy regimen for mesothelioma treatment has moved to Phase III status. Merck is now enrolling patients from cancer centers in the United States and the United Kingdom, as well as in Belgium, Germany, the Netherlands, New Zealand, Spain and Sweden.

Vorinostat, which is marketed as Zolinza, is an anticancer agent that has already won approval by the FDA for the treatment of cutaneous T-cell lymphoma, a type of Non-Hodgkin lymphoma that mainly affects the skin. Vorionstat’s use for the second-line treatment of mesothelioma is being studied in this randomized, double-blind trial, where its safety, tolerability and anti-tumor activity will be compared to a control group given only placebo, along with best supportive care. The primary endpoints of the trial include Vorionstat’s effects on overall survival, as well as an investigation regarding its safety and toxicity. The trial’s secondary endpoints will examine its overall response rate and any demonstration of progression-free survival, as well its effects on dyspnea and forced vital capacity.

The trial is mainly being conducted as an investigation of Vorionstat’s applicability as second-line therapy on patients who have failed the standard therapies of pemetrexed and cisplatin or carboplatin, but its use for patients who are not eligible for a pemetrexed-based protocol will also be investigated.

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With a Tiny Bit of Cancer, Debate on How to Proceed

Monday, June 9, 2008

Source: New York Times

The New York Times Health Section has recently published an article on the debate regarding what the appropriate treatment response should be for the discovery of micrometastatic lymph node involvement in a cancer patient. Doctors have long used lymph node status as an important indicator of patient stage and overall prognosis, as the discovery of cancer cells in lymph nodes means that the cancer could have spread beyond the local region in which primary site tumors were initially found. If cancer cells are found in a patient’s lymph nodes, doctors have traditionally re-staged the patient to a more serious status level in recognition of this possibility of metastatic spread. However, our ability to identify individual cancer cells has advanced to such a degree that doctors find themselves in the difficult position of having to interpret the meaning of very small levels of cancer in the lymph nodes. These small levels are known as micrometastases and the debate surrounding them is one of the most pressing in current cancer research. The debate has been especially active in breast cancer treatment, but all forms of cancer have the potential to metastasize to distant locations in the body, so the issue of micrometastases is likely to be one faced by all cancer patients at some point.

The central question in the debate is “What do these small levels mean,” but there aren’t any answers to this question yet. Even though scientists have been aware of the phenomenon of micrometastases for years, it is only with the technological advances in recent years that doctors have been confronted with how to respond—if at all—to these small levels, so there isn’t any historical guidance on what constitutes a “proper response” to them. A few studies have been done, but most of them demonstrate methodological problems that limit the scope of their conclusions, so much more work is still necessary before any firm conclusions can be drawn. The article notes that two long-term studies are currently underway, but their results will not be available for a few years, so this is a question that will be with us for a while.

Whether the issue is breast cancer or one of the major forms of mesothelioma, such as pleural mesothelioma or peritoneal mesothelioma, doctors will have to determine the meaning to the question of “what is the proper response to micrometastatic lymph node involvement” one patient at a time.

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The European Commission Grants Orphan Drug Designation for Molmed’s Vascular Targeting Agent Arenegyr in the Treatment of Mesothelioma

Friday, June 6, 2008

Source: PharmaLive.com

The European Commission, which is the executive branch of the European Union, has granted “Orphan Drug” status to Arenegyr, an anti-cancer drug currently under investigation for the treatment of mesothelioma, as well as a number of other cancers. Arenegyr is an experimental vascular targeting agent that targets newly-formed tumor blood vessels and disrupts the vascular processes that feed the tumor. At low doses, the agent exhibits its own anti-tumor activity, but it also enhances the efficacy of other anti-cancer drugs used in combination with it. At high doses, it disrupts the vessels and can induce large-scale tumor breakdown and death.

Orphan Drug status is a designation given to therapies designed for uncommon conditions. The EU’s orphan drug status designation is restricted to conditions that occur in less than 5 in 10,000 people. The designation provides a number of benefits to companies developing the therapy and is a given after a therapy has shown some initial successes in clinical trials.

Arenegyr is produced by the Italian pharmaceutical company MolMed S.p.A. and is currently the subject of a number of clinical studies, both as a single-agent therapy and as a combination with therapy. These studies are investigating its use for pleural mesothelioma, colorectal cancer, hepatocarcinoma and small-cell lung carcinoma.

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