Sábado 21 de Octubre 2017

Phase 3 Trial Data Show Use of SpaceOAR® Hydrogel Helps Maintain Erectile Function Following Prostate Cancer Radiation Treatment

Lower penile bulb radiation dose may be associated with ability to
maintain sexual function and potency

BEDFORD, Mass.–(BUSINESS WIRE)–Augmenix, Inc., a medical technology company that develops,
manufactures, and sells proprietary absorbable hydrogels that separate
and protect organs at risk during radiotherapy announced a newly
published analysis from the company’s Phase 3 SpaceOAR System clinical
trial. An abstract accepted at the ASCO 2017 Genitourinary Cancer
Symposium showed that SpaceOAR hydrogel, placed between the prostate and
rectum in men undergoing prostate radiotherapy, helps men maintain
sexual function and potency following intensity modulated radiation
therapy (IMRT).


Many studies have shown a correlation between radiation dose to the
penile bulb, a structure at the base of the penis, and post-radiotherapy
impotence. In the SpaceOAR System trial the median radiation dose to the
penile bulb was reduced by 49% in SpaceOAR treated patients (21 Gy for
Control vs 11 Gy for SpaceOAR treated, p=0.036). Among men who were
potent at baseline, the analysis showed that SpaceOAR treated men were
better able to maintain erections sufficient for intercourse through 3
years of follow-up (p=0.03). Of the men treated with SpaceOAR, 66.7%
were able to have erections sufficient for intercourse at 3 years
compared to 37.5% in the Control arm, a 77.8% improvement.

“Loss of sexual function represents one of the most devastating
consequences of radiation therapy for prostate cancer,” said Dr. Daniel
Hamstra, MD, PhD, radiation oncologist at the Texas Center for Proton
Therapy. “These results show that by reducing the levels of radiation
that reach the penile bulb the treatment with SpaceOAR may be able to
help more men maintain sexual function and potency after treatment.”

Radiation therapy in the treatment of prostate cancer can cause
unintended radiation injury to adjacent healthy tissue. Injury can
increase the risk of bowel, urinary and sexual symptoms that can affect
patient health and quality of life. In the study treatment group, men
were injected with Space OAR System in the space between the prostate
and rectum prior to administration of radiation therapy. Injected as a
liquid, it solidifies into a soft gel that temporarily pushes the rectal
wall away from the prostate. The hydrogel remains stable for three
months and then liquefies and is completely absorbed by the body after
radiation treatment is completed.

“Our phase 3 clinical trial previously demonstrated that SpaceOAR offers
a significant benefit in reducing the risk of rectal complications and
damage associated with radiation therapy in the treatment of prostate
cancer,” said John Pedersen, CEO of Augmenix. “The important findings
from this new analysis indicate that SpaceOAR could also help to reduce
the risk that radiation therapy could adversely affect sexual
performance for millions of men treated for prostate cancer in the years
ahead.”

About Augmenix, Inc.
Augmenix, Inc. is a privately held company
based in the Boston area and focused on the development and
commercialization of radiation oncology products using its proprietary
hydrogel technology. Focusing initially on protection during prostate
radiation therapy, Augmenix next-generation products will address
spacing and marking applications throughout the body to improve
radiotherapy and interventional oncology procedure outcomes. The
company’s lead product, SpaceOAR System, is FDA cleared and is currently
being used in the majority of leading cancer centers in the United
States. It is also CE marked, approved in Australia and licensed in
Canada. SpaceOAR is a registered trademark of Augmenix, Inc. More
information about Augmenix and the SpaceOAR System can be found at http://www.Augmenix.com.

Contacts

Augmenix
Eileen Gardner, RN, 781-902-1625
egardner@augmenix.com