1 / 16

Estro Balance +10 Rx-W For Women HealTech INTERNATIONAL

Estro Balance +10 Rx-W For Women HealTech INTERNATIONAL. An Overlooked Market: Women’s Health .

tirzah
Download Presentation

Estro Balance +10 Rx-W For Women HealTech INTERNATIONAL

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Estro Balance+10 Rx-W For Women HealTech INTERNATIONAL

  2. An Overlooked Market: Women’s Health • “The group of US women between the ages of 45 and 64, estimated to grow to 41 million by 2010, is the richest, biggest-spending and most educated group of women ever.” — U.S. Department of Commerce • “With a baby boomer turning 50 every six seconds, millions of women are marching toward menopause—or are already in the midst of it. And catering to their health needs is a lucrative—but surprisingly untapped-business niche.” —Fortune magazine • “Women are using a variety of strategies to manage short-term disturbances during menopause. Those include healthy eating (85%), regular exercise (75%), vitamins (70%), calcium supplements(58%), relaxation techniques or yoga (25%), vaginal lubricants (22%), and plant estrogens (10%).” — A survey by the North American Menopause Society (NAMS)

  3. Premature Menopause • About 8% Women (US) stops having period before age 40 • Same symptoms as Menopause Peri-menopause • Average women go through this phase age 45~49 • Wildly fluctuating Estrogen Level • Same symptoms as Menopause Menopause • Estradiol level<50 pg/mL; FSH>50 mIU/mg; no period for >1 yr* • Average age for onset of menopause is 52 in US • Symptoms last 2~5 years, many more than 5 years Surgical Menopause • After Hysterectomy/Bilateral surgery * Definition: Dr. Joel Harglove, MD, Chairman, Vanderbilt Menopause Center, Nashville, TN Menopause Classification

  4. Physiological /Psychological Changes during Menopause • Hot flashes, Night sweats • Vaginal dryness & thinning of vaginal wall • Inelastic skin and dry eye, Depression, Mood swings, Insomnia, ‘Something-is-not-right-type of feeling’ Long Term Post-Menopausal Health Risks • Cardiovascular Diseases (CVD’s) • Osteoporosis Menopause Symptoms

  5. Hormone Replacement Therapy (HRT) – Prescription • Estrogen and/or Progesterone Therapy • Premarin® (Estrogen) and/or Prempro (Estrogen/Progestin) • Shown efficacy in reducing symptoms • Considered as Gold Standard for treating Menopausal symptoms till… • Women’s Health Initiative Study (WHI: 16,000 subjects) by NIH was halted in 2002 due to serious side effects ► Increased risk of Strokes (44%), Blood Clots (100%), CVD (29%) and Breast Cancer (26%) ► FDA required “Black Box Warning” for all Estrogen Products • Body of Long Term Data showed Risk outweighs Benefits • Experts recommend use of HRT at a lowest dose and for short duration(4 week) Natural Alternative to HRT (Menopausal Preparations) • Remifemi ® (black cohosh extract) • Isoflavon-rich diet (Soy products) Standard of Care for MenopauseSymptoms

  6. Black Cohosh • First developed in Germany, it has been prescription medication in EU • Numerous clinical studies showed strong efficacy, until recently, it is claimed to cause liver damage (Natural Products Insider, July 30, 2007) and last 360-subject NIH sponsored clinical trial showed no efficacy (Natural Products Insider, Jan. 15, 2007) Isoflavone (Soy) • Mixed Reviews on Efficacy: Asian diets are rich in isoflavone (miso soup, tofu, soy bean paste, bean sprouts), but symptoms manifest at the same rate as in Western countries • Shown to bind to estrogen receptors alpha & beta and may be carcinogenic (National Toxicology Program TR 545, NIH Publication No. 08-4430, Public Health Service, U.S. Department of Health and Human Services) Black Cohosh & Isoflavone (Soy)

  7. Estro Balance+10 Rx-W® has 3 herbal extracts • Phlomis umbrosa: Triterpene glycoside (Shanzhiside methyl ester) • Cynanchum wilfordii: Cinnamic acid, wilfoside & cyanuricoside • Angelica gigas Nakai: decursinol & decursin New Product Innovation: Estro Balance+10 Rx-W ®

  8. Science of Estro Balance+10 Rx-W • Herbal extracts screened out of 71 herbal extracts via non-reproductive tract target tissue response (E-screen test) • 3 herbal extracts were chosen: Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas Nakai • Proven Safety • About 400 years ofdocumented use in Korea and China as folk medicine • Registered as safe food ingredient in Korea Food Codex and in China • No increase of uterus weight in ovariectomized rat tests • Inhibition of proliferation of human breast cancer cell (MCF-7) • No binding Affinity to both Estrogen Receptor α and β, cancer-inhibitory • Safe: Acute & Multi-dose toxicity tests • Proven Efficacy in vitro, in vivo, and in 2 human group (Asian and American) clinical studies (one in Korea, one in USA)

  9. Estrogenicity • E-screen test: Screen herbal extracts for Estrogenicity • Synergetic Effects of 3 Constituent herbal extracts confirmed - Lee at al.. Lab. Anim. Res. 24(2): 167-172(2008) • Significantly improved in serum osteocalcin and FMBD in OVX rat • No change in weight, liver, kidney, and uterus weight in OVX rat FBMD Serum osteocalcin Uterus weight -Kim at al.. Kor. J Food Sci. Technol. 40(3): 316-320 (2008)

  10. Clinical study I (Asian) - Protocol Randomized Double-blind Placebo-controlled study ( SamSung Cheil Hospital, Seoul Korea) Estro Balance+10 Rx-W 12 months (May 2003-April 2004) Double-blinded Long Term Safety Evaluation 23 subjects in placebo group 24 active group Age>45 years old Diagnosis of menopausal syndromes (average age=54) Test material Dosing period Method Evaluation style Patients (n=47) Inclusion Criteria & &

  11. Clinical study I - Efficacy Climacteric Symptoms Femoral Bone MineralDensity Serum hGH Level Serum Osteocalcin Level Serum Alkaline Phosphatase Level Serum Triglyceride Level After 3 months OR=5.04 (95% C.I.=1.4-18.1) Fisher’s Exact Test 5 times better improvement than placebo with significance After 12 months 0.746±0.10 → 0.763±0.13 Significant improvement (P<0.05) After 12 months (ng/mL) 0.25±0.21 → 0.92±0.97 Significant improvement (P<0.05) After 12 months (ng/mL) 6.02±2.74 → 5.66±3.01 Significant improvement (P<0.05) After 12 months (IU/L) 73.35±21.02 → 60.42±14.87 (P<0.05) Significant improvement After 12 months (mg/dL) 119.1±54.72 → 92.16±49.94 Significant improvement (P<0.05)

  12. Clinical study II (American) – Protocol Randomized Double-blind, Placebo-controlled study ( Shady Canyon Medical Group, Irvine, CA) Estro Balance+10 Rx-W 3 months (2009-2010) Double-blind Long Term Safety Evaluation 32 subjects in placebo group 29 active group Age>42 years old Diagnosis of menopausal syndromes (average age=54) Test material Dosing period Method Evaluation style Patients (n=61) Inclusion Criteria & &

  13. Clinical Study II - Efficacy • Report (Kupperman Menopause Index & scores of vaginal dryness ) – Stearling IRB • The mean KMI scores were significantly reduced in MarsVenus Rx-W group from 29.45±7.39 at baseline to 13.62±7.61 at week 6 after and to 11.31±5.78 at week 12 while those were from 29.35±6.56 at baseline to 23.31±8.96 at week 6 after and to 23.66±7.68 at week 12 in the placebo group. The improvement was statistically significant in comparison with the two groups (p<0.01, t-test). • Safety: No significant changes in Osteocalcin, Alkaline Phosphatase, hGh, Cholesterol, L/H DL, Triglyceride, FSH, E2, Fasting Glucose, Weight, BMI, Protein, Albumin, and Serum Safety Factor

  14. Safety in 12 month human clinical study treatment • No serious adverse effects • No change in body weight • No change in blood pressure • No change in blood sugar • No change in cholesterol, LDL/HDL • No significant changes in E2 and FSH Clinical study - Safety

  15. Toxicology study on BOTH male & female rats • 500 mg/kg, 1000 mg/kg, 2000 mg/kg single dose • No mortality observed (MLD>2000 mg/kg) • No body weight changes observed • No toxicological, abnormal findings in necropsy observed • Slight diahrria at 2000 mg/kg, but all recovered next day Toxicology Study on BOTH male & female rats

  16. Key Findings of Estro Balance+10 Rx-W ® • Unlike Black Cohosh, it is antihepatotoxic or liver protective Filed to WHO, ① http://www.wpro.who.int/internet/files/pub/97/89.pdf, ② http://www.wpro.who.int/internet/files/pub/97/201.pdf • Unlike Soy, it proved to be not binding to Estrogen receptors alpha and beta Binding affinity of MarsVenus Rx-W to ER alpha and beta, College of Veterinary Medicine National University, Kang, et al. 2007 • Inhibitory effect of the proliferation of human breast cancer cell or MCF-7 ① College of Veterinary Medicine National University, Kang, et al. 2007 ② Jiang C, et al. Decursin and decursinol angelate inhibit estrogen-stimulated and estrogen-independent growth and survival of breast cancer cells. Breast Cancer Research. 9(6): R77 (2007), 6 Nov 2007 Key Findings of Estro Balance+10 Rx-W ®

More Related