MENOGENIX, INC. — Department of Health and Human Services SBIR Phase I: NIA

Description

One of the most common and distressing symptoms of menopause are hot flashesHot flashes and related symptoms represent a significant unmetworldwidehealthcare neednot only in women after surgical or natural menopausebut also in breast and prostate cancer patients undergoing hormone suppression or ablationHot flashes occur inof women undergoing natural menopause and approximatelymillion individuals worldwide seek therapy each yearA hot flash is a sudden feeling of warmth that is generally most intense over the faceneck and chest as well as peripheral vasodilation leading to flushreddening of the skinThe duration is variable but averages aboutminutesIt is often accompanied by sweatingAlthough not lifethreateninghot flashes can have a detrimental effect on a womanandapos s functional ability and quality of lifeThe physiological mechanisms leading to a hot flash episode are not knownSimilarlyit is not known how the decreasing hormone levels that occur during the menopause transition lead to increased incidence of hot flashes and related symptomsThe only approved therapies for hot flashes are hormone therapyHTand a low dose form of paroxetinean anti depressantHT is associated with severe health risks including development of heart diseasecancerstroke and dementiaParoxetine use is associated with suicidal thoughts and ideation as well as addictionWhile there are no other FDA approved alternativesphysicians often prescribe other anti depressantsanti psychotic agents and pain medicationsall of which have significant side effectsSeeking less dangerous alternativesmany women turn to alternative therapies including nutraceuticals and acupuncture but none of these have proven to be effective in placebo controlled trialsAn effectivenon hormonalnon anti depressanttreatment for hot flashes and related vasomotor symptoms would be a welcomenovel and useful treatment modalityMenoGeniX is repurposing a naturally occurring human protein called granulocyte colony stimulating factorG CSFto treat hot flashes based on placebo controlled phaseclinical trial data which showed that a single administration of G CSF can lead to a rapid and significant reduction in hot flash frequency and severity in women with naturally occurring and surgically induced menopauseWomen with surgically induced menopause as well as African American women responded especially wellIn this phaseSBIR applicationMenoGeniX is proposing a placebocontrolleddose range findingphasea clinical trial to evaluate the efficacy and safety of G CSF administered monthly to treat menopausal hot flashesWith a good safety record when used chronically to treat neutropeniaG CSF may represent a valuable alternative for women with bothersomemoderate to severe hot flashes who are unwilling or unable to take HT or anti depressants Hot flashes occur inof women undergoing naturally occurringas well as surgicallyand chemotherapy induced menopause with approximatelymillion individuals worldwide seeking therapy each yearThe only FDA approved therapies are hormone therapy and an anti depressant called paroxetineboth of which have life threatening side effects which discourage their useMenoGeniX is developing a naturally occurring human protein called G CSF to treat hot flashesG CSF may represent a valuable alternative for women with bothersomemoderate to severe hot flashes who are unwilling or unable to take HT or antidepressants