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Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America

SALT LAKE CITY, Oct. 14, 2020 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (“SMSNA”). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes, and the rationale of using an oral testosterone therapy for men with COVID-19. Results from the previously completed dose validation (“DV”) study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.  The presentations will take place virtually on November 9, 2020 from 7:00 p.m.9:00 p.m. EST during Session 2 (Androgens and Ejaculation/Orgasm Disorders). 

https://www.smsna.org/V1/2020/program/scientific-program?where_person=44
https://www.smsna.org/V1/2020/program/scientific-program?where_person=42

“We know that while COVID-19 infection rates are comparable between men and women, men are developing severe symptoms and dying at a significant higher rate than women. Furthermore, men with comorbidities commonly associated with lower testosterone are at greater risk for severe disease and death,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc.  “The presentation on COVID-19 highlight key clinical evidences suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men. Based on the published data, the use of oral testosterone with the goal of achieving physiological testosterone levels should be evaluated in clinical trials of COVID-19.”

Dr. Anthony DelConte, Chief Medical Director of Lipocine further stated, “TLANDO will be the first oral testosterone for treatment hypogonadism without titration requirement. It is expected to be easy to prescribe and use.” Dr. DelConte added, “The SMSNA presentation on TLANDO highlights the key safety and efficacy data from multiple clinical studies supporting TLANDO’s ability to effectively restore testosterone levels in hypogonadal men without need for any dose adjustment.”

Is Oral Testosterone a Potential Treatment for COVID-19 in Men? (Benjamin J. Bruno et al)

The authors performed a literature search to understand the possible mechanisms and clinical evidence concerning testosterone levels in COVID-19 patients.  A recent clinical study investigating testosterone levels in men with COVID-19 found 80% of men who died due to COVID-19 had low total or bioavailable testosterone levels at the time of hospital admission. Those with severe Acute Respiratory Distress Syndrome (“ARDS”) had acutely depressed total testosterone compared to patients who did not exhibit severe ARDS. The mean total testosterone levels for men who required invasive ventilation was 29 ng/dL (normal range ~300-1100 ng/dL), whereas those who were discharged from the ICU had mean total T of 254 ng/dL at the time of ICU admission.

In comparison to other routes of testosterone administration, oral testosterone therapy may be the most convenient and suitable for acute treatment of COVID-19 in

SEngine Precision Medicine to Present at Society of Functional Precision Medicine Virtual …

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

SEATTLE, Oct. 13, 2020 (GLOBE NEWSWIRE) — SEnginePrecision Medicine, a precision oncology company revolutionizing cancer diagnostics and drug discovery by pre-testing drugs on patient-derived tumor organoids, today announced that Chief Medical Officer Astrid L. Margossian, MD, PhD, will present at the Society for Functional Precision Medicine (SFPM) Virtual Monthly Seminar on October 14th at 11:30 am ET.

Dr. Margossian is leading SEngine’s clinical validation initiatives for the PARIS® Test, a CLIA certified cancer organoid based drug sensitivity test for all solid tumors. The presentation is entitled, “Predictive Clinical Value of a CLIA-Approved Organoid Based Drug Sensitivity Test,” and will highlight the data on the PARIS® Test, recently presented at the ASCO 2020 and ACCR 2020 annual meetings, inclusive of organoids sensitivity results, showing clinical correlation with genomics and previous clinical treatments. Registration for the live event is available for free at https://www.sfpm.io/seminars.php.

SFPM’s virtual monthly seminar brings together distinguished guest speakers and through interactive panel discussions and Q&A sessions focuses on these key topics:

  • Demonstrating the clinical utility of functional precision medicine testing
  • Implementing functional testing in precision medicine clinical trials
  • Accelerating the application of functional testing
  • Addressing stakeholder, educational and investment challenges for functional precision medicine

About PARIS® Test
The CLIA certified PARIS® Test is based on the capability to propagate patient-specific cancer tissue as organoids ex vivo and is applicable to all solid tumors including colon, breast, lung, ovarian and pancreatic cancer. Organoids are cancer-derived cells grown in 3D outside the body, which maintain the functionality of the original tumor as well as its genomic characteristics. For cancers where the path is not clear, such as many metastatic and recurrent cancers, the PARIS test provides crucial information to the treating physicians to match the right drug to the right patient.

About SEngine Precision Medicine
SEngine Precision Medicine Inc. is a precision oncology company revolutionizing cancer diagnostics and therapies by pre-testing drugs on patient-derived organoids grown ex-vivo utilizing patient specific tumor cells. As a spin-out from the world-renowned Fred Hutchinson Cancer Research Center, SEngine is leveraging over two decades of R&D in diagnostics and drug discovery. The Company is commercializing the PARIS® Test, a next generation diagnostic test that predicts drug responses integrating knowledge of cancer genomics with organoids, robotics, and AI-driven computational tools. SEngine’s CLIA certified PARIS® Test generates predictive drug sensitivity reports for patients with solid tumors. SEngine is also pursuing drug discovery via strategic collaborations with biopharmaceutical / pharma companies leveraging its precision oncology platform.

Discover more at SengineMedicine.com and follow the latest news from SEngine on Twitter at @SEngineMedicine and on LinkedIn.

Contact:
Stephanie Carrington
[email protected]
646-277-1282

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Florida Gov. DeSantis explains his handling of coronavirus: ‘We wanted society to function’

“You can’t kneecap your own society and think you’re going to successfully handle a pandemic,” Florida Gov. Ron DeSantis told Fox News’ “Life, Liberty & Levin” in an interview airing Sunday night.

The Republican DeSantis has been harshly criticized by the mainstream media for his handling of COVID-19. The governor declined to issue a statewide face mask mandate and lifted restrictions on bars and movie theaters in early June. Last month, DeSantis lifted all state capacity restrictions on bars and restaurants.

“What we did, Mark, was really three things,” DeSantis told host Mark Levin. “One is protect those who are the most vulnerable to the disease, which is our elderly population, and focus that protection there rather than trying to suppress society as a whole. Second thing is, we want to make sure that our hospital system had what they needed in terms of PPE, medication, testing, and we were able to do that.

“But then third, and I think this is really important, we wanted society to function. You can’t burn down the village in order to save it … So if you look now, Florida’s open for business. We have everything — like theme parks, all that have been open for months. And we have kids in school in person. Parents have the option to opt for virtual [learning] if they want, but they have the in-person [option], which is very, very important.”

WATCH ‘LIFE, LIBERTY & LEVIN’ SUNDAYS AT 8 PM ET ON FOX NEWS CHANNEL

As of Saturday, Florida (population: 21.5 million) had recorded 15,186 deaths from COVID-19, compared to 32,875 in New York state (population: 19.5 million).

“One of the things we did in the middle of March is we prohibited hospitals from discharging ill patients with coronavirus back into nursing homes because many of them were not equipped to handle that,” DeSantis explained. “And so what we did instead is we established a lot of COVID-only nursing units throughout the state. So if you had someone test positive in a nursing home, but they weren’t ill enough to need hospitalization, they had a safe place to be isolated in.”

DESANTIS: CLOSING SCHOOL IN SPRING MIGHT HAVE BEEN ONE OF NATION’S ‘BIGGEST PUBLIC HEALTH MISTAKES’

According to the federal Centers for Medicare & Medicaid Services (CMS), 3,202 Florida nursing home residents had died of coronavirus as of Sept. 27. It’s unclear how many New York state nursing home residents have died of the illness because the state does not count residents who died in hospitals as part of the total. However, an Associated Press report from August suggested the number could go as high as 11,000.

“One of the problems that we had in terms of some of the restrictions with nursing homes was we stopped the visitation early on,” DeSantis recalled. “We didn’t want the disease to get in. I think most of the people wanted that done. But after months of this, you start to see loneliness and despair creep in … We