As many who are familiar with me may recall, my mother lost her battle with lung cancer approximately 19 months ago. Since that time, whenever I am trolling for news and items that I might be able to write about, I am continually drawn to news items discussing cancer research.
As anyone who is familiar with clinical trials know, there is no guarantee that even exciting therapies will ever make it to market, much less have a positive impact on patients. Still, the research has to start somewhere and science moves at a deliberate pace. As Thomas Edison even famously quipped, even a failure is successful at teaching what is now not possible.
Positive news stories about cancer research and development also provide hope. Cancer has taken far too many lives. With continued, concerted effort, eventually it will be eradicated. Whether that will be in our lifetime…who knows. It certainly won’t be if patent rights continue to erode. Without strong patent rights, there just isn’t going to be the incentive to pursue speculative therapies, drugs and treatments that cost hundreds of millions of dollars to develop and take to market…particularly when so many fail.
In any event, as I was looking for interesting things to write about, I stumbled across a pair of potentially interesting items…one dealing with pancreatic cancer and the other dealing with prostate cancer. For more information on FDA, pharma and biotech law, please also check these PLI resources:
- Healthcare and Life Sciences Law
- A Practical Guide to Life Science Companies: Commercializing & Protecting Innovation
- Pharmaceutical Compliance and Enforcement Answer Book
- Pharmaceutical and Biotech Patent Law
Pancreatic Cancer
Trovagene, Inc., a developer of cell-free molecular diagnostics, and US Oncology Research, a community-based research program in the United States, announced recently that they have entered into a Clinical Study Agreement to examine the utility of quantitative urine-based KRAS mutation detection and monitoring in pancreatic cancer patients.
The core objective of the study is to determine whether there is clinical value to Trovagene’s proprietary cell-free DNA platform for the detection and monitoring of oncogene mutations in urine. In addition to other clinical studies evaluating Trovagene’s novel molecular diagnostics, the US Oncology Research collaboration is the first multi-site study sponsored by Trovagene.
Pancreatic cancer is considered to be one of the most deadly cancers due to its aggressive nature and its typically advanced stage at initial diagnosis. The American Cancer Society estimates that in 2013, 44,220 people in the United States were diagnosed with pancreatic cancer and about 38,460 will die from the disease. An estimated 80% of pancreatic cancer patients have inoperable or metastatic disease, and upwards to 95 percent of pancreatic cancers are thought to have KRAS mutations. Based on these statistics, the need for an accurate, cost-effective test to detect and monitor patients is obvious.
“We desperately need new ways to follow our patients with pancreatic cancer, particularly those without any other markers,” stated Dr. Daniel Von Hoff, Medical Director of Research and Scientific Medical Officer, McKesson Specialty Health and The US Oncology Network.
In this relationship, Trovagene is leveraging its patented technology for the detection of cell-free DNA and RNA short nucleic acid fragments that originate from normal and diseased cell death. They can be isolated and detected from urine. US Oncology Research contributes an experienced network of investigators and clinical staff who specialize in Phase I through Phase IV oncology clinical trials. In addition to the 11 US Oncology Research-affiliated community cancer care sites participating in this study, academic research institutions that specialize in oncology will also participate.
Prostate Cancer
Interim results from a clinical trial of Prostate Health Cocktail (PHC®) show promise that OncoNatural’s over-the-counter dietary supplement may be a useful adjunct treatment for prostate disease. Prostate specific antigen, or PSA, was effectively stabilized in more than 83% of study participants. Equally important, PHC demonstrated far less impact on quality of life and physical wellbeing when compared with traditional hormone therapy.
The recent study looked specifically at the problem of men who experience rising PSA levels despite successful treatment of initial prostate cancer. These men face a significant risk of recurrence. In fact, one in five will die from the disease. Unfortunately, the current strategies for dealing with biochemically recurrent prostate cancer represent a difficult risk-benefit analysis. Observation and imaging tests may still catch new tumors too late. On the other hand, proactive hormone therapy brings with it a host of unpleasant side effects. Prostate Health Cocktail may be the answer to this dilemma.
Conducted at the Norris Comprehensive Cancer Center at the University of Southern California, the 4-year PHC study enrolled 40 men with a median age of 67. Eligibility requirements included rising PSA and no evidence of current tumor growth. The treatment regimen consisted of three PHC capsules a day in four-week cycles. Researchers assessed toxicity and PSA levels at the end of the first four-week cycle. Afterwards, assessments were made every two months for up to a year. Anyone showing rising levels of PSA was removed from the study.
Of the 40 men who participated, 15 saw declining levels of PSA at some point during the study, and more than 83% saw their levels hold steady. In the context of traditional hormone therapies and grueling cancer treatments, the side effects of PHC are relatively benign. The most common complaint was gastrointestinal discomfort, followed by a few instances of minor weakness, dizziness or pain. These complaints pale in comparison to the possible effects of hormone therapy.
Of course, PHC cannot replace traditional cancer treatments, such as radiation, chemotherapy and surgery, but ideally it could enhance long-term prognosis for men with biochemically recurrent prostate disease. The ultimate goal is to hopefully give doctors a weapon against recurring prostate cancer that’s more precise and perhaps even more effective than the blunt hammer of hormone therapy, which has long been among the standard treatments for prostate cancer.
Tags: cancer, cancer research, pharma, scientific research
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