Don’t Do It Just Because Angelina Jolie Did It

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The nonprofit ECRI Institute has released a BRCA testing information guide for patients interested in learning more about the genetic risk of hereditary breast and ovarian cancer.

The guide comes in response to the growing concern and questions among women about the information their genes contain about the risk for cancer, after actress Angelina Jolie wrote an op-ed piece discussing her decision to get a double mastectomy as a result of carrying a BRCA1 mutation associated with heightened risk of hereditary breast and ovarian cancer. There are reports that Jolie’s highly publicized and controversial decision has caused a spike among women asking their physicians for BRCA testing.

“People can get caught up in the headlines, which can lead to quick, uninformed decisions,” says Vivian Coates, VP of information services and health technology assessment at ECRI Institute, in a statement. “Many women may find that after talking to their physicians about their risks for the BRCA gene mutation, the best course of action may actually be to do nothing.”

Indeed, the US Preventative Services Task Force’s 2005 guidelines recommend that women with a history of breast and ovarian cancer be referred for genetic counseling and be evaluated for BRCA testing. For those without a family history of cancer, the USPSTF does not recommend counseling or BRCA testing.

In addition to information about who should be tested, ECRI’s guide also includes information on Myriad’s BRACAnalysis, highlighting it as the “currently available test.” ECRI characterizes BRACAnalysis as “highly accurate” and reimbursed by most insurance companies if the woman meets certain criteria for testing. The institute also mentions that other labs have indicated they will offer testing for BRCA mutations as the US Supreme Court recently ruled that patents on isolated gene sequences are invalid, but ECRI does not offer any details about these new tests.

Do you wish to know more? – BRCA Gene Mutation Consumer Guide

FDA Approves Dako Assays as CDx for Genentech Breast Cancer Drug

Dako today said that the US Food and Drug Administration has approved two assays for use as companion diagnostics for a Genentech drug targeting HER2-positive metastatic breast cancer.

FDA simultaneously approved Dako’s HercepTest and HER2 IQFISH pharmDx assays and Genentech’s drug Kadcyla (ado-trastuzumab emtansine).

Kadcyla is for patients with HER2-positive metastatic breast cancer who have been previously treated with Genentech’s Herceptin (trastuzumab) and a taxane chemotherapy.

Dako, an Agilent company, and Genentech, a Roche company, have been collaborating on the development of companion diagnostics for Genentech’s drugs for a few years. In May 2012 the two firms inked a pact to collaborate on the FDA submission of Dako’s assays for Kadcyla.

A month later the HercepTest and HER2 FISH pharmDx were approved by FDA as companion diagnostics for Genentech’s breast cancer drug Perjeta (pertuzumab). In late 2011, FDA gave the thumbs up to Dako’s HER2 CISH pharmDx kit as a companion diagnostic for Herceptin in the treatment of breast cancer patients.

And in 2010, the agency approved the use of HercepTest and HER2 FISH pharmDx to help guide treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma with Herceptin. cancer
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Agilent to Acquire Dako for $2.2 Billion Acquisition is Next Step in Agilent’s Growing Role in Clinical Diagnostics

Dako is one of the leading global providers of cancer diagnostics tools.

–Acquisition will strategically complement Agilent’s research technologies and will accelerate growth in rapidly expanding segments of diagnostic markets.

–Significantly increases base of recurring revenues.

–All-cash deal is largest in Agilent’s history.

Expected to be immediately accretive to Agilent earnings on a non-GAAP basis.

Agilent Technologies Inc. and EQT, the Sweden-based private equity group, today announced the execution of a definitive agreement for Agilent to acquire Dako, the Denmark-based cancer diagnostic company. The $2.2 billion acquisition (on a debt-free basis) is the largest in Agilent’s history.

Dako’s products are sold in more than 100 countries, and in 2010 its annual revenue was approximately $340 million (USD). The company employs more than 1,000 people, primarily in Denmark, in Carpinteria, Calif., and other parts of the world. The acquisition is expected to close within the next 60 days, subject to the satisfaction of customary closing conditions.

Do you wish to know more?

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Protein drugs to facilitate easier treatment of cancer

Scientists have discovered a new physical form of proteins that could drastically improve treatments for cancer and other diseases, as well as overcome some of the largest challenges in therapeutics.

The protein formulation strategy, developed by researchers at The University of Texas at Austin, is unprecedented and offers a new and universal approach to drug delivery one that could revolutionize treatment of cancer, arthritis and infectious disease.

“We believe this discovery of a new highly concentrated form of proteins – clusters of individual protein molecules – is a disruptive innovation that could transform how we fight diseases,” Keith P. Johnston, a chemical engineering professor and member of the National Academy Engineering, said.

“It required integration of challenging contributions in fundamental science and engineering from three of our chemical engineering research groups,” he said.

Johnston, Chemical Engineering Professor Thomas M. Truskett and Assistant Professor Jennifer Maynard have led the research.

“The real challenge in developing therapeutics is how do you deliver them to patients,” Maynard said.

Typically, protein biopharmaceuticals are administered intravenously at dilute concentrations in a hospital or clinic. Scientists and engineers have long tried to produce safe drugs at higher concentrations, so that a patient could self-inject the drugs at home, similar to an insulin shot.

However, doing so has been stymied by the fact that proteins, in high-concentration formulations, form aggregates that could be dangerous to patients and gels that cannot be injected.

The Cockrell School research team has introduced a new physical form of proteins, whereby proteins are packed into highly concentrated, nanometer-sized clusters that can pass through a needle into a patient to treat disease.

The novel composition avoids the pitfalls of previous attempts because drug proteins are clustered so densely that they don’t unfold or form dangerous aggregates.

“This general physical concept for forming highly concentrated, yet stable, protein dispersions is a major new direction in protein science,” Johnston said.

A key advance came in 2004, when Truskett predicted that protein-based drugs in solution would be stable if they could somehow be formulated at ultra-high concentrations. At that time, Johnston had nanoparticles of concentrated stable protein but didn’t know how to disperse them in an injectable form.

In 2009, the team formed protein nanoclusters in water simply by properly adjusting the pH (to lower protein charge) and adding sugar to crowd protein molecules together. Upon dilution or subcutaneous injection into a mouse the proteins separate back to individual stable molecules with biological activity.

Once injected, the protein in the bloodstream attacks targeted cells and tumors similarly as for protein delivered via IV therapy. To provide a roadmap for improving the design of nanoclusters, chemical engineering graduate students, Andrea Miller and Ameya Borwankar worked with Truskett and Johnston to develop a new thermodynamic theory.

Another breakthrough for the team came in 2009 when a chemical engineering senior, Brian Wilson, created a transparent dispersion of extremely concentrated protein, which was later found to be formed of nanoclusters.

The study has been published online in the ACS Nano journal.

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Protein drugs to facilitate easier treatment of cancer

Scientists have discovered a new physical form of proteins that could drastically improve treatments for cancer and other diseases, as well as overcome some of the largest challenges in therapeutics.

The protein formulation strategy, developed by researchers at The University of Texas at Austin, is unprecedented and offers a new and universal approach to drug delivery one that could revolutionize treatment of cancer, arthritis and infectious disease.

“We believe this discovery of a new highly concentrated form of proteins – clusters of individual protein molecules – is a disruptive innovation that could transform how we fight diseases,” Keith P. Johnston, a chemical engineering professor and member of the National Academy Engineering, said.

“It required integration of challenging contributions in fundamental science and engineering from three of our chemical engineering research groups,” he said.

Johnston, Chemical Engineering Professor Thomas M. Truskett and Assistant Professor Jennifer Maynard have led the research.

“The real challenge in developing therapeutics is how do you deliver them to patients,” Maynard said.

Typically, protein biopharmaceuticals are administered intravenously at dilute concentrations in a hospital or clinic. Scientists and engineers have long tried to produce safe drugs at higher concentrations, so that a patient could self-inject the drugs at home, similar to an insulin shot.

However, doing so has been stymied by the fact that proteins, in high-concentration formulations, form aggregates that could be dangerous to patients and gels that cannot be injected.

The Cockrell School research team has introduced a new physical form of proteins, whereby proteins are packed into highly concentrated, nanometer-sized clusters that can pass through a needle into a patient to treat disease.

The novel composition avoids the pitfalls of previous attempts because drug proteins are clustered so densely that they don’t unfold or form dangerous aggregates.

“This general physical concept for forming highly concentrated, yet stable, protein dispersions is a major new direction in protein science,” Johnston said.

A key advance came in 2004, when Truskett predicted that protein-based drugs in solution would be stable if they could somehow be formulated at ultra-high concentrations. At that time, Johnston had nanoparticles of concentrated stable protein but didn’t know how to disperse them in an injectable form.

In 2009, the team formed protein nanoclusters in water simply by properly adjusting the pH (to lower protein charge) and adding sugar to crowd protein molecules together. Upon dilution or subcutaneous injection into a mouse the proteins separate back to individual stable molecules with biological activity.

Once injected, the protein in the bloodstream attacks targeted cells and tumors similarly as for protein delivered via IV therapy. To provide a roadmap for improving the design of nanoclusters, chemical engineering graduate students, Andrea Miller and Ameya Borwankar worked with Truskett and Johnston to develop a new thermodynamic theory.

Another breakthrough for the team came in 2009 when a chemical engineering senior, Brian Wilson, created a transparent dispersion of extremely concentrated protein, which was later found to be formed of nanoclusters.

The study has been published online in the ACS Nano journal.

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The AVESTAGENOME Project™

Initiating sequencing of a set of 60 closely related human genomes to identify novel genetic information relevant to cancer, metabolic and neurological disorders. Through this project, Avesthagen intends to establish a direct link between genes, genetics and the disorders themselves. 

The study, led by Avesthagen, a life sciences company based in Bangalore, is being carried out in partnership with Genome Enterprise Limited, a subsidiary of The Genome Analysis Centre (TGAC) on the Norwich Research Park.. The TGAC team, specialists in DNA sequencing and bioinformatics, will use the SOLiD™ 4 next generation sequencing platform from Applied Biosystems, part of Life Technologies, to generate draft sequence, and will collaborate with the Avesthagen’s own bioinformatics experts to analyze and interpret the sequence data

It is known that many genes on the human chromosomes may be involved during the manifestation of the above disorders. However, the power of present technologies to link the causative genes to disorders is limited. Sequencing the 60 genomes for different disorders will be groundbreaking as analysis of the mammoth 10 terabytes of data generated will enable scientists to discover novel causative genes on the chromosomes which may be shown to be indicative of occurrence of cancer, metabolic and neurological disorders. Once completed there will be better understanding of the genetics underlying the diseases. The study will help in identifying new and better drugs, specific for the above-mentioned disorders. The discovery will lead to identifying bio molecules for the accurate prediction of the disease manifestation.

Avesthagen aims to facilitate predictive, preventive and personalized approach for diagnosis and treatment for cancer, metabolic and neurological disorders. Avesthagen has adopted a holistic approach applying state-of-the-art technology to not only come up with therapies, but go one step further in developing the most sensitive means of prediction and diagnosis. In its development program Avesthagen’s biopharmaceutical division also has a strong focus and drug portfolio pipeline on oncology and other above-mentioned disorders. Another major breakthrough by the company, in this field is the discovery of novel signature metabolites for Cancer, which is currently in the phase of clinical validation.

http://www.tgac.bbsrc.ac.uk/news/2010/100902Avestagenome.html
http://www.thehindubusinessline.in/2010/09/07/stories/2010090753650300.htm
http://www.genomeweb.com/sequencing/avestagenome-project-researchers-sequence-parsi-breast-cancer-genome
http://timesofindia.indiatimes.com/india/Genome-decoded-now-Parsi-ills-can-be-tackled/articleshow/7496919.cms

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The AVESTAGENOME Project™

Initiating sequencing of a set of 60 closely related human genomes to identify novel genetic information relevant to cancer, metabolic and neurological disorders. Through this project, Avesthagen intends to establish a direct link between genes, genetics and the disorders themselves. 

The study, led by Avesthagen, a life sciences company based in Bangalore, is being carried out in partnership with Genome Enterprise Limited, a subsidiary of The Genome Analysis Centre (TGAC) on the Norwich Research Park.. The TGAC team, specialists in DNA sequencing and bioinformatics, will use the SOLiD™ 4 next generation sequencing platform from Applied Biosystems, part of Life Technologies, to generate draft sequence, and will collaborate with the Avesthagen’s own bioinformatics experts to analyze and interpret the sequence data

It is known that many genes on the human chromosomes may be involved during the manifestation of the above disorders. However, the power of present technologies to link the causative genes to disorders is limited. Sequencing the 60 genomes for different disorders will be groundbreaking as analysis of the mammoth 10 terabytes of data generated will enable scientists to discover novel causative genes on the chromosomes which may be shown to be indicative of occurrence of cancer, metabolic and neurological disorders. Once completed there will be better understanding of the genetics underlying the diseases. The study will help in identifying new and better drugs, specific for the above-mentioned disorders. The discovery will lead to identifying bio molecules for the accurate prediction of the disease manifestation.

Avesthagen aims to facilitate predictive, preventive and personalized approach for diagnosis and treatment for cancer, metabolic and neurological disorders. Avesthagen has adopted a holistic approach applying state-of-the-art technology to not only come up with therapies, but go one step further in developing the most sensitive means of prediction and diagnosis. In its development program Avesthagen’s biopharmaceutical division also has a strong focus and drug portfolio pipeline on oncology and other above-mentioned disorders. Another major breakthrough by the company, in this field is the discovery of novel signature metabolites for Cancer, which is currently in the phase of clinical validation.

http://www.tgac.bbsrc.ac.uk/news/2010/100902Avestagenome.html
http://www.thehindubusinessline.in/2010/09/07/stories/2010090753650300.htm
http://www.genomeweb.com/sequencing/avestagenome-project-researchers-sequence-parsi-breast-cancer-genome
http://timesofindia.indiatimes.com/india/Genome-decoded-now-Parsi-ills-can-be-tackled/articleshow/7496919.cms

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Extending pathways and processes using molecular interaction networks to analyse cancer genome data

This something really interesting to PPI, Systems biology  and molecular networks people, I just recently came across,

Cellular processes and pathways, whose deregulation may contribute to the development of cancers, are often represented as cascades of proteins transmitting a signal from the cell surface to the nucleus. However, recent functional genomic experiments have identified thousands of interactions for the signalling canonical proteins, challenging the traditional view of pathways as independent functional entities.

Combining information from pathway databases and interaction networks obtained from functional genomic experiments is therefore a promising strategy to obtain more robust pathway and process representations, facilitating the study of cancer-related pathways. 

Results: We present a methodology for extending pre-defined protein sets representing cellular pathways and processes by mapping them onto a protein-protein interaction network, and extending them to include densely interconnected interaction partners. The added proteins display distinctive network topological features and molecular function annotations, and can be proposed as putative new components, and/or as regulators of the communication between the different cellular processes.

Finally, these extended pathways and processes are used to analyse their enrichment in pancreatic mutated genes. Significant associations between mutated genes and certain processes are identified, enabling an analysis of the influence of previously non-annotated cancer mutated genes. 

Conclusions: The proposed method for extending cellular pathways helps to explain the functions of cancer mutated genes by exploiting the synergies of canonical knowledge and large-scale interaction data.

Author: Enrico GlaabAnais BaudotNatalio KrasnogorAlfonso Valencia

Credits/Source: BMC Bioinformatics 2010, 11:597

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Extending pathways and processes using molecular interaction networks to analyse cancer genome data

This something really interesting to PPI, Systems biology  and molecular networks people, I just recently came across,

Cellular processes and pathways, whose deregulation may contribute to the development of cancers, are often represented as cascades of proteins transmitting a signal from the cell surface to the nucleus. However, recent functional genomic experiments have identified thousands of interactions for the signalling canonical proteins, challenging the traditional view of pathways as independent functional entities.

Combining information from pathway databases and interaction networks obtained from functional genomic experiments is therefore a promising strategy to obtain more robust pathway and process representations, facilitating the study of cancer-related pathways. 

Results: We present a methodology for extending pre-defined protein sets representing cellular pathways and processes by mapping them onto a protein-protein interaction network, and extending them to include densely interconnected interaction partners. The added proteins display distinctive network topological features and molecular function annotations, and can be proposed as putative new components, and/or as regulators of the communication between the different cellular processes.

Finally, these extended pathways and processes are used to analyse their enrichment in pancreatic mutated genes. Significant associations between mutated genes and certain processes are identified, enabling an analysis of the influence of previously non-annotated cancer mutated genes. 

Conclusions: The proposed method for extending cellular pathways helps to explain the functions of cancer mutated genes by exploiting the synergies of canonical knowledge and large-scale interaction data.

Author: Enrico GlaabAnais BaudotNatalio KrasnogorAlfonso Valencia

Credits/Source: BMC Bioinformatics 2010, 11:597

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Roche Enters $1.1B Drug Deal With US’s Aileron Therapeutics for New Stapled Peptide Therapeutics

Aileron Therapeutics and Roche announced today that they have entered into a collaboration to discover, develop and commercialise a new class of drugs called Stapled Peptide Therapeutics. As part of this agreement, Roche will work with Aileron to develop drug candidates against up to five undisclosed targets selected from Roche’s key therapeutic areas, which include oncology, virology, inflammation, metabolism and CNS.

Stapled Peptide Therapeutics are a result of Aileron’s breakthrough peptide stabilization technology, and are a potential solution to drug as-yet intractable disease targets, including those originating from long sought-after intracellular protein-protein interactions.

Under the terms of the agreement, Roche will provide Aileron guaranteed funding of at least $25 million in technology access fees and R&D support. Aileron is eligible to receive up to $1.1 billion in payments upon the achievement of discovery, development, regulatory and commercialisation milestones, if drug candidates are developed against all five targets. In addition, Aileron will receive royalties on future sales for any marketed products that result from the collaboration. Aileron will have substantial responsibility in collaboration with Roche to develop drug candidates against the selected targets up to clinical development.


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