Cancer Prevention Pharmaceuticals, Inc. (CPP), a private clinical stage biotech company developing novel therapeutics to prevent cancer and other diseases, announced today the appointment of Willene Brondum as its new Associate Vice President of Regulatory Affairs and Quality Assurance.
Ms. Brondum will lead all of CPP’s regulatory and quality assurance operations for its advancing pipeline including preparations for submission to the Food and Drug Administration (FDA) of a New Drug Application (NDA) for CPP’s lead drug CPP-1X/sul. CPP-1X/sul is currently in a pivotal Phase 3 clinical trial for adults with familial adenomatous polyposis (FAP).
FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. Currently there is no effective treatment for FAP. In 2017, the FDA granted “fast-track” status for CPP-1X/sul and previously also granted CPP-1X/sul orphan drug status.
“We are pleased that a person with Willene’s more than two decades of regulatory experience in the pharmaceutical industry, including knowledge of orphan drugs, will be joining the CPP team,” said Jeff Jacob, Chair and CEO of CPP. “We are on a streamlined path to NDA filings and potential commercialization with CPP-1X/sul; we believe someone with Willene’s strong background in FDA pre- and-post marketing submissions will be vital in getting this much-needed drug to patients as quickly as possible.”
“I am very excited to lead CPP’s regulatory operations for all its drug assets and especially in its goal to bring CPP-1X/sul through the FDA approval process and ultimately to very sick people who have no effective treatment,” said Brondum.
Ms. Brondum was most recently Director of Regulatory Affairs at NEOS Therapeutics where she directed strategies for development, registration and lifecycle management of three of NEOS’ drug products. She has also managed regulatory affairs at Insys Therapeutics, Medicis Pharmaceutical Corporation and DSM Pharmaceuticals, as well as Geneva Pharmaceuticals (now Sandoz). Ms. Brondum holds a BS from the University of Kansas.
The FAP-310 clinical trial is a randomized, double-blind, Phase 3 trial designed to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. An Independent Data Monitoring Committee in June recommended continuation of the Phase 3 trial, which is expected to be complete in 2018. For more information on the clinical trial (CPP FAP-310), please visit: https://clinicaltrials.gov/ct2/show/NCT01483144.
About Cancer Prevention Pharmaceuticals, Inc.
Cancer Prevention Pharmaceuticals, Inc. (CPP) is developing therapeutics designed to reduce the risk of cancer and other diseases. In addition to the CPP FAP-310 trial, CPP is co-sponsoring with the National Cancer Institute (NCI) and SWOG a large Phase 3 trial in colon cancer survivors. CPP is also working collaboratively with nonprofit groups to support their clinical trials in neuroblastoma, gastric cancer, and early-onset type 1 diabetes. CPP is located in Tucson, Arizona. For more information, please visit www.canprevent.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the benefits of Fast Track Status. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Investor Contact: Chris Richied, CFO, Cancer Prevention Pharmaceuticals, Inc, +1.520.908.7774
Media Contact: Christine Brannen, Cancer Prevention Pharmaceuticals, Inc., firstname.lastname@example.org, +1.520.908.7774