Genitourinary Syndrome of Menopause (GSM)
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Overview

Menopause means a cessation of menstruation which is usually a gradual process wherein the production of estrogen declines and ultimately stops. GSM is a chronic and progressive syndrome that is underdiagnosed and without treatment will eventually be present in all women later in life, whether symptomatically or asymptomatically.

 

GSM includes not only genital symptoms associated with tissue loss but also urinary symptoms. As the production of estrogen declines and eventually ceases the vaginal tissues become thinner, drier, less elastic and fragile leading to increased exposure of the urethra to pathogenic bacteria. Compounding these factors is the absence of glycogen which leads to changes in the microbiome which is the leading cause of urinary tract infections and stress incontinence.

We have confirmed that the peripheral cannabinoid type 2 receptors (CB2) are highly expressed in vaginal tissue and that Immugen’s lead compound increases its thickness and consequently improves its structural integrity and barrier function which is impaired with the loss of estrogen around menopause. In addition, glycogen expression is restored which supports a healthier microbiome and overall healthier vaginal environment.

 

Vulvovaginal Atrophy

  • Vaginal dryness

  • Vaginal irritation/burning/itching

  • Pelvic pain or pressure

  • Exposure of urethral tissue from retraction of vaginal tissue 

Sexual Dysfunction  

  • Decreased lubrication during sexual activity

  • Painful sexual intercourse

  • Bleeding after sexual activity

  • Decreased arousal/loss of libido

  • Inability to orgasm

  • Impact interpersonal relations

Urinary (bladder) Dysfunction

  • Urinary urgency

  • Urinary incontinence (stress and urgency)

  • Recurrent urinary infections

  • Painful urination

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Incidence of Genitourinary Syndrome of Menopause (GSM)

Women are living 40% of their lives in the postmenopausal state, and the vast majority report symptomatic GSM.  It is estimated that 64 million women in the United States may be candidates for Immugen‘s lead compound. Globally, this could be as high as 1.1 billion women by 2025. Women become menopausal in three ways: through the gradual decline of estrogen levels that begins in the thirties; through surgical removal of both ovaries; and through chemotherapy, primarily due to adjuvant chemotherapy or tamoxifen for breast cancer before natural menopause. For those women experiencing immediate menopause, their symptoms can be more severe and debilitating.

 

Women experience menopause differently and often are unaware of GSM. One third of women report that their doctor is not comfortable talking about menopause and turn to friends and family for information. Social media channels often block discussion of products for adult products or services with the exception of family planning, contraception, and male libido-enhancing products.

 

 

Current Treatments

 

For nearly 100 years, the only treatment available for GSM has been estrogen replacement therapy (ERT) which is associated with significant health risks, particularly in older women and is specifically contraindicated in many breast cancer survivors.

 

Today, the primary treatment goal of GSM is to achieve the relief of symptoms at the cost of tens of billions of dollars annually. First-line treatments consist of non-hormonal therapies such as lubricants and moisturizers, or medicines and antibiotics to treat urinary symptoms.  Hormonal therapy with topical estrogen products applied vaginally is considered the “gold standard” though only a small percentage of women have embraced this treatment option. Concerns about the long-term effects of estrogen replacement (breast cancer and thromboembolic events, i.e., heart attacks and strokes) discourage both prescribing clinicians and women with GSM.

 

A comprehensive analysis of genomic data obtained from an NIH grant suggests that our lead compound will prove to be superior to estrogen and provide additional benefits through the activation of the peripheral endocannabinoid system that is expressed in every organ system of the body.

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