One way or the other, Merrimack Pharmaceuticals Inc (NASDAQ: MACK), Covidien plc (NYSE: COV), NeoGenomics, Inc (NASDAQ: NEO) and CollabRx Inc (NASDAQ: CLRX) are targeting Barrett's Esophagus or esophageal cancer (the former often leads to the latter) – a form of cancer that may not be on the top of your list of cancers but is nevertheless on the rise. Approximately 3 million Americans suffer from Barrett's Esophagus, a condition that develops as a result of chronic injury from gastroesophageal reflux disease (GERD) where the normal esophageal lining is replaced with abnormal cells (known as Barrett's tissue), putting patients at greater risk of developing cancer of the esophagus. And although less than 1% of these patients develop cancer each year, esophageal carcinoma is frequently not detected until later stages, at which point therapy options are limited, extremely invasive, and often ineffective. This means that early detection is important along with regular surveillance is recommended.
Otherwise, other risk factors for esophageal cancer include smoking tobacco and heavy use of alcohol while people who are infected with human papilloma virus are also at increased risk. Most people who develop esophageal cancer will be in their 50's to 70's, they will more likely be men than women and its more common among African-Americans than among Caucasians. The American Cancer Society estimates that more than 18,000 Americans will be diagnosed with esophageal cancer in 2014 and more than 15,000 people will die from the disease.
As for investing in esophageal cancer treatments or tests to detect it, small cap Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. In August 2013, Merrimack Pharmaceuticals announced that the FDA's Office of Orphan Products Development had granted two separate orphan drug designations for its bispecific antibody, MM-111, for the treatment of esophageal cancer and for the treatment of gastric as well as gastroesophageal junction (GEJ) cancers. The Vice President of Clinical Investigations commented in the announcement that:
"We are pleased that the FDA has granted orphan status designation for the development of MM-111 in these two indications. Patients with HER2-expressing gastric and esophageal cancers have limited treatment options. We are excited to move forward with the development of MM-111 and hope to positively impact the lives of these patients by addressing an unmet medical need."
MM-111 is being tested in a Phase 2 study in advanced gastric, esophageal and gastroesophageal junction cancers with the latest information about the trial available here.
Meanwhile, Ireland based large cap Covidien plc develops, manufactures and sells a diverse range of industry-leading medical device and supply products. Back in March, Covidien plc announced that its technology is effective at treating Barrett's Esophagus, according to a clinical study published in The Journal of the American Medical Association (JAMA). The so-called SURF Trial (SUrveillance vs. RadioFrequency ablation) was a multi-center, randomized, investigator-sponsored clinical trial that compared the Covidien Barrx™ RF Ablation System with endoscopic surveillance in patients with Barrett's Esophagus and a confirmed diagnosis of low-grade dysplasia. According to the lead investigator:
"In patients with Barrett's esophagus containing confirmed low-grade dysplasia, endoscopic ablation significantly reduced disease progression to high-grade dysplasia and esophageal cancer as compared to surveillance alone. The difference in the disease progression outcome between the two groups was so large, in fact, that the data safety monitoring board overseeing the trial recommended early stoppage of the trial and patients in the control group were then offered endoscopic ablation."
In addition and near the end of 2012, small cap NeoGenomics, a leading provider of cancer-focused genetic testing services, announced that it had validated and launched a laboratory developed Fluorescent in Situ Hybridization assay for the surveillance of patients with Barrett's Esophagus. The test from NeoGenomics is highly sensitive for the detection of the presence of esophageal cancer or high grade dysplasia indicative of precancerous changes. Moreover, current data suggests that an esophageal "brushing" may be more effective than a traditional tissue biopsy because it allows for the collection of cells from a larger area of the esophagus for testing and they are also generally easier and less costly to obtain than tissue biopsies. Hence, NeoGenomics' NeoSITE™ Barrett's Esophagus FISH test was designed specifically to be performed on brushing samples and can be used as an objective and easier means to aid in routine surveillance of BE patients.
Finally, small cap CollabRx Inc is more of an indirect play on specific cancers like esophageal cancer because it uses information technology to aggregate and contextualize the world's knowledge on genomics-based medicine with insights from the nation's top cancer experts starting with the area of greatest need: advanced cancers in patients who have effectively exhausted the standard of care. Yesterday, CollabRx Inc announced the publication of an abstract in the 2014 ASCO Annual Meeting Proceedings, entitled:
Genetic alterations in esophageal cancers: Detection by next-generation sequencing and potential for therapeutic targets
The abstract summarizes the results of a clinical study conducted by physicians and clinical researchers at CollabRx Inc, the University of Chicago and the University of Wisconsin. The goal of the study was to pair tumor genetic alterations derived from an established next generation sequencing (NGS) platform with actionable information that can be used to inform individual patient treatment planning. CollabRx will be discussing the abstract and GVA Service at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3, 2014 in Chicago.
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