Mesothelioma Cancer

NEWTON, Mass.–(BUSINESS WIRE)–Novelos Therapeutics, Inc. (OTCBB: NVLT – News), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the primary endpoint of improvement in overall survival was not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy. Detailed trial results are expected to be presented via appropriate scientific venue later this year.

This randomized, controlled, open-label Phase 3 trial, conducted under a Special Protocol Assessment (SPA) and Fast Track designation, had enrolled 903 patients with Stage IIIb/IV NSCLC, which includes all histological subtypes. The trial, conducted across approximately 100 clinical sites in 12 countries, evaluated NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial was improvement in overall survival. Enrollment commenced in November 2006, target enrollment was achieved in March 2008, and the 725 event (patient death) was announced in early January 2010. According to the trial’s Statistical Analysis Plan (SAP), a total of 725 events were required to detect a 25% improvement (12.5 months versus 10 months) in overall median survival (hazard ratio of 0.8) with 85% power and a two-sided significance level of 0.05. No interim analysis was performed.

“We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint,” said Harry Palmin, President and CEO of Novelos. “We were hopeful of a positive outcome based on our statistical model simulations and stated assumptions. In retrospect, it appears our simulations were inaccurate due to trial data deviating from our statistical model, the impact of censoring patterns, and control arm survival exceeding our expectations based on historical precedents. We will conduct a thorough analysis of all the data, and expect to present detailed Phase 3 lung cancer trial results later this year. Meanwhile, we are scheduled to present new NOV-002 preclinical data at the AACR Annual Meeting in April 2010, and we are on track for results from a NOV-002 Phase 2 breast cancer trial in 3Q 2010. We are also on track to initiate a Phase 2 hepatitis C trial shortly, with our second compound NOV-205.”…. Read more…

Adverse events in childhood have been linked to an increase in the likelihood of developing lung cancer in later life. Researchers writing in the open access journal BMC Public Health describe how the link is partly explained by raised rates of cigarette smoking in victims of childhood trauma, but note that other factors may also be to blame.

David Brown and Robert Anda, from the Centers for Disease Control and Prevention, Atlanta, USA, worked with a team of researchers to study the effects of abuse (emotional, physical, sexual), witnessing domestic violence, parental separation, or growing up in a household where people were mentally ill, substance abusers, or sent to prison. He said, “Adverse childhood experiences were associated with an increased risk of lung cancer, particularly premature death from lung cancer. Although smoking behaviours, including early smoking initiation and heavy smoking, account for the greater part of this risk, other mechanisms or pathophysiologic pathways may be involved”.

Adverse event information was collected from 17,337 people between 1995 and 1997. Brown and his colleagues followed up on the medical records of these same people to study lung cancer rates in 2005. According to Brown, “Compared to those who claimed no childhood trauma, people who experienced six or more traumas were about three times more likely to have lung cancer, identified either through hospitalization records or mortality records. Of the people who developed, or died of, lung cancer, those with six or more adverse events in childhood were roughly 13 years younger at presentation than those with none. People who had experienced more adverse events in childhood showed more smoking behaviors”.

The central message of this study is that our children can be faced with a terrible burden of stressors. These stressors are associated with harmful behaviours, such as smoking, that may lead the development of diseases like lung cancer and perhaps death at younger ages. Reducing the burden of adverse childhood experiences should therefore be considered in health and social programs as a means of primary prevention of lung cancer and other smoking-related diseases.

Source: BioMed Central Limited

“We hope this mutation signature will be able to define patients with these tumor types who will then respond to EGFR inhibition,” said Pierre Saintigny, M.D., Ph.D., a research scientist at the University of Texas M. D. Anderson Cancer Center.

Data presented at the AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer have immediate clinical implications. The EGFR-mutation signature will be evaluated as a predictor of response in the BATTLE (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination) I trial, which will be presented later this year….. Read more…

A short spot created for ‘A Breathe Of Fresh Air’ a Lung Cancer fundraiser in Montreal, Canada.

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(Washington, January 7 : A new study has shown that the volcanic eruptions thought responsible for Earth’s largest mass extinction 250 million years ago has been linked to unusually high rates of lung cancer in a particular area of China.)

The study, by scientist David Large and colleagues, note that parts of China’s Xuan Wei County in Yunnan Province have the world’s highest incidence of lung cancer in nonsmoking women — 20 times higher than the rest of China. ….. Read more…

PHILADELPHIA — Children exposed to secondhand cigarette smoke have an increased risk of developing lung cancer in adulthood, even if they never smoked.

Results of this study are published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research, as part of a special tobacco focus in the December issue.

This year alone, more than 219,000 Americans will be diagnosed with lung cancer; more than 159,000 will die from it and some of those may be people who have never smoked. Studies to date have shown that exposure to secondhand smoke in adulthood has detrimental health effects, but data are limited on one’s risk of developing lung cancer when exposed as a child.

What makes this study different from previous research is that it was conducted in two independent cohorts and included a molecular analysis of gene variants of innate immunity — the mannose binding lection-2 gene, or MBL2 gene. The MBL2 gene is known to affect susceptibility to respiratory diseases….. Read more…