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WA team's mesothelioma breakthrough (Kylie Walker, AAP medical
writer )

Blood Test for Mesothelioma (Ivanhoe Newswire)

Pemetrexed Shows Survival Benefit in Patients with Pleural Mesothelioma (The University of Chicago Medical Center)

Patients With Asbestos-Related Cancer Report Better Quality of Life With Alimta+Cisplatin (CHICAGO--(BUSINESS WIRE)--June 2, 2003--)

Lilly's drug for cancer 'exciting' (Indianapolis Star, IN - Jun 2, 2003)

WA team's mesothelioma breakthrough

By Kylie Walker, AAP medical writer
17dec03

NEW hope is on the horizon for the growing number of Australians with the deadly asbestos-caused cancer, mesothelioma.

Caused by the inhalation of asbestos fibres, mesothelioma has been incurable and almost always leads to death.

However, a promising new compound appears to kill the cells of both mesothelioma and another notoriously difficult to treat cancer, melanoma.

Together the lung and skin cancers claim hundreds of Australian lives every year, and federal government health experts predict about 10,000 more mesothelioma cases will be identified in Australia by 2020.

Professor Michael Millward and his team at Perth's Sir Charles Gairdner Hospital hope their research will lead to a new drug that will beat those cancers and others.

They have recently begun human trials of the compound, derived from the herbal medicine known as Devil's Weed.

"Currently, there are two patients and two more are starting shortly," Prof Millward said.

"We will be looking to treat about 18 to 25 patients between now and the second quarter of next year."

Animal and laboratory tests have shown extremely heartening results.

"We're talking about a reduction in tumour size in animals and outright killing of cells in the laboratory," Prof Millward said.

Most existing chemotherapy drugs trigger a self destruct mechanism in cancer cells, but mesothelioma and melanoma cells are largely immune to this kind of therapy.

The new compound works by unlocking a receptor on the cancer cell, invading the cell, then killing it – much like planting an explosive inside the cell.

However, Prof Millward warned cancer patients should not get too excited about the possible new treatment.

"After this phase we will then evaluate all the results and look at if the drug is safe and whether it may be beneficial, and if that's the case we will then go to trials for specific cancers," he said.

"If the next set confirms this is a promising treatment, then it will take several more years of large trials to know if it's going to be a marketable treatment for cancer."

In other cancer news, human trials are expected to start soon for a new drug that was found in animal studies to kill late-stage human prostate cancer cells.

Melbourne-based drug development company Cytopia said its new molecule halted the normal growth cycle of prostate cancer cells, eventually leading to cell death.

The company hoped to start testing the therapy on humans by mid-2004.

Blood Test for Mesothelioma

(Ivanhoe Newswire) -- A new study provides promising results on a blood test to identify people with mesothelioma. Mesothelioma is a deadly tumor of mesothelial tissue surrounding the lungs, often caused by exposure to asbestos.

Malignant mesothelioma is a highly aggressive tumor. The incidence of this cancer is increasing because of widespread exposure of many individuals in developed countries to asbestos. In general, mesothelioma is resistant to chemotherapy and radiotherapy and is rarely cured by surgery. Mesothelioma is also difficult to diagnose.

Researchers from Sir Charles Gairdner Hospital in Perth, Australia, have developed a test to help detect mesothelioma. They say the test looks at the blood concentrations of proteins expressed by mesothelioma cells called soluble mesothelin-related proteins, or SMR. To evaluate the new blood test researchers used serum samples from 44 patients who had mesothelioma and 68 healthy individuals, 40 of whom had been exposed to asbestos. They also tested blood from 160 patients with other malignant lung diseases.

Study authors report the test had a high level of specificity. Overall, 37 of the 44 patients with mesothelioma had raised concentrations of SMR compared with three of 160 patients with other cancers. Also, none of the 28 patients who had not been exposed to asbestos had raised SMR levels. Researchers say the test could also be used to test the progression of the tumor in patients with mesothelioma.

Furthermore, investigators say the SMR test could be used to detect the cancer several years earlier. Of the seven asbestos-exposed individuals who had increased blood concentrations of SMR, three developed mesothelioma and one developed lung cancer. They also say none of the 33 asbestos-exposed patients whose blood samples had normal SMR developed mesothelioma after five years.

Researchers conclude the determination of SMR in serum could be a useful marker for diagnosis of mesothelioma and to monitor disease progression. They say it might also prove helpful in future screenings for early evidence of mesothelioma.

Pemetrexed Shows Survival Benefit in Patients with Pleural Mesothelioma

THE UNIVERSITY OF CHICAGO MEDICAL CENTER

Patients with cancer of the lining of the lung, known as pleural mesothelioma, live longer and have less pain and shortness of breath if they receive the new chemotherapy drug pemetrexed (Alimta R, Eli Lilly), according to the results of a Phase III global study.

The study was presented May 20, 2002, at the annual meeting of the American Society for Clinical Oncology.

Mesothelioma patients who were treated with pemetrexed plus the commonly used chemotherapy drug cisplatin lived for about a year after their diagnosis, nearly three months longer than patients who received only cisplatin, the researchers found. The two-drug combination also caused the cancer to shrink in 41% of patients, compared to 17% of patients who received only cisplatin, and was more effective at reducing pain and shortness of breath, symptoms commonly experienced by patients with this type of cancer.

"The results are very encouraging and significant because mesothelioma patients and their families now have proof that this new chemotherapy drug offers real and tangible benefits," said Nicholas J. Vogelzang, MD, Fred C. Buffett Professor and Director of the University of Chicago Cancer Research Center.

Mesothelioma is most commonly caused by asbestos exposure. Pemetrexed is a cousin of one of the earliest chemotherapy drugs, methotrexate, used for the treatment of other types of cancer. While methotrexate blocks one enzyme necessary for cell division and tumor growth, pemetrexed blocks three such enzymes.

The Phase III randomized study is the largest mesothelioma trial ever conducted, involving 456 patients. Patients were selected at random to receive pemetrexed plus cisplatin or cisplatin alone.

Shortly after the study began, the researchers found that many of the patients were deficient in the vitamins folic acid and B12. The deficiencies, which were presumably caused by the cancer and a poor appetite, decreased the ability of normal cells to repair and produce new DNA. The vitamin-deficient patients who received pemetrexed were more likely to experience severe toxicity (such as very low white blood cell counts [severe neutropenia], severe diarrhea, and severe mouth ulcers [stomatitis] which could lead to death) than patients who received only cisplatin.

Following this observation, all patients in the study received folic acid and vitamin B12 as a standard part of their treatment. This reduced the toxic side effects associated with pemetrexed, and more patients benefited from the drug.

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Patients With Asbestos-Related Cancer Report Better Quality of Life With Alimta+Cisplatin

CHICAGO--(BUSINESS WIRE)--June 2, 2003--

Earlier Findings Showed That Alimta+Cisplatin Helped These Same Patients Live Longer

Patients enduring an agonizing form of cancer often associated with asbestos exposure reported that the combination of Alimta(R) (pemetrexed) and cisplatin enabled them to enjoy a better overall quality of life, compared to cisplatin alone.

The findings - unveiled today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago - come on the heels of data presented at last year's ASCO meeting indicating that Alimta+cisplatin enabled these same exact patients to live longer than if they received cisplatin alone.

"Patients with advanced cancer should not have to choose between feeling better and living longer," said Richard Gralla, M.D., a noted thoracic cancer expert and president of the New York Lung Cancer Alliance, who presented the findings. "Patients, and we as health care professionals, want both."

Gralla characterized the findings as "very good news" in developing a potential treatment for malignant pleural mesothelioma, a disease in which a tumor - caused by asbestos fibers - lodges between the chest wall and lung cavity. "This is a terrible disease with a high mortality rate and is associated with several debilitating symptoms, including crushing chest pain and difficulty breathing," said Paolo Paoletti, M.D., vice president of oncology products at Eli Lilly and Company, which is developing Alimta.

At least 10,000 people worldwide are diagnosed with malignant pleural mesothelioma each year, according to conservative estimates. However, that figure is expected to increase because malignant pleural mesothelioma has a long latency period - 20 to 50 years. There is currently no approved therapy for this disease.

The survival and quality of life data for Alimta resulted from a Phase III randomized study of 448 patients with malignant pleural mesothelioma from 19 countries. Of these patients, 226 received Alimta + cisplatin (a common chemotherapeutic agent) and 222 received cisplatin only.

As previously reported, results showed that combining Alimta with cisplatin increased patients' median survival by 30 percent (12.1 vs. 9.3 months, a finding that was statistically significant). No other chemotherapy studied in malignant pleural mesothelioma, including cisplatin alone, has been able to exceed the six-to-nine month life expectancy for patients diagnosed with this disease.

The quality of life data were reported in detail today for the first time. The data were obtained from the same 448 patients who were tracked for survival.
According to this analysis, patients treated with a combination of Alimta and cisplatin experienced significantly less pain and difficulty breathing, among other symptoms. "Not only is their life prolonged by this treatment, but their quality and enjoyment of it is improved," said Michael Boyer, M.D., head of the department of medical oncology at the Sydney Cancer Center in Australia. "People who were no longer able to do the things they enjoy are once again able to participate in life."

More About The Study

In this study, 77 percent of patients had Stage III-IV, or advanced, disease.
The study's primary endpoint was survival. Quality of life, which takes into account a patient's physical, psychological and social functioning, was a secondary endpoint.

In gathering quality of life data, researchers used an instrument known as the LCSS- Meso Scale. This scale is based on the Lung Cancer Symptom Scale (LCSS), a validated and widely used instrument for measuring quality of life in patients with lung cancer.

In addition to rating their overall level of quality of life, patients were also asked to rate five specific symptoms associated with their disease: pain, shortness of breath, fatigue, appetite loss, and cough. At least 90 percent of patients stated they had at least three of these symptoms.

According to the results, all comparisons favored the Alimta+cisplatin arm versus the cisplatin-alone arm. In particular, patients reported that the extent of their pain, shortness of breath and cough was significantly better by week 12, or after four cycles of treatment with Alimta+cisplatin, compared to cisplatin alone. These improvements persisted through two other measured periods of time: week 15 (five cycles of treatment) and week 18 (six cycles of treatment). In this study, evaluation was completed at the end of week 18.

Patients' level of fatigue was significantly better by week 15 and lasted through week 18 (the end of the evaluation period). In sum, according to the researchers, by week 18, significantly more patients on the Alimta+cisplatin arm reported better quality of life compared to patients on cisplatin only. As with the findings on survival, these results reached the level of statistical significance (p= 0.012).

The most common side effect of Alimta+cisplatin therapy observed in this 448-patient study was a decrease in white blood cell counts (technically known as neutropenia), but the rate of serious infection was very low. The severity of neutropenia, as well as other side effects, including diarrhea and painful mouth ulcers, was significantly ameliorated by folic acid and vitamin B12 supplementation.

In the United States, Alimta is in the process of a rolling submission to the U.S. Food and Drug Administration (FDA) for use, with cisplatin, in the treatment of malignant pleural mesothelioma. In the meantime, in cooperation with the FDA, Lilly has provided Alimta free of charge to more than 600 patients with mesothelioma as part of an expanded access, or compassionate use, program. Similar programs are underway in other countries around the world as well. "This is simply the right thing to do," said Paoletti. "Until now, patients could really only look forward to a steady downhill course. Now, patients with malignant pleural mesothelioma have access to a treatment that offers a chance of having an impact on the course of their disease."

For more information about the expanded access program in the U.S., physicians may call 1-866-347-9503 (patients are asked to work through their physicians). Additionally, information can be found at www.ClinicalTrials.gov, a service of the National Institutes of Health. Key Word: mesothelioma. For information on expanded access programs involving Alimta and mesothelioma in additional countries, patients are encouraged to have their doctors send an email to Alimta@Lilly.com.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs

Lilly's drug for cancer 'exciting'

Indianapolis Star, IN - Jun 2, 2003

The experimental cancer drug Alimta worked so well in a study on lung cancer patients that Eli Lilly and Co. said Monday it will ask for federal approval to market the drug for that use, too.

Tapping the large market for lung cancer, which is diagnosed in 175,000 Americans every year, could vastly expand sales possibilities for Alimta. Up to now, Lilly had planned to target the drug only for mesothelioma, a rare cancer of the lung lining caused by asbestos exposure.

Alimta's effectiveness in treating the most common form of lung cancer could amount to "a huge benefit for patients and also for health care," said Dr. Paolo Paoletti, Lilly vice president of clinical research for oncology.

The Indianapolis drug maker revealed the new Alimta findings at the annual meeting of the American Society of Clinical Oncology in Chicago.

In the Lilly-sponsored study, Alimta proved as effective as Taxotere as a second-line treatment for non-small cell lung cancer. Taxotere, made by Aventis and sold since 1999, is the only federally approved drug to treat recurring cases of the common lung cancer in patients who've been unsuccessfully treated with first-line chemotherapy.

Survival was largely the same, at about eight months, for both Taxotere and Alimta patients.

Not only did Alimta match Taxotere in effectiveness, Alimta caused far fewer side effects among the 571 lung cancer patients studied.

Only 5 percent of patients taking Alimta saw a dangerous drop in white blood cells, compared with 40 percent of patients on Taxotere. A low white blood cell count can lead to fever or infection.

In addition, only 10 percent of patients given Alimta suffered serious drug-related adverse events, compared with 24 percent of Taxotere patients.

Fewer side effects should make Alimta a more useful drug for patients and doctors, said Dr. Nasser Hanna, an assistant professor of medicine at Indiana University School of Medicine, who presented the study findings.

Alimta sales geared mainly toward mesothelioma could hit $157 million by 2006, said the investment firm Friedman Billings Ramsey & Co. But last year, the investment firm Lehman Bros. forecast peak annual sales for Alimta of $1 billion, assuming it's used against multiple cancers, a dollar figure that would put Alimta among Lilly's top-selling drugs.

Lung cancer in its most common form typically kills its victims within eight months of diagnosis, so avoiding serious drug-induced side effects during that time is important for patients and their families, Hanna said.

In the study, Alimta was supplemented with vitamin B-12 and folic acid, but Hanna said the vitamins alone didn't account for the fewer side effects.

About a half-dozen drugs are approved as first-line treatments for common lung cancer. They include another Lilly product, Gemzar, and the well-known Taxol, from Bristol-Myers Squibb Co.

But those products often only slow down lung cancer's spread, so new treatments are needed, Hanna said. "This opponent we face is so difficult. Whenever we get another drug, that's exciting."

Lilly will use the new study to ask the Food and Drug Administration to approve Alimta for common lung cancer, as well, which would significantly expand the drug's market.

"That would be my dream. But it's in the hands of the FDA," Paoletti said.

In earlier studies, Alimta proved its worth in lengthening the lives of patients stricken with mesothelioma, which is diagnosed in 10,000 people worldwide annually. No drugs are currently approved in the United States to treat the deadly cancer caused by airborne asbestos. Lilly expects to receive FDA approval late this year or early 2004 to sell Alimta for mesothelioma.

Lilly is filing for approval at a favorable time for what would be its second cancer drug. Under pressure to get new cancer treatments to market, the FDA has speeded up its approval process, approving some drugs even before the last of three stages of human testing is complete.

Alimta came out of the Princeton University labs of Edward C. Taylor, an emeritus professor of organic chemistry. A synthetic compound, Alimta works against cancer by interfering with the way natural folic acid is converted into enzyme co-factors necessary for cancer cell division.

Alimta is given intravenously. In the lung cancer study, patients underwent a 10-minute infusion every three weeks.

Lilly has FDA approval to supply Alimta for free on a compassionate-use basis to more than 600 mesothelioma patients. Lilly makes the drug in Europe