AUSTIN, Texas, May 21, 2015 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, announced today that it has been approved for a product development grant from the Cancer Prevention and Research Institute of Texas (CPRIT) for $7.5 million, to help fund the Company's new multi-site pelvic mass registry. The grant would assist Vermillion in creating a first-in-kind clinical registry of patients undergoing evaluation, diagnosis, treatment and follow-up for pelvic masses that may lead to gynecologic malignancy. The registry would be headquartered in Austin and would be a centralized strategic asset in Vermillion's mission to improve care for ovarian cancer and other important gynecologic conditions. Receipt of the grant award is subject to execution of a grant contract on terms acceptable to both Vermillion and CPRIT and may include such terms as payment of future product royalties to CPRIT by Vermillion.
This planned registry differs from previous clinical trials conducted by Vermillion for its OVA1® and OVA2 (second-generation OVA1) tests in several important ways:
- Patients will be enrolled at the time a suspicious pelvic mass is first identified
- Up to ten "hub sites" will manage patient enrollment regionally under the leadership of nationally-renowned clinical academicians
- Enrollment will come from a broad spectrum of naturally-presenting gynecologic diseases requiring differential diagnosis for ovarian cancer
- Patients will be followed and data collected longitudinally through evaluation, eventual surgery, diagnosis and early outcomes
- In addition to serum biomarkers, Vermillion plans to investigate imaging, other molecular markers, symptoms and clinical risk factors. Vermillion has referred to this multi-modal diagnostic approach as its "bio-analytic" technology platform
The first output of the registry is expected to be a validated, semi-quantitative risk assessment algorithm that will assist physicians in managing patients at risk for ovarian cancer. The pelvic mass registry will also enable the research and development by Vermillion of intellectual property and products that can be applied to other gynecologic diseases such as early diagnosis of endometriosis, fibroids or polycystic ovaries.
The registry will be co-led by Dr. Jubilee Brown from M.D. Anderson Cancer Center in Houston, Dr. Judith Wolf, Vermillion's Chief Medical Officer, and Dr. Donald Munroe, Vermillion's Chief Scientific Officer.
Dr. Wolf stated, "We are honored by CPRIT's interest in investing in our vision to drive better ovarian cancer care. The unmet needs in ovarian cancer are serious and urgent, and we believe this grant would directly contribute to innovative solutions." Dr. Munroe added, "This funding would accelerate the pace at which we create this multi-product, multi-disease clinical registry. But in addition, it would catalyze Vermillion's strategic growth by funding clinical infrastructure, clinical staffing and expanded technical assets."
"Our mission is to understand the pelvic mass disease pathways for both benign and malignant disease. The approval of this grant is a testament to our overall registry plan, process and our forward thinking. The approval of this grant is truly a capstone achievement for Vermillion as well as for the large population of patients it is expected to serve," said Valerie Palmieri, Vermillion's President and CEO.
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, have diagnostic programs in gynecologic disease. The company's lead diagnostic, OVA1, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.
- OVA1 is a proprietary FDA-cleared blood test to help physicians assess the risk of ovarian cancer prior to surgery and trigger the involvement of a specialist (gynecologic oncologist) for higher risk patients;
- The OvaCalc® proprietary algorithm combines five biomarker results into a single numerical "risk score" that stratifies patients into "higher risk" and "lower risk" when combined with clinical assessment;
- In two pivotal clinical trials, OVA1 plus clinical impression detected 96% of all malignancies vs. 75% for clinical impression alone. It subsequently reduced the number of malignancies missed from 25% to 4%, a reduction of 83%
About the Cancer Prevention and Research Institute of Texas
Beginning operations in 2009, CPRIT has to date awarded more than $1 billion in grants to Texas researchers, institutions, non-profits and private enterprises. CPRIT provides funding through its research – scientific and product development – and prevention programs. Learn more at cprit.state.tx.us.
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements regarding the CPRIT grant, the use of any funds received from CPRIT and the plans for the multi-site pelvic mass registry. Words such as "may," "expects," "intends," "anticipates," "believes," "estimates," "plans," "seeks," "could," "should," "continue," "will," "potential," "projects" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion's expectations as of the date of this press release. There is no assurance that any grant contract will be executed by Vermillion and CPRIT, and therefore, there is no assurance that Vermillion will receive any grant funds from CPRIT. A variety of other factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements, including those that are described in Vermillion's Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission. Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
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SOURCE Vermillion, Inc.