The Clearity Foundation: Bringing tumor typing to ovarian cancer
Selecting the appropriate chemotherapy for individual women with ovarian cancer is still a trial and error endeavor that involves more than a dozen different potential therapies. Finding the right drug takes time, delays effective treatment and is expensive, both for patients and for insurers.
The Clearity Foundation is working to change that. The foundation works with patients and physicians to coordinate ovarian tumor profiling, help patients and their medical teams choose the therapies that are most effective against their specific tumors, and alert them to clinical trials that are appropriate for their individual situations.
Tumor profiling isn’t routinely used for ovarian cancer, although it is usual for many other cancers. That realization spurred researcher Laura Shawver, PhD, to found the Clearity Foundation in 2007—one year after she, herself, was diagnosed with ovarian cancer.
Since then, the foundation has developed a way to generate personalized diagnostic information using commercially available molecular profiling technologies, and has developed the Diane Barton Database of tumor biomarkers for ovarian cancer. The anonymized database also tracks treatment outcomes of women with ovarian cancer, thus correlating tumor profiles with treatments and outcomes. This is particularly important because ovarian tumors vary significantly among patients, causing them to respond differently, or not at all, to any given drug.
Specifically, Hillary Theakston, executive director, explained, “We work with patients to have their formalin-fixed paraffin-embedded (FFPE) tissue samples sent from their hospital’s pathology lab to the diagnostic lab, and we determine which tests to perform.” The results are added to the Diane Barton Database, and compared to the 200 samples currently there as well as to published clinical research of biomarkers to identify which chemotherapies would be most effective for specific patients, thus helping patients and their treatment teams make better informed decisions.
“Awareness of Clearity Foundation, so far, is very low,” Theakston admitted. “Each year, about 22,000 patients are diagnosed with ovarian cancer and 15,000 women die of ovarian cancer. Today we have funding to support about 100 patients per year and we would like to increase our capacity to reach thousands.” Partially, the low awareness factor stems from statistics. “Breast cancer, for example, is 10 times more prevalent than ovarian cancer, so there’s more awareness of the importance of early detection. There also are more survivors and, therefore, more advocates,” she added. “In contrast, ovarian cancer is one-tenth the number and much more deadly.”
Theakston joined the foundation in January to help increase the organization’s ability to reach more patients. An energetic awareness campaign has resulted in an April article in Oprah Winfrey’s “O” magazine. “Our first objective is to create awareness that ovarian tumor profiling is even an option,” she said.
To do that, the Clearity Foundation has participated in scientific conferences, presented posters at the recent American Association for Cancer Research and American Society of Clinical Oncology conferences, will exhibit at BIO International Convention in Washington, DC in June, and will actively engage potential partners at BioPharm America™ in Boston in September.
The Clearity Foundation also is beginning conversations with like-minded organizations to support more patients and improve public awareness and clinical education. Although the foundation focuses upon ovarian cancer, “there are a number of other difficult-to-treat cancers that could benefit from a personalized diagnostic approach,” Theakston pointed out. Therefore, the Diane Barton Database and the Clearity Foundation’s expertise in helping to identify personalized therapies for ovarian cancer patients may be tapped successfully for related conditions. “Personalized medicine is making the organ of origin less relevant than the molecular markers involved in disease,” she emphasized.
“We are working with researchers and with other organizations to get the word out to their constituents,” Theakston said. “We have a number of partnerships with diagnostic and therapeutic companies that can benefit from the information in the Diane Barton Database, which identifies relevant biomarkers in ovarian cancer and what they may mean for therapeutic efficacy,” she elaborated.
The Clearity Foundation works with biotech and pharmaceutical companies to help them with their clinical trial design and patient recruiting, as well as to help develop clinical education for physicians regarding the options and value of molecular profiling and personalized medicine. Some current Foundation partners include the diagnostic and therapeutic developers Abbott, Clarient, IlluminaDX, Morphotek, Nektar, sanofi-aventis, and Ventana, as well as the logistics and distribution firm of McKesson Corporation. “We’re looking for corporate sponsors,” Theakston said. One important project is to develop continuing medical education (CME) courses for professional societies. “We would love to do continuing medical education work,” Theakston said, “and we would like to develop a speakers bureau.”
The Clearity Foundation is also interested in working with other nonprofit organizations. Mutual benefits could result from partnering with other cancer foundations. As she explained, “We could use our database to provide support in helping patients make more informed medical decisions. The Livestrong Foundation is a good example of a potential partner. Pairing Clearity’s Diane Barton Database with Livestrong’s broad spectrum of cancer navigation services could help patients and their clinical teams select the best treatment options and identify appropriate clinical trials.”
Third party payers also are increasingly interested in personalized medicine to improve both economic and clinical outcomes. Currently, as Theakston noted, “For women with recurrent ovarian cancer, there is no process to select the next agent from the more than one dozen choices.” The data in the foundation’s database could help remedy that situation.
The Clearity Foundation’s primary focus is to improve awareness of its services among ovarian cancer patients and clinicians, Theakston emphasized. Once that is accomplished, Theakston said she would like to enhance the foundation’s services within ovarian cancer and to spearhead prospective clinical trials that use molecular profiling to inform treatment decisions. That includes increasing the numbers of biomarkers that are considered in tumor profiling as well as expanding into other difficult-to-treat cancers, she said.
The Clearity Foundation is guided by a scientific board that Theakston described as “top notch.” It includes Julie Cherrington, PhD, CEO of Pathway Therapeutics; Beth Y. Karlan, MD, director of the Women’s Cancer Research Institute at the University of California, Los Angeles; Johnathan Lancaster, MD, PhD, director of the Center for Women’s Oncology and its translational research laboratory at the H. Lee Moffitt Cancer Center in Tampa, Florida; Douglas A. Levine, MD, gynecologic oncologist at Memorial Sloan Kettering Cancer Center in New York City; and Ursula A. Matulonis, MD, assistant professor of medicine at Harvard Medical School, and the medical director and program leader of the Medical Gynecologic Oncology Program at Dana-Farber Cancer Institute in Boston, Massachusetts. The scientific director is cancer biologist Deborah Zajchowski, PhD, a researcher with some 20 years experience in cancer research and drug discovery in the biopharmaceutical industry.
“Most of the funding has come from our founder and individual board members, as well as corporate sponsors and events that provide sponsorship. We are applying for Department of Defense grants,” Theakston said. The Clearity Foundation also has won the support of the financial firms Blueprint Life Science Group, CMEA Capital, Credit Suisse, 5AM Ventures, and Smith Barney as Foundation partners, as well as the communications firms Canale Communications and Taylor & Pond, and the legal firm Goodwin Proctor.
By bringing tumor profiling to ovarian cancer, the Clearity Foundation and its partners are bringing the value of personalized medicine to an underserved segment of the population, improving outcomes for patients and streamlining diagnostics and therapeutics development for companies working in this arena.
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