Topical MEK inhibitor NFX-179 Shows Promise in Shrinking Cutaneous Neurofibromas in NF1 Patients

NEW YORK (PRWEB)
January 10, 2023

The Children’s Tumor Foundation (CTF) entered a new phase in its strategic NF research model by announcing a significant impact investment in a Phase 2b clinical trial at NFlection Therapeutics, a biotechnology company focused on the discovery and development of effective, targeted therapies for rare disorders. The trial involves NFX-179, a topical (on the skin) treatment which has successfully passed a Phase 1/2a (safety and first signs of efficacy) trial. The current Phase 2b study will more rigorously test the drug’s safety and effectiveness.

The NFX-179 treatment is for cutaneous neurofibromas (cNF), which are tumors that grow in the skin or right underneath the skin, and result in severe, disfiguring bumps on the skin. The vast majority of NF1 patients have cNF that are responsible for significant negative effects on the quality of life, including pain, itching, and emotional / appearance concerns as a result of bullying or discrimination.

NFX-179 is a topical, metabolically labile, MEK inhibitor, which is the same mechanism used in the drug Koselugo (selumetinib), which has previously received FDA and EMA approval for inoperable plexiform neurofibromas. Koselugo is an oral drug that has systemic impact on the body. CTF was an early-stage funder of both animal and in-human studies that led to the discovery that MEK has the potential to shrink tumors.

This new use of MEK as a ‘soft’ topical inhibitor designed specifically for cutaneous neurofibromas is to impact locally while minimizing side effects. There is a high unmet need for this treatment. CTF is making a landmark impact investment in these next phase topical studies to help accelerate the development of this promising treatment, which should it prove successful, means more quickly delivering important life-changing treatments to patients.

CTF’s investment strategy in NF drug development is a diversified portfolio approach to tackling all forms of NF, from early-stage investments in young investigators to established academic initiatives in the Discovery Fund, to large-scale, open data collaboratives such as Synodos. CTF has operated as a strategic partner to all stakeholders who can help bring effective treatments to the patients. This first-in-its-history impact investment further establishes CTF as a co-investor with pharma/biotech in innovative NF research, expanding opportunities to increase the NF drug development pipeline.

“We’re thrilled to be working with NFlection on this incredible opportunity to bring life-changing treatments to NF patients,” said Annette Bakker, President of the Children’s Tumor Foundation. “CTF is mainly known as a seed funder, willing to take risk, and willing to put a lot of sweat equity to advance the science and the treatments. With our recent investments in science and pharma, we are sending a clear message that if we want to accelerate treatments, NF deserves serious funding. With the tremendous support of the CTF Board of Directors and the CTF Business Advisory Council, we are ready to demonstrate ‘skin-in-the-game’. This will hopefully increase confidence for others to invest in NF. NF research provides good return, both as a research investment for pharma and biotech, and most importantly, the ultimate return of better lives for the millions affected who are waiting for our help.”

“We’re thankful to the Children’s Tumor Foundation for this investment in our work,” said William Hodder, CEO of NFlection Therapeutics. “We believe – with good reason, based on our previous results – that this treatment has the potential to help so many. We’re also grateful for the connectivity CTF brings with this partnership to NF patients, clinics, and experts. It is known from other disease foundations that investments from medical research foundations like CTF may convince other investors that supporting NFlection is the right path forward.”

NF is a group of genetic disorders known as neurofibromatosis or schwannomatosis. It affects 1 in 3,000 births of all populations (about 2.5 million worldwide), and can cause deafness, blindness, bone abnormalities, disabling pain, learning disabilities, and cancer.

Over the past decade, CTF has worked to grow the NF field, which in addition to expanding partnerships with academic researchers, public/government researchers and funders, now has a growing number of pharma/biotech companies in the space. In addition to NFlection, they include Alexion/AstraZeneca, Takeda, SpringWorks, Novartis, Vivace, Pfizer, Healx, and NF2 Therapeutics, just to name a few.

Gabriel Groisman, Chairman of CTF’s Board of Directors said: “The evolution of NF research has come so far in recent years, thanks in large part to the herculean efforts of the Children’s Tumor Foundation. With this investment, we are taking the first step in our new approach to ending NF. The Foundation’s Board of Directors and the Business Advisory Council have made the bold decision that it’s time to start directly investing in select impact opportunities in the private sector that have the potential of bringing relief to NF patients as quickly as possible. Pharma and biotech can now look to CTF as a true partner, not just for knowledge and access to stakeholders, but also as a strategic investor. We at CTF are all in to find treatments and ultimately a cure for NF.”

Thanks to the generous connections of CTF Business Advisory Council (BAC) member Trinna Cuellar, as well as the BAC’s chairmen Alex Zisson and Randall Stanicky, CTF is very grateful for the pro bono legal advice from Wilson Sonsini Goodrich & Rosati on this impact investment.

To learn more about NF and CTF, please visit ctf.org.

To learn about partnership and investment opportunities with CTF, please contact info@ctf.org.

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Schaus Dental Studio in Golden Valley, MN

“BioRejuvenation dentistry is one of the most cutting-edge and promising approaches to restoring mouths to a healthy state. It is based on years of biological research, which shows that rehabilitating a patient’s mouth to an optimal position has lasting oral and overall health benefits.”

GOLDEN VALLEY, Minn. (PRWEB)
January 10, 2023

Dr. Paul Schaus, the founder of Schaus Dental Studio, serving Hennepin County has launched a new website (https://www.schausdentalstudio.com), which highlights the practice’s specialty in BioRejuvenation services, and digital dentistry technologies. A former naval dentist, Dr. Schaus’ concierge practice in the suburbs of Minneapolis is at the forefront of emerging dental technologies, leveraging both the power of the human body and the power of technology to provide a premium patient experience.

Harnessing the body’s natural ability to heal and restore itself to optimal health lies at the root of BioRejuvenation dentistry. Dr. Schaus specializes in this proactive, yet conservative treatment which restores teeth to their original, youthful shape, all the while optimizing the function of the mouth.

“BioRejuvenation dentistry is one of the most cutting-edge and promising approaches to restoring mouths to a healthy state. It is based on years of biological research, which shows that rehabilitating a patient’s mouth to an optimal position has lasting oral and overall health benefits,” Dr. Schaus said.

Using minimally invasive methods to restore the natural biology of each person’s dental system, the goal of BioRejuvenation dentistry is to achieve a proper balance between the upper and lower teeth. Once this balance is achieved the need for costly restorations in the future is mitigated. Treatments involved in BioRejuvenation of the mouth and teeth may include treatment for TMJ disorders, bite alignment, and the restoration of individual teeth.

Ultimately, this rehabilitation results in relief from pain, improved dental function, and an aesthetically improved smile, all the while setting the stage for excellent oral health in the future. “We promote BioRejuvenation because it allows our patients to break cycles of lifelong dental disease,” he explained.

BioRejuvenation is supported and complemented by Digital Dentistry, which Schaus Dental Studio also embraces. “Advances in technology offer greater accuracy and precision for screening, diagnosis, implant surgeries and restorative techniques. They also offer a more comfortable, expedited experience for patients,” Dr. Schaus said. Digital technologies used at Schaus Dental Studio include digital x-rays, intra-oral cameras, 3D digital scanning replacing impressions and computer-assisted design (CAD) of restorations and appliances.

In addition, digital screens are located in each practice area, which Dr. Schaus uses to educate patients about various problems, and what they can expect from various procedures. Wi-Fi is also available in the office, and patients can request appointments online by visiting the practice’s new website.

At Schaus Dental Studio, Dr. Schaus and his team provide preventative screenings and cleanings, and dental restorations including dental implants, crowns, and bridges. He also provides cosmetic treatments including teeth whitening, porcelain veneers, and dental implants.

For more information visit https://www.schausdentalstudio.com or call 763-525-0306. Schaus Dental Studio is located at 7575 Golden Valley Road Suite 240, Golden Valley, MN 55427.

About Paul V. Schaus DDS

Dr. Paul V. Schaus graduated from the University of Minnesota School of Dentistry. He then entered the United States Navy Dental Corps, serving service members aboard the aircraft carrier USS Theodore Roosevelt. His service included a deployment to the Middle East. Before opening Schaus Dental Studio in Golden Valley, Dr. Schaus had a private dental practice in Oak Grove, MN.

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Laurent Clerc National Deaf Education Center

WASHINGTON (PRWEB)
January 10, 2023

The Laurent Clerc National Deaf Education Center (Clerc Center) at Gallaudet University announced this week the public launch of the Clerc Center Online Community, a unique online resource center advancing the education of deaf children and young adults.

The Clerc Center Online Community, now open to the public, is a direct extension of the Clerc Center, a federally-funded national deaf education center, and supports its mission to ensure that the diverse population of deaf and hard of hearing students from birth through age 21 in the nation are educated and empowered to maximize their full potential as productive and contributing members of society.

The Online Community is designed to serve multiple audiences including parents and families with deaf and hard of hearing children, early childhood interventionists and development specialists, educational professionals, and healthcare providers. Its goal is to serve as a supportive community and the leading centralized hub where families and deaf education professionals can network with one another and secure expert resources and informed choices for their ongoing work with deaf children.

The Online Community includes resources to go; online training and learning; networking with others; live events; and ongoing support. Among the many resources visitors can find at the Online Community are several learning modules, including Advocacy for Your Child; Fifteen Principles for Reading to Deaf Children; Multilingual Families and Homes; and K-12 ASL Content Standards.

Since its founding in 1969, the Clerc Center (formerly Gallaudet University’s Pre-College National Mission Programs) with its two model and demonstration schools, the Kendall Demonstration Elementary School (KDES) and the Model Secondary School for the Deaf (MSSD), has served as a leading institution in best practices for the advancement of deaf education in pre-college settings.

“We are very pleased to officially launch the Clerc Center Online Community to the public,” said Marianne Belsky, the Chief Academic Officer of the Clerc Center. “The Online Community meets a longstanding need for a centrally accessible site where families and professionals alike can go to take advantage of the Clerc Center’s deep portfolio of resources and expertise in deaf education. They will also find resources from partnering organizations that the Clerc Center works with to encourage growth and advancement of excellence in deaf education.”

Nicole Sutliffe, the Chief Administrative Officer of the Clerc Center, added, “We know that still today many parents, families, and educators are wanting and looking for guidance on how to support their ability to provide the very best in deaf education for their students and children. We are very excited that starting today, we now have the perfect home to deliver this to our allies throughout the U.S. and beyond.”

About the Clerc Center

The Laurent Clerc National Deaf Education Center (Clerc Center) at Gallaudet University is a federally funded center with exemplary elementary and secondary education programs for deaf and hard of hearing students and is tasked with developing and disseminating innovative curricula, instructional techniques, and products nationwide while providing information, training, and technical assistance for parents and professionals to meet the needs of deaf and hard of hearing students from birth to age 21. More information about the Clerc Center can be found at http://clerccenter.gallaudet.edu/

Media Contacts:

Tyrone Giordano, Director of Communications, Clerc Center

tyrone.giordano@gallaudet.edu / 202-572-9213

Robert B. Weinstock, Senior Public Relations Manager, Gallaudet University

robert.weinstock@gallaudet.edu / 202-250-2411

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“I am grateful for the support of our US Senators from Maryland for these innovative research centers. Building on Hood’s academic strengths in these areas, the new facilities will enable students and faculty to address local and global challenges.” said Hood President Andrea E. Chapdelaine, Ph.D.

FREDERICK, Md. (PRWEB)
January 10, 2023

Hood College will receive $1 million from congressionally directed spending via the Fiscal Year 2023 Omnibus Appropriations Bill, secured by U.S. Senators Ben Cardin and Chris Van Hollen (D-Md.), to fund two new centers: the Marlene Grossnickle Young ’76, H’14, P’09 and Michael S. Young, P’09 Data Driven Frederick Center (DDF) and the Biomedical Research and Training Center.

Funding for these projects comes from congressionally directed spending requested by Senators Cardin and Van Hollen and enacted as part of the fiscal year 2023 omnibus government funding bill.

Previously called earmarks, congressionally directed spending has returned for a second year after a ten-year hiatus, allowing members of Congress to present important projects in their state or district for consideration by the Appropriations Committee. Cardin and Van Hollen presented these projects to the Appropriations Committee as investments designed to benefit the State of Maryland and the Frederick community.

Together, Senators Cardin and Van Hollen secured $36.5 million in congressionally directed spending for education and workforce development projects throughout the state of Maryland in the FY23 omnibus. This funding further advances Hood College’s Forging the Future campaign, which has raised nearly $64.7 million toward its $65 million goal.

“On behalf of the Hood and Frederick community, I am grateful for the support of our U.S. Senators from Maryland for these innovative research centers. Building on Hood’s historic and growing academic strengths in these areas, the new facilities will enable our students and faculty to help address both local and global challenges in partnership with Frederick biomedical research and manufacturing industries, government, businesses and nonprofits,” said Hood College President Andrea E. Chapdelaine, Ph.D. “Undergraduate and graduate students, as well as our partners’ employees, will acquire cutting-edge, high-demand skills that will address regional workforce needs, further strengthening the scope and quality of Hood’s educational offerings.”

“Investing in STEM education is key to equipping Marylanders with the tools they need to tackle 21st-century challenges and compete for 21st-century jobs. The direct federal funding we delivered for Hood College will address both sides of that equation by enhancing research efforts and training students to succeed in industries of the future. With these funds, Hood College will help unlock more opportunity for students in our state,” said Senator Van Hollen.

“I’m proud to support these two federal investments that bolster Hood College’s ability to serve two identified needs for the Frederick community in supporting nonprofit organizations and the biomedical workforce,” said Senator Cardin. “This funding will help to establish these distinct centers that will have the dual benefit of training Hood College students with the skills necessary for the region’s in-demand professions while providing a benefit to local community organizations.”

For more information on Data Driven Frederick and the Biomedical Research and Training Center, click here to view the full release on Hood’s website.

About Hood College

Hood College is an independent, liberal arts college, offering more than 30 bachelor’s degrees, four pre-professional programs, 19 master’s degree programs, two doctorates and 10 post-baccalaureate certificates. Located in historic Frederick, near Washington, D.C., Baltimore and the I-270 technology corridor, Hood gives students access to countless internships and research opportunities.

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With the addition of Jubilant’s Norcross Radiopharmacy to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain.

BOSTON (PRWEB)
January 10, 2023

Life Molecular Imaging (LMI) and Jubilant Radiopharma announce today that both companies have entered into a strategic partnership and licensing agreement providing Jubilant Radiopharma with rights to manufacture and distribute Neuraceq® in the Southeast Region of United States.

Jubilant Radiopharma will manufacture Neuraceq® at their PET cyclotron facility which has an adjoining SPECT radiopharmacy in Norcross, GA. The first doses will be available from January 18th, 2023.

Neuraceq® is an approved imaging agent for the detection of beta-amyloid plaques in the brain of adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline. It is used in clinical routine and is also a powerful imaging biomarker for the appropriate characterisation of subjects enrolled in clinical trials to support drug development in neurodegenerative diseases.

“With the addition of Jubilant’s Norcross Radiopharmacy to our distribution network, Life Molecular Imaging continues to expand the availability of Neuraceq®, an important diagnostic imaging tool for the detection of beta-amyloid plaques in the brain. We are truly excited about this collaboration with Jubilant Radiopharma to make our approved beta-amyloid tracer Neuraceq® even more available to physicians and their patients and to our pharma partners for routine clinical and research use”, said Ludger Dinkelborg, Ph.D., Managing Director at LMI.

“It is a great pleasure to have signed this important manufacturing and distribution agreement with Life Molecular Imaging” – declares Renato Leite, President at Jubilant Radiopharmacies. “Our strategic partnership with LMI will expand the availability of the innovative molecular imaging agent Neuraceq®, to patients in the Southeast contributing to the fight against Alzheimer’s disease and other causes of cognitive decline”.

About Neuraceq® (florbetaben 18F)

Indication

Neuraceq® is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.

A negative Neuraceq® scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq® scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq® is an adjunct to other diagnostic evaluations.

Limitations of Use

· A positive Neuraceq® scan does not establish the diagnosis of AD or any other cognitive disorder.

· Safety and effectiveness of Neuraceq® have not been established for (i) predicting development of dementia or other neurologic conditions and (ii) monitoring responses to therapies.

Important Safety Information

Risk for Image Interpretation and Other Errors

Neuraceq® images should be interpreted independent of a patient’s clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positives) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.

Radiation Risk

Administration of Neuraceq®, like other radiopharmaceuticals, contributes to a patient´s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions

In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection site reactions, consisting of erythema (1.7%), injection site irritation (1.1%), and pain (3.4%).

About Life Molecular Imaging (LMI)

Life Molecular Imaging (LMI, formerly Piramal Imaging) was formed in 2012 with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG. It is now part of the Alliance Medical Group (a member of the Life Healthcare Group) offering an integrated business including research and development laboratories, a network of cyclotrons, radiopharmacies and imaging facilities. By developing novel PET tracers for molecular imaging, LMI is focusing on a key field of modern medicine. The organization strives to be a leader in the Molecular Imaging field by developing innovative products that improve early detection and characterization of chronic and life-threatening diseases, leading to better therapeutic outcomes and improved quality of life. Please visit https://life-mi.com.

About Life Healthcare Group

Life Healthcare is a global people-centered, diversified healthcare organization listed on the Johannesburg Stock Exchange. Life Healthcare has over 38 years’ experience in the South African private healthcare sector, and currently operates 66 healthcare facilities in southern Africa. Services include acute hospital care, acute physical rehabilitation, acute mental healthcare, renal dialysis, and wellness, occupational health, primary health and emergency medical services. The Group owns Alliance Medical Group, the leading independent provider of medical imaging services (MRI, CT, and PET scans) within Europe, operating internationally across 10 countries. Life Molecular Imaging, a division of Alliance is an integrated pharmaceutical business that includes research and development laboratories, access to a network of cyclotrons and radio-pharmacies and imaging facilities, with Life Radiopharma being Alliance’s distributor of radiopharmaceuticals to diagnose many types of diseases. Visit https://www.lifehealthcare.co.za/

About Jubilant Radiopharma

Jubilant Radiopharma (Jubilant Draximage Inc.) is a subsidiary of Jubilant Pharma Limited. The Radiopharma business comprises development, manufacturing and commercializing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of Improving Lives Through Nuclear Medicine on a global scale through Radiopharmaceuticals business with cGMP complaint and ISO 13485 certified manufacturing facilities and distribution through the radiopharmacies business which is the second largest network in the US with 48 radiopharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals.

For media inquiries

Contact:

Nick Karabatsos, Chief Commercial Officer, Life Molecular Imaging: mailto:n.karabatsos@life-mi.com [n.karabatsos@life-mi.com __title__ null]

Jonathan Pharr, Director of Marketing, Jubilant Radiopharma: mailto:Jonathan.Pharr@jubl.com [Jonathan.Pharr@jubl.com __title__ null]

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STAMFORD, Conn. (PRWEB)
January 10, 2023

ReferWell, the digital health company focused on leveraging the “referable moment”SM to find and schedule patient care, today announced that it has closed its Series B funding round led by the healthcare private equity firm, Viewside Capital Partners.

Investors from Essen Ventures, the venture arm of Essen Health Care, a fully integrated healthcare delivery network in New York, joined existing investors Health Catalyst Capital and Connecticut Innovations in the funding round. Essen will deploy ReferWell across its entire organization encompassing more than 400 providers across nearly 50 locations.

Stephen Raggio, Co-Founder and Managing Partner of Viewside, stated “Referwell is on the leading edge of solving a persistent obstacle in a unique way – getting patients scheduled for the care they need with the right in-network provider. The payer, provider and hospital system markets are responding with aggressive uptake and we expect substantial continued growth in the future. Their organization has been built to scale, and the ReferWell team has deep experience and a proven track record. Viewside Capital is extremely excited to be a part of a solution that improves patient outcomes while also lowering the overall cost of care.”

ReferWell CEO Vytas Kisielius said the company will use the funds to continue to scale rapidly in a space historically limited by manual, time-intensive work. “ReferWell’s ability to tech-enable a complex task—navigating healthcare and scheduling appointments—is fundamental to every aspect of healthcare,” said Kisielius. “As a result, we’re adding many new payor and provider clients while our existing customers expand rapidly.”

ReferWell is gaining meaningful traction with Medicare and Medicaid health plans searching for efficient and effective member engagement strategies that help meet federal requirements. In targeted programs last year, ReferWell care navigators reached out to nearly 60,000 beneficiaries and recorded an impact rate up to ten-times higher than plan benchmarks.

ReferWell was founded in 2014 by a New York City-based cardiologist who wanted to make it easier for patients to receive follow-up care. While the company has entered additional markets and expanded the scope of its services, the original mission endures today: make it easy for patients to find and schedule appointments at the point-of-care (the original referable moment) and enable the sharing of patient clinical information between providers to enhance and simplify care coordination.

About ReferWell:

ReferWell is a digital health company focused on leveraging the referable momentSM — the point in time when a person is most ready to take action to improve their health – to improve access to care, increase health plans’ quality performance and reduce the total cost of care, all while improving members’ experience and outcomes. ReferWell’s intuitive technology platform and skilled service team helps health plans and providers manage value and help more people get on, and stay on, their healthcare journey. ReferWell, headquartered in Stamford, Connecticut, has grown to support plans responsible for more than 28 million covered lives across the U.S.

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