Loading...
No BYH to today's BYH stating you didn't vote because there was no one to vote for, well, there sure was someone to...

Pharmaceutical company to begin clinical trial

Loading…

Monday, January 1, 2018

Fervent Pharmaceuticals of Greenville has successfully submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for FP-101, its proprietary lead drug candidate for treating menopause symptoms, especially hot flashes.

A Phase 2a clinical trial will now begin to assess the therapeutic potential of FP-101 in post-menopausal women. The trial will get underway in the first quarter of this year and will enroll 110 women at a dozen study sites in Illinois, North Carolina, South Carolina and Tennessee.

The North Carolina sites are in Cary, Charlotte, Hickory, Raleigh, Rocky Mount, Salisbury, Wilmington and Winston-Salem.

"We believe FP-101 has the potential to bring relief to millions of women suffering from hot flashes, night sweats and insomnia associated with menopause," said George Royster, founder, president and chief executive officer of Fervent. “Achievement of this regulatory milestone and the beginning of our clinical trial represents an important advancement in the development of FP-101.”

FP-101 is an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, is already FDA approved for another undisclosed indication and has a history of safe use. Its potential for treating the symptoms of menopause was discovered through “serendipity and a keen eye for detail and observation,” Royster said.

Most FDA-approved treatments of symptoms in post-menopausal women involve estrogen hormone replacement therapy, which carries an increased risk of heart disease, breast cancer, deep vein thrombosis, stroke and gall bladder disease.

Development of safe and effective new therapies would fill a significant unmet medical need. The U.S. market for a therapy includes 32 million women, and the global market encompasses 115 million women.

The total market “is in the multi-billion-dollar arena,” Royster said.

Fervent has received assistance from the North Carolina Biotechnology Center and its Eastern Regional Office, headed by Mark Phillips, vice president of statewide operations and executive director of the office.

“The expertise and networking assistance provided by Mark and the Biotechnology Center have been very helpful to our company’s growth and development,” Royster said.

The company is working with the University of Iowa Pharmaceuticals on drug formulation and with IQVIA (formerly QuintilesIMS) of Durham and PMG Research of Winston-Salem for clinical trial design and execution.

Fervent is a clinical-stage drug development company founded in 2011. It is focused on developing therapies targeting unmet medical needs in women’s health.

For more information about Fervent, visit the company’s website at www.ferventpharma.com.

Loading…

Humans of Greenville

@HumansofGville

Local photographer Joe Pellegrino explores Greenville to create a photographic census of its people.

Workweek

July 16, 2018

The following civil lawsuits were filed June 12-June 19 in Pitt County:

■ Branch Banking & Trust Co. v. Matthew J. Ashorn, collection on account, June 12; 18CVD 1703.

■ OneMain Financial Group LLC v. Crystal Little, collection on account, June 12; 18CVD 1704.

■ Wentworth Construction…

July 16, 2018

GREENVILLE

The City of Greenville Inspections Department issued the following permits for July 3-July 9:

■ Po Han Kwon and Corey Layton Kwon, 2114 Royal Drive, single-family alteration, $15,000.

■ Keystone Management Co., 120 River Bluff Road, multifamily alterations/repairs, $4,835.…

July 16, 2018

PCC staff gives classroom management presentation

For the second year in a row, Pitt Community College’s Jasmin Spain and Nicholas Vick gave a presentation on classroom management during the National Institute for Staff and Organization Development’s (NISOD) International Conference on…

071618WWPCC.jpg

July 16, 2018

Towne Insurance, ranked by revenue as one of the nation’s largest, independent insurance brokers, today announced they are expanding their current relationship with Nationwide through the completion of its acquisition of Charlotte’s largest Independent Nationwide agency. Founded in 1994…

July 16, 2018

Chocowinity native takes part in imaritime warfare exercise

PEARL HARBOR — A 2017 Southside High School graduate and Chocowinity native is serving in the U.S. Navy as part of the world’s largest international maritime warfare exercise, Rim of the Pacific (RIMPAC).

Seaman Apprentice…

Harris_Ethan.jpg

July 16, 2018

MONDAY: The Pitt Community College Small Business Center is hosting a free seminar from 6-9 p.m. entitled ‘What is an Income Statement?’ Learn how an income statement works, what it contains, and where the numbers come from. Contact Wendy Dunbar at 493-7528 or wdunbar@email.pittcc.edu…

July 16, 2018

An Eastern North Carolina radio station in Rocky Mount is the latest company to be moving to the Rocky Mount Mills.

Life 103.1 WLQC-FM will be moving from its current location at 3048 Zebulon Road and occupy 2,100-square-feet of space in the main mill building being remodeled on the campus of the…

070918radiostation.jpg

July 16, 2018

FARMVILLE — WarePack Self Storage LLC is the July Farmville Chamber of Commerce Merchant of the Month.

Housed in an old tobacco warehouse, WarePack Self Storage is a unique storage facility that allows customers to drive directly into the building to their storage unit and then out again.

The…

0711-MOM.jpg

July 16, 2018

Food Bank of the Albemarle announced that the Mobile Food Pantry serving western Bertie County will continue to provide nutritious food to those in need thanks to a $10,000 grant from The Franklin P. and Arthur W. Perdue Foundation and a donation of more than 21,000 pounds of chicken.

The Mobile…

070218-Food Bank of the Albemarle-Perdue-Grant-10K-Bertie-Mobile.jpg

July 16, 2018

The following new corporations in Pitt and neighboring counties filed July 5-11 with the N.C. Secretary of State’s office:

■ 1154 W Raleigh Blvd LLC, agent Khalid Almakaleh, 1154 W. Raleigh Blvd., Rocky Mount.

■ A & M Private Insurance Group Inc., agent Kelli R. Augustson, 2731…

203 stories in Workweek. Viewing 1 through 10.
«First Page   «Previous Page        
Page 1 of 21
        Next Page»   Last Page»