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Disproportionate Rise In Pancreatic Cancer Among Young Women Highlights High Unmet Need To Find Safe, Effective Treatments – Is Hope On The Horizon?

Benzinga

By Anthony Termini, Benzinga In 2023, television personality Maria Menounos acknowledged that she had been diagnosed with pancreatic cancer. Fortunately for Menounos, physicians detected the rare, less aggressive form of the disease when it was still in an early stage. Pancreatic cancer is one of the least survivable forms of the disease. According to the National Institutes of Health (NIH), pancreatic cancer is currently the third leading cause of cancer-related deaths in America. Furthermore, Menounos’s case is part of a disturbing trend. Incidents of pancreatic cancer are increasing, with the number of cases in women under the age of 55 rising at a disproportionate rate compared to men. Pancreatic Cancer Is Difficult To Find And Painful To Treat When it is in the early stages, pancreatic cancer usually offers no clearly-identifiable symptoms. The types of screens suggested for breast cancer or colon cancer don’t exist for pancreatic cancer, and there is no single diagnostic test to detect it. According to Johns Hopkins University, a clear diagnosis typically emerges only after an extensive series of imaging scans, blood tests and biopsies. Since these tests are generally conducted only after symptoms are felt, an initial diagnosis often reveals that the cancer is in an advanced stage that has spread to other organs. As a result, most patients tend to get a relatively aggressive form of chemotherapy. The combination of drugs used can often result in severe side effects. However, that may change as a result of work being conducted in current clinical trials. A Novel Approach To Treat Pancreatic Cancer Holds Promise Rockville, Maryland-based Theriva Biologics (AMEX: TOVX) is currently in a phase 2b trial with patients diagnosed with metastatic pancreatic ductal adenocarcinoma (PDAC). Theriva is a leader in the development of oncolytic virus therapies – treating cancer with viruses that target tumors. Theriva’s lead therapy candidate is VCN-01, a highly differentiated oncolytic adenovirus that replicates and destroys cancer tissue. The trial is studying the use of VCN-01 in combination with two forms of chemotherapy drugs. Oncolytic virus therapies target specific genes or proteins involved in the disease process to block or alter their activity and ultimately halt or reverse disease progression. The goal is to help patients live longer with less severe side effects. Theriva’s trial results so far appear promising. “We believe VCN-01’s differentiated mechanism of action has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the tumor matrix and increasing tumor access,” said Steven Shallcross, Theriva’s CEO. The company’s current clinical trial is studying a combination of VCN-01 with a drug that mimics some of the building blocks of RNA and DNA to disrupt a cancer cell’s ability to make proteins (Gemcitabine) and one that includes a human protein to stop cancer cells from dividing and multiplying (nab-Paclitaxel). The NIH notes that gemcitabine has been the standard first-line treatment for advanced pancreatic cancer for 15 years and is often used in combination with nab-paclitaxel as first-line treatment for pancreatic cancer. Theriva’s Shallcross noted that repeated systemic dosing of VCN-01 with this standard-of-care chemotherapy is feasible from a safety perspective. “We have shown that the combination has an acceptable safety profile, and can now focus on whether the repeated-dose VCN-01 regimen may lead to improved clinical outcomes for patients with PDAC and other solid cancers,” he said. Studying Pancreatic Cancer Offers Challenges, And The Need Is Large According to gastrointestinal oncologist Mridula Krishnan, MBBS, “Pancreatic cancer is not an easy cancer to study and, especially when it comes to gender-related studies, it’s very tough to find answers.” This is part of what makes Theriva’s work so important. The company believes that its oncolytic viruses are particularly well-positioned for use with other therapies to help pancreatic cancer patients achieve improved outcomes with fewer negative side effects. Mr. Shallcross noted that there is a “high unmet need” and that the company is continuing “to build a portfolio of potentially improved therapeutic combinations for PDAC patients.” According to DataBridge Market Research, that high unmet need is estimated to reach more than $6.2 billion by 2029. Theriva Biologics is also exploring the potential of VCN-01 as a possible candidate as part of other chemotherapy combinations to treat pediatric refractory retinoblastoma and adult ovarian cancer. Featured photo by PublicDomainPictures on Pixabay. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

July 09, 2024 08:45 AM Eastern Daylight Time

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This Biotech Just Cleared A Big FDA Hurdle In Its Quest To Improve ADHD Treatment

Benzinga

By Johnny Rice, Benzinga Dr. Ann Childress and Shane Schaffer, Chairman & CEO of Cingulate (NASDAQ: CING), were recently guests on Benzinga’s All Access. Cingulate is a biotechnology company developing drugs for a range of underserved conditions. The company has developed a proprietary technology called Precision Timed Release™ (PTR™). The technology allows a single pill to contain multiple doses of a drug, relieving the pill burden many people with chronic conditions suffer. Cingulate was just given clearance by the FDA to seek full approval for its lead candidate, CTx-1301. Watch the full interview here: Featured photo by Hal Gatewood on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

July 03, 2024 08:30 AM Eastern Daylight Time

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Vivos One Step Closer To Transforming Cancer Treatment With FDA Application To Start Human Trials For Pioneering Injectable Brachytherapy Device

Vivos Inc.

By Meg Flippin, Benzinga In what could prove to be a transformational development in cancer treatment, Vivos (OTCQB: RDGL), the maker of the Radiogel™ Precision Radionuclide Therapy, submitted an application to the U.S. Food and Drug Administration (FDA) to initiate human clinical trials. The Investigational Device Exemption (IDE) application is an amendment addressing the FDA’s comments about the company’s previous application. Once it's granted approval, Vivos can begin testing its therapy on humans to treat solid metastatic tumors, particularly in lymph nodes associated with papillary thyroid cancer. How RadioGel Works RadioGel, a pioneering Yttrium-90-based injectable brachytherapy device, represents what the company says is a groundbreaking approach to cancer treatment. It is designed for patients who are either not eligible for surgery or have chosen not to undergo the procedure, particularly those with non-radioiodine avid disease and limited burden regional nodal disease. The therapy involves directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor. This method allows for a more localized and potent radiation treatment compared to traditional external-beam radiation therapies. First Filing Since Breakthrough Device Designation The application marks Vivos’ first filing with the FDA since being granted FDA Breakthrough Device Designation for the Radiogel ™ Precision Radionuclide Therapy. The Breakthrough Devices Program by the FDA is designed to accelerate the development and review of innovative technologies that show potential for more effective treatment options. The program's support is instrumental in hastening patient access to promising medical advancements like RadioGel. The technology behind RadioGel allows for the safe delivery of higher doses necessary for treating non-resectable and radiation-resistant cancers. The product also boasts a short half-life, delivering over 90% of its therapeutic radiation within ten days. That will be welcome news to cancer sufferers, given other treatments can require up to six weeks for a full course of radiation therapy. Additionally, the outpatient nature of the RadioGel therapy means patients can return home without concerns about radiation exposure to family members. Vivos Is Ready Since receiving that status, Vivos said the communication with the FDA has improved further, which is important to ushering this treatment along. The IDE filing includes reports on two studies – RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. Vivos said the IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, the company repeated underlying testing to strengthen its answers with current data. “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly,” said Dr. Michael Korenko, President and CEO of Vivos. “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.” Vivos, in collaboration with the Mayo Clinic, is working hard to develop treatments to fight challenging cancer types, offering hope and potentially more effective treatment options to people around the globe. The IDE application puts it one step closer to realizing that dream. Featured photo by National Cancer Institute on Unsplash. Vivos Inc. has developed a Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat solid tumors in animals (IsoPet®) and humans (RadioGel™). Using the company's proprietary hydrogel technology, brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michael K. Korenko info@vivosinc.com Company Website http://www.vivosincusa.com

July 02, 2024 09:00 AM Eastern Daylight Time

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Shedding Light on Cystic Fibrosis

YourUpdateTV

Cystic fibrosis (CF) is a rare, progressive, and genetic disease that currently affects about 40,000 people in the United States. CF is the result of a defective gene, inherited from each parent, and the disease can impact people of all races and ethnicities. Recently, KC White, Board Chair of the Cystic Fibrosis Foundation, participated in a nationwide satellite media tour to discuss the disease, her personal journey, and how the Foundation is helping progress care and treatment options. A video accompanying this announcement is available at: https://youtu.be/8wj8u0JEqLU CF is a life-shortening disease that prevents our bodies from clearing mucus. This can lead to lung infections, poor nutrition, lung disease, and a host of unique challenges that can impact every aspect of a person’s life. When it was first discovered, it was considered a fatal pediatric disease. But due to transformative advancements in treatments and high-quality care, the life-expectancy for someone born with CF today is 56. While that number is climbing there is still a long way to go and unfortunately, not all people with CF equally benefit from this progress. KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood and is the first person with CF to serve as board chair. When she was diagnosed, she wasn’t expected to live past high school age, but her family refused to accept that fate, which prompted their dedication to the Foundation’s work. Because of recent treatments known as modulators, about 90% of the CF population (including KC) experienced an incredible transformation in their health. With this though, comes navigating unplanned challenges including careers, finances, family, and more. In addition to fueling the research, particularly in genetic therapies, that will lead to transformative treatments for the entire CF population, the CF Foundation works to support the CF community in all aspects of their lives through support programs and fostering connection opportunities. The CF Foundation is committed to finding a cure and providing all people with CF the opportunity to lead long, fulfilling lives. The Foundation is aggressively funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. For more information, visit CFF.ORG About KC White KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood, speaking at her first Foundation event when she was only 9 years old. She is the first person with CF to serve as board chair. White received her Master of Applied Positive Psychology from the University of Pennsylvania in 2022 and currently serves as an assistant instructor in the program. She is also the Head Varsity Women’s Lacrosse coach for the Chagrin Falls, Ohio, Tigers. She and her husband, Justin, have one son, Mac. About the Cystic Fibrosis Foundation The Cystic Fibrosis Foundation is a donor-supported nonprofit organization leading the relentless pursuit of a cure for cystic fibrosis. The Foundation is committed to providing all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. The Foundation funds more CF research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. The organization supports and accredits a national network of over 130 CF care centers recognized by the National Institutes of Health as a model of care for a chronic disease. Also, the Foundation manages support programs and fosters connection opportunities for the CF community. Based in Bethesda, Md., the Foundation’s impact is made possible by the work of nearly 70 local chapters across the country. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 28, 2024 12:45 PM Eastern Daylight Time

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Tiziana Life Sciences adds to treasury with $3.4 million in non-dilutive funding

Tiziana Life Sciences Ltd

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chairman and CEO Gabriele Cerrone joined Proactive's Stephen Gunnion with more details of the company's recent advancements and news. Tiziana Life Sciences is developing a fully human CD3 monoclonal antibody, delivered intranasally, specifically targeting neurodegenerative diseases such as multiple sclerosis (MS) and Alzheimer's disease. Cerrone discussed the company's progress in MS treatments, highlighting its expanded access trial at Harvard University's Brigham and Women's Hospital. Notably, 70% of patients in the trial showed improvement in fatigue scores, while 80% experienced reduced brain inflammation. The company is also preparing to dose the first Alzheimer's patients in a new trial approved by the FDA. Furthermore, Tiziana Life Sciences is exploring the combination of its drug with GLP-1 antagonists to target obesity-related diseases. Cerrone shared the exciting news of securing $3.4 million in non-dilutive funding, emphasising its commitment to protecting shareholder investments. "We have seen extraordinary improvements in patients, and we are thrilled about the potential impact of our treatments on neurodegenerative diseases," he remarked. Visit Proactive's YouTube channel for more videos, and don't forget to give the video a like, subscribe to the channel, and enable notifications for future content. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 28, 2024 07:53 AM Eastern Daylight Time

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News Release

NanoViricides Reports Promising Results for NV-387 in Influenza A H3N2 Mouse Model

Nanoviricides Inc

NanoViricides CEO Dr Anil Diwan joined Steve Darling from Proactive to share promising news about the company's ultra-broad-spectrum antiviral, NV-387. The antiviral was found to be effective in protecting lungs from damage in a lethally infected Influenza A H3N2 mouse model. Dr. Diwan explained that the lung protection provided by NV-387 is particularly important, as severe cases of respiratory viral infections, which often lead to hospitalization and fatalities, typically involve extensive lung damage. In the study, NV-387 oral treatment resulted in only about 31% lung infiltration by immune system cells, while NV-387 intravenous treatment showed an even lower infiltration rate of about 22%. In comparison, the lungs of infected untreated animals exhibited a high infiltration rate of 68%. These findings indicate that NV-387 significantly protects the lungs of Balb/c mice lethally infected with the Influenza A H3N2 virus. Moreover, NV-387 treatment resulted in a significantly greater survival improvement compared to three approved influenza drugs. This remarkable outcome highlights the potential of NV-387 as a powerful therapeutic option for treating severe influenza infections and possibly other respiratory viral infections. Further, in this study, NV-387 was also found to protect the lungs of the infected animals from viral damage as well as immune system damage, supporting a strong antiviral effect. These results have arrived just as the bird flu H5N1 threat potential has increased significantly due to its spread into several mammalian species. While dairy cattle have suffered relatively mild infections, some other mammals, particularly cats on farms, have died of brain infection with this virus. Only four human cases have occurred so far, with one person dying in Mexico, while the three other cases, all in the USA, have recovered. This highlights the urgency and potential impact of NV-387 in addressing not only current viral threats but also emerging ones, making it a critical development in the field of antiviral therapies. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

June 26, 2024 10:34 AM Eastern Daylight Time

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News Release

Promising Developments from OKYO Pharma on Dry Eye Disease and Neuropathic Pain Treatment

OKYO Pharma Ltd

OKYO Pharma Ltd CEO Gary Jacobs joined Steve Darling from Proactive to share additional key findings from the Phase 2 clinical trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). This trial involved 240 patients in a randomized, double-masked, placebo-controlled study. OK-101, developed using a membrane-anchored-peptide technology, is a novel long-acting drug candidate designed to treat dry eye disease. It has shown anti-inflammatory and pain-reducing efficacy in mouse models of dry eye disease and corneal neuropathic pain. Jacobs highlighted that the findings include a statistically significant and durable reduction in ocular pain and a statistically significant improvement in Tear Film Break-Up Time throughout the study, which is a clinically important endpoint. Additionally, multiple symptomatic improvements were observed through both data obtained from patient clinic visits and daily symptom diaries. Jacob explained that OK-101 targets a receptor called Chemerin 23, present on both immune and nerve cells, including those in the spinal cord and ocular nerves. Preclinical animal studies indicated that OK-101 could reduce neuropathic pain, which can be particularly severe and debilitating in affected patients. The company is preparing to launch a Phase II trial for OK-101 specifically targeting neuropathic corneal pain. This trial will be a placebo-controlled, randomized study involving 48 patients diagnosed with ocular nerve damage through confocal microscopy, with top-line data anticipated by mid-2025.The significance of this development is underscored by the lack of FDA-approved treatments for neuropathic corneal pain, a condition recognised by the National Organization of Rare Diseases. The upcoming trial aims to fill this therapeutic gap, potentially offering relief to patients suffering from this excruciating condition. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

June 26, 2024 10:29 AM Eastern Daylight Time

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BenevolentAI and AstraZeneca collaborate on new lupus target

BenevolentAI

BenevolentAI chief scientific officer Dr Anne Phelan speaks to Proactive's Stephen Gunnion about the addition of a novel systemic lupus erythematosus (SLE) target to AstraZeneca's discovery portfolio. Phelan discussed the collaboration between BenevolentAI and AstraZeneca, which began in 2019 focusing on idiopathic pulmonary fibrosis and chronic kidney disease and later expanded to include heart failure and lupus. She highlighted the benefits of this collaboration, stating, "We can really leverage the power of the interconnectivity of the data foundations to pull through potential target hypotheses irrespective of the disease." Phelan explained how BenevolentAI's data-driven approach, combined with AstraZeneca's disease expertise, facilitates the identification and validation of new therapeutic targets. She also provided insights into lupus, describing it as a debilitating autoimmune disease where the body's immune system attacks its own tissues, leading to chronic fatigue and damage to vital organs. The BenevolentAI platform's ability to handle complex data and generate explainable hypotheses is pivotal in identifying new therapeutic targets for such complex diseases. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 26, 2024 08:01 AM Eastern Daylight Time

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atai Life Sciences co-CEO says initial results from ELE-101 show promise in treating depression

atai Life Sciences

Atai Life Sciences co-founder and co-CEO Florian Brand discussed initial results from Beckley Psytech’s phase 1 trial of its patent-protected psilocin ELE-101 in patients with major depressive disorder. Brand explained that ELE-101 is an intravenous (IV) formulation of psilocin, the active metabolite of psilocybin, developed for depression treatment. The IV formulation aims to reduce treatment duration to two hours, compared to the longer sessions required by traditional psilocybin and LSD treatments. Phase one trials in healthy participants showed that ELE-101 was well tolerated with no serious safety concerns and had a predictable pharmacokinetic profile, supporting dose selection for phase two trials. Brand highlighted the commencement of phase 2 trials with the first patient already dosed. This study involves 6 to 12 patients, with data expected in the second half of this year. atai Life Sciences is optimistic about the shorter treatment duration, potentially making it more convenient for patients and less burdensome for the healthcare system. Additionally, Brand mentioned their involvement with Compass Pathways, which is developing psilocybin therapy, and noted the importance of the two-hour treatment paradigm established by the intranasal esketamine spray, Spravato. This paradigm could be leveraged for their other compounds, such as BPL-003 and DMT, also being developed for depression treatment. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 26, 2024 06:09 AM Eastern Daylight Time

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