ONCOS-102 Mesothelioma Clinical Trial Promises Hope

Scandinavian-based Targovax launched the latest immunotherapy clinical trial for pleural mesothelioma, hoping it delivers a better way to treat patients with asbestos-related diseases.

The randomized phase Ib/II trial evaluates the performance of ONCOS-102, an engineered human adenovirus designed to induce systemic, anti-tumor responses.

Researchers are administering the immunotherapy drug as first-line therapy in combination withchemotherapy using pemetrexed and cisplatin.

“Based on what we’ve seen in our first study of patients with various solid tumor types, which is good tolerance and response in a couple of mesothelioma patients, we’re quite hopeful for something positive from this trial,” Dr. Magnus Jaderberg, chief medical officer at Targovax, told Asbestos.com. “There is a lot of excitement.”

Doctors will inject ONCOS-102 directly into the tumor lesions of the pleura, the thin lining around the lungs. Each patient in the multicenter trial will receive six treatments in a five-month period. The trial involves 30 mesothelioma patients.

How Does ONCOS-102 Work?

The virus is engineered to replicate only in tumor cells while leaving normal cells unharmed.

That process breaks down cancer cells, which release specific tumor signals picked up by immune cells. Those immune cells then find and attack the tumor.

Because ONCOS-102 is derived from an adenovirus, it produces minor flu-like symptoms, such as chills and fevers, which may last a few days.

Impressive Tumor Reduction in Early Phase

The clinical trial’s first patient in Barcelona, Spain, received his initial immunotherapy dosage in June. France, Italy and the U.K. also are serving as host sites for the clinical trial.

Optimism about the drug stems partially from an earlier phase I trial in Finland involving various solid tumors and progressive disease that no longer responded to chemotherapy.

ONCOS-102 elicited a 40 percent disease stabilization rate across all tumor types in that trial. The study group included two mesothelioma patients who responded well. One of those patients showed a 47 percent reduction in tumor size.

Also in Finland, a compassionate-use program of ONCOS-102 that allowed access to the yet unapproved drug included 115 patients with various solid tumors such as mesothelioma. Because it was not a controlled study, there were no definitive conclusions, but Jaderberg reported patients exhibited good tolerance and clinical responses to the drug.

Last summer, a preclinical animal study involving mesothelioma tumor cells also demonstrated synergy between ONCOS-102 and the same chemotherapy combination.

“Mesothelioma is known as a highly malignant disease which is usually diagnosed too late for surgery, and as a result, there is very little that patients can be treated with,” Jaderberg said. “New therapies are needed. We hope our immunotherapy can provide additional benefit to standard of care chemotherapy.”

Currently, the U.S. Food and Drug Administration has no approved second-line treatments for mesothelioma patients with unresectable disease.

Immunotherapy Critical to the Future of Cancer Treatment

The phase I study induced tumor specific immune activation at systemic and lesional levels linked to clinical benefit.

Most medical professionals believe the future of cancer care rests in immunotherapy drugs that use a patient’s own immune system to fight off disease. There are dozens of immunotherapy drugs now in the developmental pipeline.

Patients generally tolerate immunotherapy drugs well and without the harsh side effects of typical chemotherapy. These drugs initially complement traditional multidisciplinary treatment that may include surgery, radiation and chemotherapy.

Targovax also is planning to launch trials of ONCOS-102 later this year for melanoma, prostate cancer and ovarian cancer. The melanoma and ovarian cancer trials will include sites within the United States.

“Based on data we have generated so far, I would say there is a good chance that we will find solid tumors where we will show enhanced efficacy,” he said. “I hope one of those will be mesothelioma.”

"Mesothelioma" is the term used to describe a cancerous tumor which involves the mesothelial cells of an organ, usually the lungs or abdominal organs.

Mesothelioma is a rare form of cancer. It is used to describe a cancerous tumor which involves the mesothelial cells of an organ, usually the lungs or abdominal organs.

The most common type of mesothelioma is the pleural mesothelioma. The pleura is a thin membrane found between the lungs and the chest cavity. It provides a lubricated surface so that the lungs do not chafe against the chest walls. Thus, a pleural mesothelioma is often referred to as a “lung” cancer.

Another form of mesothelioma is the peritoneal mesothelioma. The peritoneum is the membrane that encloses the organs of the abdomen. While peritoneal mesothelioma is less common than pleural mesothelioma, it tends to be more invasive, and may thus result in a shorter life expectancy for the patient. Mesothelioma has also been found in the stomach and other abdominal organs.

Why Me?

A common question posed by persons afflicted with mesothelioma is, “Why did this disease develop in me?” The answer is nearly always the same-exposure to asbestos. When diagnosed in the United States, its onset is typically linked to a history of exposure to asbestos fiber. Asbestos is a mineral that was used for decades as a thermal insulation material. It has been widely known since the 1920’s that asbestos is a carcinogen, which means that it causes cancer in humans. However, asbestos was used as an insulator until the mid-1970’s, andis still present in massive quantities in many buildings today. Unfortunately, in many cases very little exposure is required to set this cancer in motion.

Mesothelioma symptoms can be very general and therefore they are often ignored. In most cases, symptoms for this type of cancer arise 2 to 3 months before the cancer is found.

Management of mesothelioma depends largely on the staging of the tumor. Early diagnosis and surgical intervention may lengthen life expectancy. Depending on the age and physical condition of the patient, however, surgery may not be a viable option. In addition to surgical options, radiation treatment and chemotherapy may be helpful in the overall therapeutic program. Pain management and home care are typical alternatives in the later stages of the disease.

See below to learn about the respective symptoms of each type of mesothelioma.

Peritoneal mesothelioma symtoms include:

- Wight loss
- Vomiting
- Nausea
- Belly pain

Pleural mesothelioma symptoms include:

- Trouble swallowing
- Tireness
- Weight loss
- Progressive loss of appetite’
- Fluid in the ches cavity called “Pleural effusions”
- Pain at the side of the chest or the lower back
- Fever
- Difficulty sleeping
- Cough

Where Do I Go From Here?

After diagnosis, it is important to understand your treatment options. Your doctor or oncologist will provide you with information on the treatments that are available to you.

It is also important to know about your legal rights. If you have mesothelioma, or any other asbestos-related disease, you were most likely exposed to asbestos. Many of the manufacturers of asbestos insulation products knew for decades that asbestos was hazardous, yet made a business decision not to warn people of those hazards. As a result, you may have a right of recovery against those manufacturers, which can help defray the costs of treatment and provide compensation for your pain and suffering.

For information on the legal implications of mesothelioma and other asbestos-related diseases, please Contact Us.

Asbestos Related to Most Common Kidney Cancer

Exposure to asbestos may lead to renal cell carcinoma, the most common type of kidney cancer, an Italian study shows.

The link to kidney cancer adds to the horrific history of asbestos, a substance definitively recognized as a cause of mesothelioma, lung cancer and a variety of other respiratory illnesses.

In the past, a handful of other cancers were inconclusively linked to asbestos exposure. However, the research team at the University of Pavia in Italy made its case for asbestos as a probable cause of renal cell carcinoma.

“The findings did surprise me. It was something I had not suspected before,” Stefano Candura, Pavia professor and lead author of the study, told Asbestos.com. “This was a case report on a controversial issue. It may imply that asbestos is a multitarget carcinogen.”

Asbestos Causes Both Malignancies

Scientific journal La Medicina del Lavoro published the study earlier this year.

The case involved a 76-year-old man with seven years of occupational exposure in a factory, where his duties included cutting asbestos cement panels with an electric saw.

Doctors diagnosed him with kidney cancer and removed the diseased organ. Fourteen months later, he died of peritoneal mesothelioma, a cancer which begins in the lining of the abdomen.

It is a rare, aggressive cancer, and the second most common form of mesothelioma. Peritoneal mesothelioma is diagnosed in fewer than 500 people annually in the U.S.

“Asbestos might be involved in the causation of both malignancies,” Candura wrote in the study. “A causal role of occupational asbestos exposure in the genesis of kidney cancer is supported by several case-control and cohort studies.”

The Italian study marks the second time scientific literature includes a reported case associating kidney cancer and peritoneal mesothelioma. It’s a rare combination. A Japanese study first noted the relationship in 2007.

Although it is not unusual for peritoneal mesothelioma to metastasize and invade abdominal organs, the study shows there was no evidence of metastasis involving the diseased kidney.

Asbestos Exposure Is Not a Well-Known Risk Factor

Obesity, smoking and genetic predisposition are typical risk factor for kidney cancers.

Some studies have included an association with exposure to several industrial chemicals. Asbestos is mentioned by some epidemiologists.

Many previous patient autopsies have shown the presence of asbestos fibers in the urinary tracts. The kidneys of patients heavily exposed to asbestos contained large amounts of the mineral’s fibers.

“It is conceivable that the two malignancies share some etiologic factors,” the authors of the Italian study wrote. “Asbestos is the most likely candidate. While the role of this agent in the causation of mesothelioma is well established, evidence for a carcinogenic effect on the kidney is conflicting.”

Candura also believes the asbestos and renal carcinoma link could have legal implications withoccupational-related compensation claims and life expectancy predictions.

“There should be greater awareness that peritoneal mesothelioma and renal carcinoma may occur concurrently,” the authors wrote. “The presence of MM [malignant mesothelioma] may in fact prevent accurate recognition of the concomitant kidney neoplasm, and vice versa.”

"Mesothelioma" is the term used to describe a cancerous tumor which involves the mesothelial cells of an organ, usually the lungs or abdominal organs.

The most common type of mesothelioma is the pleural mesothelioma. The pleura is a thin membrane found between the lungs and the chest cavity. It provides a lubricated surface so that the lungs do not chafe against the chest walls. Thus, a pleural mesothelioma is often referred to as a “lung” cancer.

Another form of mesothelioma is the peritoneal mesothelioma. The peritoneum is the membrane that encloses the organs of the abdomen. While peritoneal mesothelioma is less common than pleural mesothelioma, it tends to be more invasive, and may thus result in a shorter life expectancy for the patient. Mesothelioma has also been found in the stomach and other abdominal organs.

Why Me?

A common question posed by persons afflicted with mesothelioma is, “Why did this disease develop in me?” The answer is nearly always the same-exposure to asbestos. When diagnosed in the United States, its onset is typically linked to a history of exposure to asbestos fiber. Asbestos is a mineral that was used for decades as a thermal insulation material. It has been widely known since the 1920’s that asbestos is a carcinogen, which means that it causes cancer in humans. However, asbestos was used as an insulator until the mid-1970’s, andis still present in massive quantities in many buildings today. Unfortunately, in many cases very little exposure is required to set this cancer in motion.

Mesothelioma symptoms can be very general and therefore they are often ignored. In most cases, symptoms for this type of cancer arise 2 to 3 months before the cancer is found.

Management of mesothelioma depends largely on the staging of the tumor. Early diagnosis and surgical intervention may lengthen life expectancy. Depending on the age and physical condition of the patient, however, surgery may not be a viable option. In addition to surgical options, radiation treatment and chemotherapy may be helpful in the overall therapeutic program. Pain management and home care are typical alternatives in the later stages of the disease.

See below to learn about the respective symptoms of each type of mesothelioma.

Peritoneal mesothelioma symtoms include:

- Wight loss
- Vomiting
- Nausea
- Belly pain

Pleural mesothelioma symptoms include:

- Trouble swallowing
- Tireness
- Weight loss
- Progressive loss of appetite’
- Fluid in the ches cavity called “Pleural effusions”
- Pain at the side of the chest or the lower back
- Fever
- Difficulty sleeping
- Cough

Where Do I Go From Here?

After diagnosis, it is important to understand your treatment options. Your doctor or oncologist will provide you with information on the treatments that are available to you.

It is also important to know about your legal rights. If you have mesothelioma, or any other asbestos-related disease, you were most likely exposed to asbestos. Many of the manufacturers of asbestos insulation products knew for decades that asbestos was hazardous, yet made a business decision not to warn people of those hazards. As a result, you may have a right of recovery against those manufacturers, which can help defray the costs of treatment and provide compensation for your pain and suffering.