Juniper Pharmaceuticals Announces First Patient Enrolled In Phase II Study Of COL-1077 As An Acute-Use Anesthetic For Minimally-Invasive Gynecologic Procedures

June 15, 2015 |

4 min read

BOSTON, June 15, 2015 /PRNewswire/ -- Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (“Juniper”), a specialty pharmaceutical company focused on the development of therapeutics for women’s health, announced today the first patient has been enrolled in a Phase II clinical trial of COL-1077, a 10% lidocaine bioadhesive gel that is intended as an acute-use anesthetic during minimally invasive gynecologic procedures.

This clinical trial will evaluate the safety and efficacy of COL-1077 to reduce pain experienced during and after an endometrial biopsy. This common gynecological procedure helps in the diagnosis of conditions such as abnormal menstrual bleeding, pelvic tenderness, endometrial hyperplasia, and uterine cancer.

“An estimated five to six million minimally invasive gynecological procedures are performed annually in the U.S. alone, and the pain and discomfort patients experience when undergoing these procedures is real and significant. COL-1077 is potentially an elegant solution that we expect will effectively reduce women’s pain during gynecologic procedures and improve their clinical experience,” said Bridget Martell, M.A., M.D., Juniper’s Chief Medical Officer.

The multicenter clinical trial will study 150 patients undergoing pipelle-directed endometrial biopsy with tenaculum placement at 15 research sites across the United States. Through, random, double-blind assignment, the study will compare a single dose of COL-1077 (10% lidocaine bioadhesive gel) versus a placebo. COL-1077 is a sustained-released proprietary gel that is self-administered vaginally.

The study will assess the reduction in pain intensity during the endometrial biopsy and time points up to 24 hours after the procedure as compared to placebo. Safety assessments, use of “rescue” pain medications, and patient-related outcome measures, such as time to return to work following the biopsy will be also examined. Study results are expected in mid-2016.

Juniper’s research and development program is guided by its Scientific Advisory Board comprised of internationally renowned physicians and scientists including Dr. Robert Langer (Massachusetts Institute of Technology), Dr. William Crowley (Massachusetts General Hospital/Harvard Medical School), Dr. Ginger Constantine and Dr. Daniel Shames, under the chairmanship of Dr. Martyn Davies (University of Nottingham School of Pharmacy).

COL-1077 is the first in a series of value-creating drug compounds Juniper expects to advance into clinical development; announcement of the next product candidate is expected later this year. The specialty pharmaceutical company plans to use cash flow generated by its CRINONE^® franchise and service business to substantially fund its drug development.

About Juniper Pharmaceuticals

Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (formerly Columbia Laboratories) is a specialty pharmaceutical company focused on developing therapeutics that address unmet medical needs in women’s health. Juniper has a successful heritage in developing pharmaceutical products, including CRINONE^® 8% (progesterone gel), which is marketed by Actavis, Inc. in the U.S. and by Merck Serono S.A. in over 60 countries worldwide. The Company is leveraging in-house pharmaceutical development, clinical trial manufacturing, and analytical capabilities to advance an internal development pipeline, while also providing valuable consultative services to its pharmaceutical industry customers. Please visit www.juniperpharma.com for more information.

Juniper Pharmaceuticals and Juniper Pharma Services are trademarks of Juniper Pharmaceuticals, Inc., in the U.S. and EU.

CRINONE^®is a registered trademark of Actavis, Inc. in the U.S.

Forward Looking Statements

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” “should,” or similar expressions, and which are generally not historical in nature. These include all statements relating to the expected benefits of COL-1077 in reducing pain associated with minimally invasive gynecologic procedures and improve their clinical experience; anticipated timing to report study outcomes; and, Juniper’s business strategy and expected long-term value and future growth related thereto. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management’s current expectations and Juniper Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law. For a discussion of certain risks and uncertainties associated with Juniper Pharmaceuticals’ forward-looking statements, please review the Company’s reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2014.