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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

NBC Says Trump Will Hold Town Hall Meeting Thursday, Competing Against Biden

President Trump may not be debating Joseph R. Biden Jr. on the same stage on Thursday night as originally planned. But the two candidates will still face off head-to-head.

NBC News confirmed on Wednesday that it would broadcast a prime-time town-hall-style event with Mr. Trump from Miami on Thursday at 8 p.m. Eastern, with the president fielding questions from Florida voters.

The event will directly overlap with an already-scheduled ABC televised town-hall meeting with Mr. Biden in Philadelphia, which will begin at the same time.

Mr. Biden’s town hall has been on the books since last week, after Mr. Trump, who had recently contracted the coronavirus, rejected plans to convert the second formal presidential debate into a virtual matchup; the debate was eventually canceled.

The NBC event, to be moderated by the “Today” show host Savannah Guthrie, had been contingent on the Trump campaign providing independent proof that the president would not pose a safety risk to the other participants — including NBC crew members, voters and Ms. Guthrie herself.

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As late as Tuesday afternoon, NBC executives were waiting for that proof, but the network determined late Tuesday that it would be comfortable moving forward, according to two people familiar with the planning.

On Wednesday’s “Today” show, the NBC anchor Craig Melvin said the town hall would occur “in accordance with the guidelines set forth by health officials” and proffered a statement from Clifford Lane, a clinical director at the National Institutes of Health.

In the statement, Dr. Lane said he had reviewed medical data about Mr. Trump’s condition, including a so-called P.C.R. test — a widely used diagnostic test for the coronavirus that is considered more reliable than a rapid antigen test — that the N.I.H. “collected and analyzed” on Tuesday. Dr. Lane concluded “with a high degree of confidence” that the president is “not shedding infectious virus,” NBC said.

The network did not explicitly say that Mr. Trump had received a negative result from the P.C.R. test.

Mr. Trump and his aides have not shared extensive details about the president’s medical condition with the public, and over the past few days, NBC executives were no exception. Until late Tuesday, the network had been prepared to cancel the event if the president’s team did not present convincing evidence that Mr. Trump would not potentially infect those around him, one of the people said.

The town hall on Thursday will be held outdoors at the Pérez Art Museum in Miami, and audience members will be required to wear face masks, the network said. Ms. Guthrie and Mr. Trump will be seated at least 12 feet apart.

NBC officials began discussing the possibility of a town hall with the Trump campaign last week, after Mr. Trump pulled out of the second planned presidential debate. The network made clear at the start that it needed outside proof of the president’s medical condition.

NBC officials did not say exactly what testing

CRSwNP Highlights From the AAO-HNSF 2020 Virtual Meeting

The annual American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNSF) 2020 Meeting was held virtually this year and also included abstracts from the American Rhinologic Society Annual Meeting.

Stella Lee, MD, chief of the Division of Sino-Nasal Disorder and Allergy at the University of Pittsburgh Medical Center, reviews important studies and data presented at the meeting that could have important implications for patient care.

Dr Lee highlights developments in the use of protein biomarkers to help determine potential efficacy of systemic steroid therapy in postsurgical patients with CRSwNP. The study could aid in the prevention of overtreatment in certain patients.

Biologic therapies approved for use in asthma management continue to show efficacy in patients with CRSwNP. The results of the SYNAPSE study of mepolizumab, an anti-IL-5 biologic therapy, showed clear clinical benefit in patients with CRSwNP. The multi-institutional, phase 3 study met primary endpoints and showed that mepolizumab reduced the need for systemic corticosteroid therapy and sinus surgery.

Dr Lee also highlights data from the LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52 phase 3 studies on dupilumab, which indicated efficacy irrespective of the number of prior sinonasal surgeries. Dupilumab also consistently reduced rescue treatment with systemic corticosteroids vs placebo and was well tolerated.

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Genprex to Present at the Alliance for Regenerative Medicine’s Virtual Cell and Gene Meeting on the Mesa

Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that it will be presenting at the Alliance for Regenerative Medicine’s (ARM) virtual Cell and Gene Meeting on the Mesa, taking place October 12-16, 2020. Michael Redman, Executive Vice President and Chief Operating Officer of Genprex, will lead the company’s presentation.

The 2020 Cell and Gene Meeting on the Mesa will be delivered in a virtual format over the course of five days where attendees will be able to watch company presentations on-demand, in addition to two live-streaming panels each day. The Cell and Gene Meeting on the Mesa is the sector’s foremost annual conference, bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies.

For more information on the conference, or to register, please visit https://www.meetingonthemesa.com.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute

Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting

Optometry and ophthalmology doctors to present latest analyses and updates from studies of its MAP therapeutics for mydriasis, pediatric myopia and presbyopia

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that Drs. Siddarth Rathi and April Jasper will present the latest analyses and updates from the company’s clinical studies at the American Academy of Optometry Academy 2020 At Home Con.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201005005232/en/

On Wednesday, October 7, April Jasper, OD, medical monitor for the company’s CHAPERONE study and member of the Eyenovia Scientific Advisory Board, will provide pre-recorded updates on the CHAPERONE (evaluation of low-dose atropine for the reduction of pediatric myopia progression) and the VISION (evaluation of low-dose pilocarpine for improvement in near vision) clinical trials. Dr. Jasper will also provide an update on the company’s upcoming Mydcombi (low-dose tropicamide and phenylephrine fixed combination for pupil dilation) NDA filing with the U.S. Food and Drug Administration (FDA).

On Thursday, October 8 at 6 p.m. EDT, Siddarth Rathi, MD, of The Eye Institute of West Florida and medical monitor for the MIST 1 and MIST 2 studies, will present additional analyses of data from the MIST 1 and MIST 2 studies of Eyenovia’s proprietary first-in-class fixed combination microdose formulation of phenylephrine and tropicamide for mydriasis (pupil dilation). Clinical results will cover Pupil Dilation Speed with MAP™ Fixed Combination (FC) Tropicamide 1% Phenylephrine 2.5% (TR-PH)-Ophthalmic Solution.

About Eyenovia

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, please visit www.eyenovia.com.

About MicroPine for Progressive Myopia

MicroPine (atropine ophthalmic solution) is being evaluated in the CHAPERONE Phase 3 clinical study for reduction in pediatric myopia progression. Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, myopic maculopathy, retinal detachment, posterior subcapsular cataract, glaucoma and visual impairment. MicroPine has been developed for comfort, hygiene and ease-of-use in children. Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).

Feasibility Dose-finding Atropine Studies: ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials)

About MicroLine for Presbyopia

MicroLine (pilocarpine ophthalmic solution) is a pharmacologic treatment for presbyopia which will be evaluated in the VISION 1 and VISION 2 Phase 3 clinical studies. Presbyopia is the non-preventable, age-related hardening of the natural lens, which causes a gradual loss of the eye’s ability to accommodate or focus on nearby