{"id":7495,"date":"2017-01-24T13:47:24","date_gmt":"2017-01-24T20:47:24","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=7495"},"modified":"2021-09-07T17:56:54","modified_gmt":"2021-09-07T23:56:54","slug":"startup-aims-to-cool-hot-flashes","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/startup-aims-to-cool-hot-flashes\/","title":{"rendered":"Startup aims to cool hot flashes"},"content":{"rendered":"
<\/div>

Debra Duke had found herself among the two-thirds or more of menopausal women who get hot flashes. Several times a day, she abruptly heated up as if she\u2019d been dropped on some invisible skillet.<\/p>\n

\"Debra
Debra Duke founded MenoGeniX to bring a drug the FDA originally approved\u00a0in 1991 to market — this time to help women deal with menopausal hot flashes.<\/figcaption><\/figure>\n

Hot flashes are uncomfortable, they\u2019re disruptive, and they are pervasive, affecting some 10 million women in the United States alone on any given day. As of 2008, when Duke noted that her hot flashes had quite suddenly dissipated, there was a single U.S. Food and Drug Administration-approved drug to treat hot flashes: hormone replacement therapy.<\/p>\n

But Duke wasn\u2019t taking hormones or anything else to ice her hot flashes. Rather, during a workup, the late University of Colorado School of Medicine oncologist Fred Kolhouse, MD, had diagnosed mild neutropenia \u2013 a deficit of white blood cells called neutrophils \u2013 and prescribed granulocyte colony-stimulating factor (G-CSF) to stimulate her body\u2019s neutrophil production.<\/p>\n

G-CSF had been FDA-approved since 1991, when Amgen brought the drug Neupogen to market. Countless women, many of them coming off cancer therapy, have taken it since. Some may have noticed their hot flashes cooling as a result. Only Duke acted on that insight \u2013 in her case, launching a company, MenoGeniX<\/a>, that aims to help women everywhere douse their hot flashes with a customized form of G-CSF.<\/p>\n

 <\/p>\n

So far, so good: an initial clinical trial in 30 women provided supportive data that G-CSF could reduce hot-flash frequency and severity in other women. Duke is now working on funding for a much larger trial that she aims to launch in 2017.<\/p>\n

Serendipity<\/strong><\/p>\n

Sit down with Duke in the Fitzsimons Bioscience Park Center\u2019s main conference room and she\u2019ll tell you right away that the story isn\u2019t about her, and that MenoGeniX wouldn\u2019t have gotten far without help ranging from her spouse and several other CU School of Medicine faculty serving as advisors. And that\u2019s a fact.<\/p>\n

Her spouse is Richard Duke, PhD, a tenured CU School of Medicine immuno-oncologist, serial biotech entrepreneur, and founder of the Colorado Institute for Drug, Device and Diagnostic Development (CID4). When Debra mentioned to Rick, \u201cYou know, I don\u2019t know if it has anything to do with the shot [of G-CSF], but my hot flashes seem to be going away,\u201d he answered not with an absent, \u201cThat\u2019s nice, Debra.\u201d Rather, Rick suggested they sit down with a well-known life science patent attorney, Gladys Monroy, PhD, which they did. In time that yielded patents now issued and pending across the world\u2019s major markets.<\/p>\n

\"Nanette
Nanette Santoro, MD, chair of the CU School of Medicine\u2019s Department of Obstetrics and Gynecology, heads the MenoGeniX Scientific Advisory Board.<\/figcaption><\/figure>\n

The Dukes had recognized that, despite Amgen\u2019s holding the patent on the composition of synthetic G-CSF (since expired, in 2013), one can acquire a patent for a label expansion \u2013 that is, a new clinical use for someone else\u2019s drug. In this case, they did that for G-CSF as it relates to menopause, and in 2012 they founded MenoGeniX to turn that intellectual property into a real therapy. CU has successfully commercialized other therapies this way, including Botox to treat overactive bladder and the Zostavax vaccine to prevent shingles in adults, according to Richard Duke.<\/p>\n

Debra Duke raised $500,000 from angel investors and poured it into that first pilot trial \u2013 a randomized, placebo-controlled, double-blind clinical trial involving 30 women with naturally occurring or surgically induced menopause. CU School of Medicine OB\/GYN and women\u2019s health physician Maryam Guiahi, MD, MSc, who practices at University of Colorado Hospital, led the effort.<\/p>\n

While MenoGeniX is keeping the details quiet pending publication, the subjects who received a single injection of G-CSF reported a significant reduction in their hot flash frequency and severity within two weeks as compared to those who received a placebo. The two subgroups of women in the study that have been reported to have the most severe hot flashes \u2013 African American women and women with surgically induced menopause \u2013 appeared to respond particularly well to G-CSF vs. placebo. Surgically induced menopause tends to bring worse hot flashes \u2013 and for many such patients, who like Angelina Jolie have had their ovaries removed to lower their risk of developing breast and ovarian cancer, hormone replacement therapy isn\u2019t an option.<\/p>\n

Should the initial clinical trial\u2019s numbers hold up in future trials, they would compare favorably to those of hormone replacement therapy and outclass those of Brisdelle, the second FDA-approved (in 2013) therapy for hot flashes, which is a weaker version of the antidepressants Paxil and Pexeva. In addition, Guiahi also had patients fill out menopause-related quality of life questionnaires such as the Hot Flash Daily Related Interference Scale and the Fatigue Severity Score. Patients on G-CSF reported much higher scores than those on the placebo, Duke said, suggesting that G-CSF is having a positive effect on their day-to-day lives.<\/p>\n

Help in high places<\/strong><\/p>\n

MenoGeniX has harnessed CU School of Medicine expertise beyond that of her husband and Guiahi. Advisors include CU endocrinologist Margaret Wierman, MD, and medical oncologist William Robinson, MD, PhD, whose work with G-CSF harkens back to the discovery of the first human colony-stimulating factors in the 1960s. Nanette Santoro, MD<\/a>, chair of the CU School of Medicine\u2019s Department of Obstetrics and Gynecology, heads up the startup\u2019s scientific advisory board. All practice at UCH.<\/p>\n

Santoro says the MenoGeniX phase 1B trial results were \u201ca signal that it\u2019s effective. Is it worth looking into further? I think the answer is \u2018yes,\u2019 that it should be worked up more carefully,\u201d Santoro said.<\/p>\n

She added that while she doesn\u2019t hesitate to prescribe hormone replacement therapy for women close to menopause and considers it safe, she recognizes that \u201clots of women have a fear and loathing of hormones\u201d stoked by research that has linked long-term hormone replacement therapy to breast cancer, heart disease, stroke and blood clots. Either way, Santoro said, \u201cWe really are badly in need of alternatives.\u201d<\/p>\n

As to why G-CSF seems to quell hot flashes as it prods white blood cell production, no one can say. Santoro says the vasodilation (opening of blood vessels) that brings hot flashes is probably a central nervous system phenomenon. That the root cause remains a mystery explains why serendipitous discoveries have been the norm in formal hot flash therapy. Brisdelle, she says, came about when Mayo Clinic oncologists noted that breast cancer patients taking the antidepressant Paxil reported a slight improvement in their hot flashes. It was much the same with the anti-seizure medication gabapentin, whose use for hot flashes was also discovered anecdotally in a woman taking the drug to treat migraine. In the case of gabapentin, though, an FDA advisory panel recommended against<\/a> the drug\u2019s approval in 2013.<\/p>\n

To move G-CSF a big step closer to FDA approval, Duke is planning a phase 2 clinical trial to test repeat administration of the drug, dosing, and durability \u2013 that is, what\u2019s the right amount of G-CSF to give women and how often to safely suppress hot flashes in otherwise healthy women. With 300 patients expected to take part, it will be a multimillion-dollar affair, for which Duke is rounding up funding and looking for partners. A much larger phase 3 trial would cost even more. By that point, she\u2019s hoping a major biopharmaceutical firm, one capable of bringing the drug to a big market in dire need of relief, can take the reins.<\/p>\n

For now, the work to build MenoGeniX, she said, \u201chas basically taken over my life. And that\u2019s okay, because what can be more important?<\/p>\n

\u201cHot flashes affect peoples\u2019 lives,\u201d Duke said. \u201cYou go on the internet and what do you see? People are talking about yoga and teas and Chinese herbs and massages. Women are suffering and deserve more alternatives.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

Debra Duke had found herself among the two-thirds or more of menopausal women who get hot flashes. Several times a day, she abruptly heated up as if she\u2019d been dropped on some invisible skillet. Hot flashes are uncomfortable, they\u2019re disruptive, and they are pervasive, affecting some 10 million women in the United States alone on […]<\/p>\n","protected":false},"author":23,"featured_media":7496,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[5],"tags":[335,80,263,212,23],"class_list":["post-7495","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-care","tag-anschutz-medical-campus","tag-denver-broncos","tag-university-of-colorado-hospital","tag-womens-care","tag-womens-health"],"acf":[],"yoast_head":"\nStartup aims to cool hot flashes - UCHealth Today<\/title>\n<meta name=\"description\" content=\"Debra Duke had found herself among the two-thirds or more of menopausal women who get hot flashes. 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