Category Archives: Transhuman News

Sept. 28, 2014, 12:15 a.m.

This month the Federal Court decided that private companies have the right to control human genes in an important test case. A sensible win for private investment in research or a scary corporatisation of our shared genes? Jane Lyons sequences the debate.

This month the Federal Court decided that private companies have the right to control human genes in an important test case. A sensible win for private investment in research or a scary corporatisation of our shared genes? Jane Lyons sequences the debate.

Q. What was the "breast-cancer gene" court case about?

A.Social justice law firm Maurice Blackburn, which launched the court case in 2010, has gone two rounds with US biotech behemoth Myriad Genetics to invalidate its Australian patent for a mutation of the BRCA1 gene. This gives the patent holder a monopoly over the breast and ovarian cancer gene itself as well as its diagnostic test.

It lost the first Federal Court round last year and copped another beating in the appeal this month. But while this case was ostensibly about one patent, both sides have had their eyes firmly on the bigger prize.

For Maurice Blackburn, the BRCA1 case tests the controversial practice of gene patenting, which has been happening in Australia since the 1990s and has never been legally challenged here.

The lawyers arguethe practiceis based on an invalid premise:that isolating a gene from the body makes it an "artificial state of affairs" and therefore an invention (which can be protected by a patent), rather than a discovery (which cannot).

Their problem with these patents? Monopolies, higher test costs for patients, the stifling of genetic research and the questionable ethics of a company owning the rights to our genes.

Over in the other corner, Myriad has been fighting not only for its future but also for the biotech industry, which has anxiously watched the outcome. Myriad's 20-year BRCA1 patent expires next August, but it has more gene-patent irons in the fire. It argues that the isolation and chemical modification of BRCA1 needed to analyse it in the laboratory makes it an innovation worthy of patent protection.

See more here:
Explainer: cancer gene legal case a win for corporate medicine or common sense?

Pfizer Inc. (PFE)s Xalkori for advanced lung cancer shrunk tumors in those with a rare genetic mutation, according to a study that may provide the first targeted treatment for these patients.

Xalkori reduced the size of tumors in 36 of 50 patients in the study while halting tumor growth in another nine, according to company-funded research released today at the European Society for Medical Oncology meeting in Madrid and online in the New England Journal of Medicine.

About 15,000 people, or 1 percent of the estimated 1.5 million annual new cases of non-small-cell lung cancer, have an abnormality to the ROS1 gene, according to New York-based Pfizer. Todays findings also showed that Xalkori was effective for about 18 months in patients, longer than the average eight to 12 months seen for some other targeted treatments, said Alice Shaw, a lead study author.

Were seeing much longer durations of remissions, Shaw, an associate professor of medicine at Harvard Medical School and Massachusetts General Hospital in Boston, said in a telephone interview. This points to being a very good target in lung cancer and this drug being a very effective targeted therapy for these patients.

Xalkori helps shut off the ROS1 gene that is causing cancer tumors to grow, she said. It was approved in 2011 to treat non-small-cell lung cancers in patients with mutations to the ALK gene, which has structural similarities to the ROS1 gene. The National Comprehensive Cancer Network, an alliance of 25 cancer centers, already recommends that doctors use Xalkori in patients who have this gene defect.

Pfizer continues to support clinical research of Xalkori in patients with ROS1 rearrangements to better understand the compounds activity in this population, Sally Beatty, a company spokeswoman, said in an e-mail.

The cancer drug generated $282 million in 2013 sales, according to data compiled by Bloomberg. The drug may produce revenue of more than $812 million in 2017, according to the average of five analysts estimates.

Patients with a mutation to the ROS1 gene are often younger and usually arent smokers, Shaw said.

Todays study is an expansion of the original Phase 1 clinical trial of Xalkori in patients with the ALK gene mutation. Researchers enrolled 50 patients who were ROS1 positive starting in late 2010 through August 2013. Those in the study received Xalkori two times daily.

By the end of the trial, half of the patients were still getting Xalkori and had no signs of their tumors growing, the authors said.

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Pfizers Lung Cancer Drug Helps Patients With Gene Defect