The clinical trial involves 60 patients at 12 centers in Australia.It is a single arm, unblinded study for patients with mesothelioma who have progressed on platinum/pemetrexed chemotherapy. BNC105 will be administered on days 1 and 8 of 21-day cycles. Treatment will continue until disease progression. The primary objective is to determine the tumor response rate.

Principal investigator for the trial is Dr. Anna Nowak, professor at the Faculty of Medicine, University of Western Australia and consultant medical oncologist at Sir Charles Gairdner Hospital. According to information on the company’s web site, Bionomics has already commenced Phase II testing of the anti-cancer properties of BNC105 in renal cancer in the United States. The commencement of this Phase II trial follows a successful BNC105 Phase I clinical trial in patients with advanced cancers at the Peter MacCallum Cancer Centre, the Western Hospital, Austin Health and the Royal Melbourne Hospital.

Dr. Nowak says, “Mesothelioma remains a substantial problem in Australia and other parts of the world. An early clinical trial of BNC105 suggested some promise in mesothelioma. This Phase II trial will provide hope and an opportunity to participate in a research study for people with mesothelioma who do not have other options for treatment.”

Dr. Deborah Rathjen, CEO and Managing Director of Bionomics, says the company expects to report interim results of this study in mesothelioma patients in early 2011.

In 2005, Bionomics reports there were 597 new cases of mesothelioma diagnosed in Australia and in 2006 there were 486 deaths attributed to mesothelioma.

More information about the clinical trial is available online. Inquiries may be directed to:

Bionomics Limited
Dr Deborah Rathjen
CEO & Managing Director
+61 8 8354 6101 / 0418 160 425
drathjen@bionomics.com.au

Monsoon Communications
Rudi Michelson
+61 3 9620 3333

SOURCE: myMeso › Bionomics begins Phase II clinical trial of mesothelioma med in Australia

Debbie provided a link to a story published in November 2009 by ABC News that outlines the work of specialists at Austin Health Centre in Victoria. The treatment, spearheaded by Dr. Malcolm Feigen, a radiation oncologist at the Centre, uses high doses of radiotherapy, concentrated on specific areas of the lining of the lungs to target mesothelioma tumors.

According to the ABC report, 13 patients participated in a pilot program to test this new targeted radiotherapy treatment. Most had some surgery prior to the radiotherapy treatment, and some also had chemotherapy before or after the treatment, although Dr. Feigen believes the patients showed the most benefit primarily as a result of the radiotherapy regimen.

Participants in the U.S. clinical trial at the Mesothelioma Center receive a multi-modality therapy that incorporates surgery, chemotherapy and radiation therapy in combination.

Listen to the interview with Dr. Feigen about the Australian research, which was broadcast on ABC’s AM morning current affairs program.

SOURCE: myMeso › Australian doctor researching radiotherapy for treatment of pleural mesothelioma

According to the Herald report, this Phase II study comes on the heels of a successful Phase I clinical trial of Bionomics’ BNC105, which was administered to patients with advanced cancers at Peter MacCallum Cancer Centre, the Western Hospital, Austin Health and the Royal Melbourne Hospital.

Bionomics has contacted the Australasian Lung Cancer Trials Group (ALTG) and the NHMRC Clinical Trials Centre (CTC) to conduct the clinical trial. No date has yet been set for the trial start.

BNC105 is described as “a novel anti-cancer agent which is both a vascular disrupting agent (VDA) and an inhibitor of cancer cell proliferation.”

For more information about the Phase II clinical trial of BNC105 for mesothelioma patients in Australia, email clinicaltrials@bionomics.com.au. You can also find out more information about ongoing clinical trials in Australia and New Zealand by visiting the Australian New Zealand Clinical Trials Registry (ANZCTR) at www.anzctr.org.au.

SOURCE: myMeso › Bionomics set to begin Phase II clinical trial following initial success of cancer drug

The exhibit debuted at the Australian Centre for Photography on July 17 (ended Aug. 22) and will next be featured at Latrobe Regional Gallery beginning Sept. 5 and running through October 4.

According to a World News Australia report about the project, Ireland was inspired with the idea for the exhibit after learning about mesothelioma in his mid-teens when a friend’s father passed away from the disease. He feels that the fact that mesothelioma is currently incurable adds to the poignancy of the loss, and says he hopes that by sharing these ladies’ stories, he can help raise awareness about the dangers of exposure to asbestos.

The World News quotes Ireland as saying, “…these ladies have gone through pain, they deserve to be heard and other people should avoid the same process.”

More information about the exhibit, including its striking images, can be found at Chris Ireland’s web site.

The Latrobe Regional Gallery is located at 138 Commercial Road, Morwell VIC. The exhibit will be open Monday-Friday from 10 a.m.-5 p.m. and Saturday and Sunday from 11 a.m.-4 p.m.

SOURCE: myMeso › Australian photographer captures emotions of meso widows in touching exhibit

According to the research summary, the objective of the study was to evaluate the perioperative and long-term outcomes associated with extrapleural pneumonectomy for patients with malignant pleural mesothelioma. Pleural mesothelioma affects the lining of the chest cavity and lungs. Other forms of mesothelioma include pericardial, which affects the lining of the heart and is extremely rare; and peritoneal, which affects the lining of the abdomen. Mesothelioma is atributed almost exclusively to asbestos exposure.

According to the Multimedia Manual of Cardiothoracic Surgery, extrapleural pneumonectomy was introduced in the 1940s for the treatment of extensive infections of the lung and pleural space. Over the past 20 years, the extrapleural pneumonectomy technique has been modified and applied to the treatment of locally advanced malignant pleural mesothelioma, achieving substantial reductions in mortality. The surgery involves the removal of the lung with visceral and parietal pleurae, pericardium and diaphragm.

Researchers selected 70 patients between October 1994 and April 2008 to undergo the procedure. Prognostic factors included age, gender, side of disease, asbestos exposure, histology, positron emission tomography, date of surgery, neoadjuvant chemotherapy, completeness of cytoreduction, lymph node involvement, peioperative morbidity, adjuvant radiotherapy and pemetrexed-based chemotherapy.

The mean age of patients was 55 years. The median survival was 20 months, with a 3-year survival of 30 percent. Analyses showed improved survival for patients with asbestos exposure, negative lymph node involvement, and receipt of adjuvant radiation or postoperative pemetrexed-based chemotherapy.

The study was conducted by physicians from the University of Sydney, Department of Cardiothoracic Surgery, Royal Prince Alfred Hospital; The Baird Institute for Applied Heart and Lung Surgical; Department of Medical Oncology, Sydney Cancer Center, Royal Prince Alfred Hospital; and Department of Radiation Oncology, Sydney Cancer Center, Royal Prince Alfred Hospital; all in Sydney, Australia.

SOURCE: myMeso › Study supports extrapleural pneumonectomy to treat select mesothelioma patients

James Hardie was one of Australia’s largest manufacturers of asbestos building products, and was alleged to have known the dangers of asbestos for decades.

The current proceedings came about as a result of ASIC’s investigation of matters identified by the Special Commission of Inquiry into the Medical Research and Compensation Foundation. James Hardie established the foundation, which was intended to compensate families who lost loved ones to asbestos disease, in 2001. The inquiry into the MRCF was established in 2004, and the commission found that James Hardie industries deliberately underfunded the victims’ compensation fund

According to a report by Nonee Walsh of ABC News, who has been following the story since 2003, James Hardie has spent about $25 million so far fighting the ASIC’s case, while asbestos victims and their families have been simultaneously negotiating for new funding for the foundation. Payments to the new asbestos compensation foundation are currently suspended.

Walsh also noted that Australia has one of the highest rates of asbestos disease in the world, including asbestos-caused lung cancer, mesothelioma. In 2003, when the sale of all asbestos products was finally banned in Australia, the National Occupational Health and Safety Commission went on record as saying there is no known safe level of asbestos exposure.

The only known cause of mesothelioma is asbestos exposure, and there is currently no known cure. Mesothelioma most often affects the lining of the chest cavity and lungs, but also may affect the lining of the abdomen or, more rarely, the heart. Asbestos exposure also causes a variety of other diseases, including asbestos, a severe scarring of the lungs.

It is estimated that the levels of asbestos disease will not peak in Australia until 2020, when it is expected that there will be 13,000 cases of mesothelioma and up to 40,000 cases of other asbestos-related lung cancer and disease.

The New South Wales Supreme Court imposed financial penalties totaling $750,000,  and said the company directors and executives named in the case will be barred from serving other boards of directors for between 5 and 15 years.

According to the ASIC, the James Hardie decision underlines the responsibility of companies to assess and check the veracity of statements make to the market. ASIC Chairman Tony D’Aloisio said, “The decision is another important step in improving corporate governance in Australia and that improvement will add confidence to the integrity of our markets.”

The matter will return to the Court on August 27, at which time the Court will make orders reflecting the penalties. The defendants will then have 28 days to appeal the findings.

SOURCE: myMeso › James Hardie executives handed penalties in asbestos compensation fund case

According to a report in the Herald Sun, the Bernie Banton Centre will be the world’s largest stand-alone asbestos diseases and research institute.

Banton was a leader in the campaign to raise awareness of mesothelioma and other asbestos-related diseases in Australia, and a tireless fighter to obtain compensation for workers exposed to asbestos on the job.

The Hills News cites Prime Minister Rudd as saying the death rate among Australians as a result of mesothelioma is increasing, with an estimated 13,000 diagnosed cases expected by 2020. Rudd told the News, “Next year, around 750 Australians will be diagnosed with asbestos-related diseases. These are bad figures.”

Bernie Banton passed away as a result of mesothelioma in May 2008, at age 61.

Photo by Andrew Quilty, Sydney Morning Herald

SOURCE: myMeso › Australian asbestos fighter Banton honored

It is believed that Anita was exposed to asbestos more than 30 years ago, when she watched her father dismantle a shed covered with asbestos.

Even before her cancer diagnosis, Anita had struggled to have a baby, undergoing in vitro fertilization (IVF) but receiving only about a 1 percent chance to conceive naturally. After the diagnosis of mesothelioma, she had to stop IVF and relinquished her dream of motherhood. After radical surgery and six months of chemotherapy, the notion that she might become pregnant never entered her mind, she writes in her blog, anitalive.com.

It seems Anita is destined to beat the odds in life.

Her oncologist, Ian Haines, who practices at Cabrini Hospital, says Anita is in remission, according to a story in the The Age. He says the news of her pregnancy was “a surprise, to say the least,” and that after all her cancer treatments for Anita “…to become pregnant naturally and then give birth to this perfect baby was an absolute miracle.”

As of Christmas Day, the couple had not yet named the baby.

Anita’s story was recently featured on the news in Australia. Watch it here:

What a joy and an inspiration! God bless you, Anita, and your family!

SOURCE: myMeso › Meso survivor delivers ‘miracle baby’ in time for Christmas

However, Harrington says he is teaching his last 12-month course at the school, which will be completed at the end of this year. He is discontinuing his role as an instructor after being diagnosed with mesothelioma, the News reports. He says his time spent as an instructor was a “career high.” Mr. Harrington is 57 years old. The news report does not elaborate on his current health or future treatment choices that led him to the decision to stop teaching.

Harrington currently serves as Director for the school, a position he has held since 1992. His biographical information says he trained at the Canberra School of Art under George Ingham and has worked as a studio furniture maker and a commercial cabinetmaker. His work is exhibited regularly in Australia and is represented extensively in private collections.

The Southern Highlands is positioned half-way between Sydney and Canberra on the main southern corridor. Situated 90 minutes from each of these major cities the shire has a population of nearly 37,000 and is maintaining a steady growth rate. The shire consists of several small villages that surround the major retail centres of Bowral, Mittagong and Moss Vale.

SOURCE: myMeso › Australia losing expert craftsman to mesothelioma

A British record label, Candid Records, agreed to release the CD, and Keith recruited a number of musicians to fill in the gaps on the tracks to finally see the project through. The CD was called Free Time, a name initally selected because the original tracks recorded in 1973-74 were done during a recording studio’s down time, when a friend who worked there was able to lend Keith and Gary the space. But the liner notes, penned by Keith to tell the story of how the recording came together, tend to more solemn reflection.

“Then suddenly completion is in front of you and there is no free time anymore,” he writes, and it’s easy to see the dual implication of a completed project and a completed life.

Keith passed away just as the CD was pressed, and it is unlikely he saw it in its final form.

The special edition release of Free Time is available only through the Candid Records web site, and is shipped from the UK. Cost is £9.99 plus shipping, which totals around $24 U.S. once you figure in the exchange rate. But all proceeds from the sales will go to Bart’s Mesothelioma Research, an organization in Britain dedicated to the treatment of mesothelioma.

I received my CD yesterday. Full of free-spirited modern jazz tunes highlighting Keith on saxophone, the CD is joyful and jamming and sometimes poignant. It is perhaps hardest to comprehend when mesothelioma steals the breath of those who create music, before it steals their life.

SOURCE: myMeso › jazz CD a tribute to artist affected by meso

Shadwick, who passed away from mesothelioma on July 28, 2008, was a respected journalist and author whose background as a jazz and rock musician in the 1970s led to a career focus on music and musicians. His credits include books on noted jazz musician Bill Evans, as well as Jimi Hendrix and Led Zeppelin. He also authored The Jazz & Blues Encyclopedia, the Guinness Guide to Classical Composers, and edited The Gramophone Good CD Guide. Additionally, he was a regular contributor to publications including Jazzwise magazine, The Independent and The Daily Mail.

According to an article published on All About Jazz.com, during his early 20s, Shadwick was a jazz and jazz/rock musician, playing saxophone, flute and piano. He was a founding member of the Sydney, Australia-based group, Sun, which released one self-titled album in 1972 before splitting up. In 1973 and 1974, the story reports, Shadwick and fellow Sun member, drummer Gary Norwell, recorded some jazz tracks with fellow musicians Justin McCoy and Robert Luckey when local Point Five Studio offered them use of its facility during a free downtime.

As a nod to their luck in securing the studio, the musicians named the album Free Time, but it was not completed or released. Shadwick held onto the tapes, and revived work on the recording in 1984, with guitarist Billy Jenkins, and again in 2005, with guitarist Mike Wollenberg.

All About Jazz notes that Shadwick was motivated to finish the album in 2005, when he was diagnosed with mesothelioma, and completed the project in 2007, although it is unlikely that he lived long enough to see its official pressing, which was delivered to his home right around the time of his death. The album was produced and released by Candid Records in the UK.

The Special Edition of the Free Time CD is available in limited release through the Candid Records web site, with all proceeds benefitting Bart’s Mesothelioma Research. Cost is £9.99 plus shipping, which totals around $24 U.S.

SOURCE: myMeso › Shadwick CD benefits mesothelioma research

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.

SOURCE: myMeso › ONCONASE expands to Israel as meso concerns there grow

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 Australia 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 hope 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.”

SOURCE: myMeso › Quintessence continues with mesothelioma drug

Results of the company’s late-stage trial of the drug showed that Onconase did not achieve significantly higher survival rates among patients with unresectable malignant mesothelioma when given in combination with doxorubicin, another cancer chemotherapy drug.

According to a report on Pharmaceutical Online, the preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving Onconase plus doxorubicin. The median survival time (MST) for evaluable patients who received Onconase plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

However, there is a silver lining to the study. Pharmaceutical Online reports those patients who failed a previous chemotherapy regimen who received Onconase plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin, which is considered a statistically significant result.

Reuters reports as a result of this secondary finding, Alfacell will now submit a marketing application to the Food and Drug Administration for use of the drug on those patients, with hopes to have it approved by the end of the year.

SOURCE: myMeso › Onconase fails in primary late-stage trial

According to the report, the “first wave” of mesothelioma victims were those who mined asbestos, and the second wave affected people who worked with asbestos in factories or manufacturing industries. The next wave, they say, is affecting people who work with asbestos materials, like construction workers.

In addition to mesothelioma, exposure to asbestos, which has been used in building materials in Australia for decades, also causes asbestosis and asbestos-related lung cancers.

Asbestos Diseases Foundation of Australia president Barry Robson is working with government officials for a national approach to education, treatment and compensation for asbestos-related diseases.

SOURCE: myMeso › Australia braces for new wave of mesothelioma cases

The Australian study, conducted by cancer research specialist Professor Julian Peto, was based on research into the lifetime occupations of 600 mesothelioma patients. Its findings were reported by the web site news.theage.com.au yesterday.

Peto predicts 30,000 Australians will die from mesothelioma between 2000 and 2050. He says the cause is exposure to both crocidolite asbestos (blue asbestos) and amosite (brown asbestos), which was used in building products in Australia and Britain until the 1980s.

According to the story on theage.com.au, Peto’s research reveals that Australia and the UK currently have the highest rates of mesothelioma in the world, with an estimated 600 cases per year in Australia and 2,000 in Britain, with numbers still rising.

Because I write this blog in the United States, I don’t talk as much about the looming global disaster asbestos poses. But it’s frightening, and it’s sickening, to see the effects of asbestos exposure just surfacing in communities around the world. I am afraid the coming suffering is unimaginable.

SOURCE: myMeso › Mesothelioma could kill 10% of Aussie carpenters

This week, I found a story that provides even more hope. It seems a Madison, Wisconsin-based biotech firm, Quintessence Bioscience, also has a promising mesothelioma drug in the works that operates along the same lines as ONCONASE, tagged QBI-139. The Quintessence drug is not yet in clinical trials.

Both drugs target RNA in cancer cells. They are therapeutic ribonucleases (RNases), which WTN News (Wisconsin Technology News) writer Steve Clark describes as “ubiquitous enzymes that destroy RNA.” He explains that researchers including the University of Wisconsin-Madison’s Ronald Raines, “discovered that RNases from non-human species sometimes are not regulated inside human cells and can cause cell death. Surprisingly, cancer cells are much more susceptible than normal cells to foreign RNases.”

The ONCONASE product is made from purified frog eggs. The Quintessence drug is 95 percent human, but still kills human cancer cells, Clark reports. Both drugs can kill a wide range of different human cancer types, he says, so its application has broad potential. The ONCONASE clinical trial data is from patients with malignant mesothelioma.

Clark reports that Quintessence is optimistic about its QBI-139 surpassing the positive results of ONCONASE. He says that frog-derived ONCONASE has been shown to cause allergic reactions in some patients, which would be mitigated in the 95 percent human-gene QBI-139. Additionally, he reports QBI-139 is less toxic than ONCONASE, which will allow it to be better tolerated by some patients in larger doses.

Currently, Clark reports, QBI-139 is being produced for use in a Phase I clinical trial, which is set to begin this summer and end sometime in 2009. It is anticipated that the trial will be held at the University of Wisconsin Carbone Cancer Center.

Read the full article at WTN News.

Steve Clark, Ph.D., is a former professor and medical researcher at the University of Wisconsin School of Medicine and Public Health, and is currently a freelance writer and consultant on biotechnology issues.

SOURCE: myMeso › New mesothelioma drug being developed

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 Australia.

SOURCE: myMeso › ONCONASE on fast track for Meso treatment

The vascular disrupting agent (VDA) is under investigation in treating specific types of cancer with high unmet medical need and poor prognosis. Mesothelioma is included in the study, and is entering Phase II clinical trials.

The company reports favorable findings in mesothelioma patients in a Phase I trial. Based on these results, Cytopia is beginning feasibility analysis for a Phase II study in mesothelioma patients who have failed the currently approved drug, Alimta (pemetrexed).

The single-arm study will include 20-30 patients in Australia, the United States and Asia. The company hopes that activity in second-line mesothelioma could lead to expedited drug approval and a fast to-market strategy for the compound in this cancer indication. They expect to file reports on this study in the third quarter of 2008.

Cytopia, Ltd., is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer.

SOURCE: myMeso › Australian company advances anti-cancer drug