Biomarking the future of medicine.

Drug developers, genomic companies strive for more personalized medicine

Drug developers in clinical trials increasingly are evaluating biomarkers, the human traits that differentiate one of us from all others.

The development of these assays likely will lead to a wave of personally-tailored drugs and economical drug testing.

Witness Genentech (NYSE: DNA, Stock Forum), which this week detailed Phase III details of its lung cancer treatment Tarceva on humans. Whilst the first, or primary, endpoint of the drug study was “progression-free survival, secondary endpoints included the evaluation of exploratory biomarkers.”

Five years ago, we saw no such evaluations of these diagnostic tools, which narrow the number of patients entered into placebo/randomized drug trials. Genentech used diagnostic tools to narrow the patients enrolled in its spectacularly successful Herceptin trials for breast cancer.

Human beings have much to applaud in large and small companies’ and labs’ development of assays that identify proteins, amino acids and other body chemicals and traits that reveal the progress of a disease.

As livers of life, we can hope that doctors soon will prescribe treatments meant for you and me as individuals and not just male/white/western European or female/black/east African.

As drug testers at biomedical companies, we can hope to see economical testing of targeted patient populations. Clinical trials – from animal testing through human placebo-controlled studies – are way, way expensive. Thus, spending on a drug for a specific type of, say, breast cancer patient is narrowed.

As investors, we can support companies that appear to be devoting resources to assays for everything from mental retardation to psoriasis to cancers, tumors and blood ailments.

There is, JUST in the past two to three years, a treasure trove of information about biomarkers and testing. The current platinum standard probably goes to Herceptin. As described by the American Association for Cancer Research, the HER2 (human epidermal growth factor receptor 2) gene “is part of a family of genes that play roles in regulating cell growth.”

A number of breast cancers “undergo gene amplification.” This makes the tumors “more aggressive and less sensitive to chemotherapy and hormone therapy,” the association says. At least 50,000 Canadian and American women get diagnosed with HER2-positive breast cancer each year.

Road to success

Investors have reason to applaud – within reason, that is. The road to successful diagnostic tools is paved with R&D bricks, as in money-money-money. Plus, regulators and independent labs are ensuring the biomarker tools are finding genuine traits that indicate disease progression and not phony ones, senseless ones or widespread ones.

At medical conferences around the globe, researchers are filing poster boards and other abstracts that paint a promising but difficult path to success. At one of them I recently came across, Sandor Szalma, director of Discovery Informatics at Centocor, wrote, “The number of molecular platforms enabling translational research for biomarker discovery is steadily increasing. So does the plethora of algorithms and approaches aimed at interpreting the data from these different experimental modalities.”

Szsalma goes on to write that his team selected a set of related autoimmune disorders (psoriasis, psoriatic arthritis and rheumatoid arthritis) “to illustrate the challenges and possible solutions on the path toward biomarker discovery. The strengths and weaknesses of the applied informatics solutions … in pharmaceutical drug discovery settings are discussed in great depth.”

At another conference, Stephen M. Hewitt, head of Tissue Array Research for the National Cancer Institute, explained in a report, “There are a multitude of biomarker discovery platforms, each which produce useful but complex data. Reducing these potential clinically relevant biomarkers to clinical utility remains a bottleneck. The demands of diagnostic pathology and clinical medicine limit the utility of many potential biomarker platforms.”

The Food & Drug Administration in the U.S., the Medicines and Healthcare products Regulatory Agency in England and Health Canada up north are spending a lot more time the days looking at biomarkers and their roles in diagnostic tools for labs, companies and individuals. Concerns include the way that these tools are vetted, or validated by companies that hope to commercialize both the assays and the drugs that these assays spawn.

Other concerns include the comprehension of the algorithms and data that are used to single out useful traits in humans, and in some cases, animals. In addition, the way that labs and clinics operate to produce and test assays is a subject for regulators.

The ThomWatch take is that regulators are hopeful biomarkers and diagnostics will create economical health care at a time of soaring costs. The promise of genomic tools and their genotyping ability to decipher our bodily fluids is part of all this. Indeed, CEO Jay Flatley at Illumina (NASDAQ: ILMN, Stock Forum), a U.S. genomic tools company whose shares we have owned for five years, tells me he and his scientists are working on a set of diagnostic tools for commercial use.

That’s it for now. Stockhouse.com, is  working earnestly on a new subscription (translation: cost$ money) report that will be published later this month. Stockhouse is pleased to announce the name of the new report, Ticker Trax By Thom Calandra.

As stated here in our free ThomWatch, I believe we will experience a return to sensible asset values soon in risky investments … and indeed, some small companies in life sciences, mostly cancer compound developers, already are showing some life.

Ticker Trax By Thom Calandra will explore the planet we live on in a search for the very few stakes that could offer excellent, in some cases cosmic, returns. It is only for those who are entirely at ease with ultra-intense levels of risk and willing to endure pain, suffering, shingles perhaps but some very, very fine meals and thin-crust pizza in all its planetary forms.

Note: Thom’s cosmos of holdings is listed for free Stockhouse members on www.Stockhouse.com under the “portfolio setting” for user TCALANDRA. For more ThomWatch, please see Stockhouse and ThomCalandra.blogspot.com.

TICKER TRAX: For investors who profited from a meteoric rise of commodities, mining and life sciences companies, Thom Calandra acted as a beacon. Thom helped his audience find value in a quagmire of investment choices. Thom co-founded and was the driving editorial force and spirit of CBS MarketWatch, MarketWatch.com and FT MarketWatch in Europe. As the voice of Thom Calandra's StockWatch and The Calandra Report, Thom fancied $300-ounce gold before that metal became an investment rage. Thom visited bioscience companies, metals mines and scores of thin-crust pie joints across the planet in a search for profit, fashion and pizze de trippa gorgonzola. Thom's novel PABLO BY NUMBERS was completed in summer 2008. He and Stockhouse later this autumn will offer a DELUXE VERSION of ThomWatch as a subscription report for a select audience: Ticker Trax By Thom Calandra.

ABOUT THE AUTHOR

     Thom Calandra

Watch for a new subscription service on Stockhouse featuring Thom Calandra, coming this autumn. It is tentatively titled Thom Calandra Report.

For a wide-ranging interview with Thom, please see Stockhouse's series of articles: Taking Stock of Thom. He and his family live in Tiburon, California. Visit his web homes at www.thomcalandra.com and thomcalandra.blogspot.com.