Dr. Tanya Petrossian was 33, working her dream job as vice president of products in New York, when her normally mild allergies were suddenly causing her to go into anaphylactic shock.
She visited the hospital three times, where doctors either minimized it as inflammation or had no answers.
It took 10 doctors before she finally received a diagnosis: ovarian cancer.
In actuality, it was stage 4 endometriosis, a condition affecting an estimated one in 10 reproductive-age girls and women but often misunderstood and overlooked.
“A lot of people are dismissed and have to go to 10 doctors, like myself,” Petrossian told the Business Journal.
This experience drove her to found Irvine-based EndoCyclic Therapeutics to pioneer the world’s first non-hormonal therapeutic for endometriosis.
After more than a decade of development, the company reached a pivotal milestone last month when the FDA cleared its Investigational New Drug (IND) application for its targeted peptide therapy, designed to eliminate endometriosis lesions and associated symptoms. Endometriosis lesions are tissue similar to uterine lining that grows outside of the uterus, causing chronic pain, scarring and infertility.
“IND clearance is a big milestone for any company, but for us in the endometriosis world, it’s absolutely huge,” Petrossian said. “We have a clinical product that’s going into clinical trials that’s actually addressing a disease that people historically thought there was just no way.”
With IND clearance, the company said it plans to initiate a Phase 1 clinical trial in healthy pre-menopausal women of reproductive age. No timeline has been disclosed yet for when trials may begin.
Company Tackles Overlooked Disease
Petrossian’s background is in biochemistry, molecular biology and bioinformatics.
Early in her career, she worked as a research intern at Allergan in the preclinical research department for Botox. After earning her doctorate in biochemistry and molecular biology at UCLA, Petrossian received fellowship training at Memorial Sloan Kettering Cancer Center.
“I feel like, from an educational standpoint, I have the perfect background to address this disease,” Petrossian said.
Despite affecting an estimated 190 million women globally and being the leading cause of infertility, the average time to diagnose endometriosis takes between seven and 10 years.
There are several reasons for the delay, including normalization of menstrual pain and misdiagnosis for other conditions with overlapping symptoms.
One National Institutes of Health study found that 75% of women reported being misdiagnosed with another physical or mental health condition before receiving an accurate diagnosis.
There is no cure for endometriosis, and it is currently managed through hormonal therapies such as birth control to reduce estrogen levels.
When Petrossian found out that she had endometriosis, she said that hormones caused her migraines and terrible pain. She later found that one symptom of endometriosis is resistance to progesterone, found in birth control.
“What happens is there’s a causation and correlation, and sometimes that gets mixed up,” Petrossian said.
What her company aims to do is address the root cause.
They sought to identify which signals were misbehaving in endometriosis cells, screened 10 trillion peptides and developed a therapy that’s said to be absorbed only by diseased tissue.
Imaging Agent for Endometriosis
A few years ago, the company created a second product based on its current peptide platform.
It developed FemLUNA, a targeted endometriosis imaging diagnostic as a non-invasive alternative to laparoscopy surgery, the current gold standard for diagnosis.
Conventional imaging can’t visualize certain subtypes of endometriotic lesions, especially superficial lesions, which account for more than 80% of lesions and can still cause significant pain. Its diagnostic accuracy also varies by anatomical location and operator expertise. FemLUNA, on the other hand, has the potential to detect all lesion subtypes, even small lesions at the earliest stage of disease, the company said.
“Together with these two products, we think we are going to completely transform endometriosis care,” Petrossian said.
EndoCyclic is also exploring other applications, including cancer and other women’s health indications, such as adenomyosis, which Petrossian calls “endometriosis’ cousin.”
The condition occurs when tissue grows within the wall of the uterus, causing it to thicken, enlarge and bleed during menstruation.
