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My 'sinus Infection' Turned Out To Be A One In A Million Nasal Cancer At Just 28 - And Doctors Had To Cut My Eye Out To Save Me
A 28 year-old California woman has described the shock of being diagnosed with a deadly sinus cancer that affects fewer than one in a million people - and led to the removal of her right eye.
The 'golf ball-sized tumor', which had spread throughout her face, was first mistaken for a sinus infection by the woman's doctors.
Annika, who posts about her condition on TikTok, woke up one morning in 2023 and noticed that the inner corner of her right eye was sore.
While she at first thought nothing of it, by the time the evening rolled around, 'my face started to really, really hurt on the right side,' she said in a video.
The next day, her face swelled around her right eye, prompting her to seek medical attention.
Annika, 28, was diagnosed with a rare nasal cancer after doctors mistook it for a sinus infection. She initially went to the hospital with swelling around her eye
Annika was diagnosed with stage four sinonasal carcinoma SMARCB1 (INI-deficient), which had spread to her face, lungs, and lymph nodes
A CT scan in the emergency room showed inflammation around Annika's eye, leading doctors to suspect she had a sinus infection. The swelling reduced over a few days, only for it to return about a week later.
During Annika's second visit to the emergency room, 'the doctor felt my eye and he was like, "This doesn't feel like a sinus infection."'
This time, a CT scan revealed a mass 'about the size of a golf ball,' which 'wasn't there three weeks ago.'
At just 27, Annika was diagnosed with stage four sinonasal carcinoma SMARCB1, which had spread to her face, lungs, and lymph nodes.
Sinonasal cancers begin in the nasal cavity, which is just behind and around the sides of the nose. Several forms of cancer can grow there, but SMARCB1 is considered to be extremely rare.
According to research from the NIH, fewer than 200 cases have been reported in medical literature. The study also noted that it makes up just one percent of all head and neck cancers.
Much is still unknown about the prognosis, but the NIH states that most patients survive just two to four years after diagnosis, and 'later stage tumors are associated with a worse prognosis.'
Symptoms include nasal obstructions, headaches, protrusion of the eyeball, and nosebleeds.
Annika said that she started chemo 'almost immediately,' which lasted for nine weeks.
However, she saw little improvement and went in for surgery in December 2023.
'They also had to take surrounding tissue, which included my right eye,' she said in another TikTok video.
'So what you see now is essentially a piece of my thigh kind of filling that gap.'
'I have been told that it will kind of go down, but it's also a different color because my thigh was a lot tanner.'
Annika is currently on an experimental treatment plan that includes chemotherapy and immunotherapy to slow the spread of her disease.
Though the statistics are grim, Annika has admitted that she doesn't know what her prognosis looks like.
'I know it's not great,' she said.
'I know when you read about my cancer it's "rare, aggressive, poor prognosis," but no doctor has sat me down and been like "This is how long you have to live."'
FDA Approves New Sinusitis Treatment Without Nasal Polyps From Optinose
YARDLEY, Pa. - Optinose (NASDAQ:), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved XHANCE (fluticasone propionate) nasal spray for treating chronic rhinosinusitis without nasal polyps in patients 18 years and older.
Chronic sinusitis is a prevalent condition affecting around 30 million adults in the U.S., often leading to a significant number of outpatient visits and antibiotic prescriptions. Prior to this approval, no medication had been authorized specifically for the treatment of chronic sinusitis patients without nasal polyps.
The FDA's decision was based on the ReOpen program, which comprised two large, randomized, double-blind, placebo-controlled Phase 3 trials. These trials demonstrated a statistically significant reduction in symptoms and sinus inflammation, as well as a decrease in acute exacerbations often resulting in antibiotic use.
XHANCE utilizes the proprietary Exhalation Delivery System to deliver fluticasone, a proven steroid, to inflamed areas within the nasal cavity and sinuses that are not typically reached by standard nasal sprays.
The safety profile of XHANCE in the ReOpen trials was generally consistent with its currently labeled safety profile, with the most common adverse reactions being epistaxis, headache, and nasopharyngitis.
Dr. Rick Chandra, a Professor of Otolaryngology at Vanderbilt University, highlighted the importance of this approval, stating that until now, therapies used to alleviate symptoms in these patients were unproven. XHANCE's effectiveness in delivering the steroid to the targeted areas of inflammation offers a new treatment option for chronic sinusitis patients.
Optinose CEO, Ramy Mahmoud, expressed optimism about XHANCE becoming part of the standard of care for chronic sinusitis treatment. He also emphasized the burden of the disease on patients, many of whom report frustration with symptom relief when using standard-delivery nasal steroid sprays.
3rd party Ad. Not an offer or recommendation by Investing.Com. See disclosure here or remove ads .The approval of XHANCE expands its indications, as it was previously approved for treating chronic rhinosinusitis with nasal polyps. This new indication offers a potential solution for the majority of chronic sinusitis patients who do not have nasal polyps.
This article is based on a press release statement from Optinose, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Optinose Announces $55 Million Registered Direct Offering
Led by Nantahala Capital and The D. E. Shaw Group with participation from existing and new investors
Post-offering cash balance of ~$100 million expected to fund operating plan through 2025
Company expects XHANCE net revenues to be between $85 to $95 million for full year 2024
YARDLEY, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that it has entered into agreements for the sale of approximately $55 million of its common stock and pre-funded common stock warrants to a group of existing and new institutional investors in a registered direct offering.
In the registered direct offering, the Company is selling 31,800,000 shares of its common stock at a price of $1.00 per share, representing the average closing price of the Company's common stock on the Nasdaq Global Select Market for the five trading days immediately preceding the signing of the binding agreement prior to market close on May 8, 2024. In addition, the Company is selling to certain investors pre-funded warrants to purchase up to an aggregate of 23,700,000 shares of its common stock at a price of $0.999 per each pre-funded warrant, which represents the per share offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The gross proceeds from the offering are expected to be approximately $55 million, before deducting estimated offering expenses. The registered direct offering is expected to close on or about May 10, 2024, subject to the satisfaction of customary closing conditions.
The financing is being led by Nantahala Capital and the D. E. Shaw group with participation from multiple other new and existing healthcare focused investors.
"We appreciate the support of this group of new and existing investors," said Ramy Mahmoud, MD, MPH, CEO of Optinose. "The landmark efficacy evidence from two controlled trials, followed by the first-ever FDA approval of XHANCE as a prescription treatment for chronic rhinosinusitis without nasal polyps is a strong foundation for pursuing future growth opportunities. We expect the post-offering cash and cash equivalents of approximately $100 million to fund operations and debt service obligations through 2025. With a strengthened financial footing, our team looks forward to helping millions of patients suffering from chronic sinusitis by making the first effective prescription treatment broadly available. Right now, our launch is focused on a specialty prescriber audience, and we expect XHANCE net revenues to be between $85 to $95 million for full year 2024," he concluded.
The securities described above were offered pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on August 10, 2023 and declared effective by the SEC on August 17, 2023 (File No. 333-273873). The securities are being offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement relating to the offering was filed with the SEC on May 9, 2024 and is available on the SEC's website at www.Sec.Gov. A final prospectus supplement containing additional information relating to the offering, will be filed with the SEC and will be available on the SEC's website at www.Sec.Gov.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About OptinoseOptinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists.
About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older.
IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS:
DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.G., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.
Please see full Prescribing Information, including Instructions for Use
Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the timing and closing of the offering;, the potential benefits of XHANCE for the treatment of chronic sinusitis (also referred to as "chronic rhinosinusitis" and "chronic rhinosinusitis without nasal polyps"); the Company's commercial plans and expectations for XHANCE; future growth opportunities; the Company's expectation for full year 2024 XHANCE net revenues to be between $85 to $95 million; the Company's expectation that its post-offering cash and cash equivalents of ~$100 million will be sufficient to fund its operations and debt service obligations (operating plan) through 2025; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies and other future events. Forward-looking statements are based upon management's current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, stock price volatility; physician and patient acceptance of XHANCE for its new indication; the Company's ability to maintain adequate third-party reimbursement for XHANCE (including for its new indication); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company's ability to efficiently generate XHANCE prescriptions and net revenues; unexpected costs and expenses; the Company's ability to achieve its financial guidance; potential for varying interpretation of the clinical trial results of XHANCE; the Company's ability to comply with the covenants and other terms of the Amended and Restated Pharmakon Note Purchase Agreement; risks and uncertainties relating to intellectual property; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company's most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission which are available at www.Sec.Gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor ContactJonathan Neelyjonathan.Neely@optinose.Com267.521.0531
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