Pneumonitis Prevention Protocol Using Pentoxifylline and Α-tocopherol in Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation (P4-PACIFIC)

Currently, the standard of care treatment for newly diagnosed, inoperable stage III non-small cell lung cancer is radiotherapy (RT) with concurrent chemotherapy, followed by immune checkpoint inhibitors (ICI). RT is a highly effect local treatment. However, high doses of radiation used in curative settings can cause adverse side effects. The most common RT side effect in lung cancer is Radiation Induced Lung Injury (RILI), which can manifest as pneumonitis and/or pulmonary fibrosis. Lung injury can negatively impact patients' well-being and quality of life, and may lead to increased mortality. Risk of lung injury is particularly increased when patients are treated with a combination of treatments (i.e., RT, chemotherapy, and ICI). The drug Pentoxifylline (in combination with α-Tocopherol (Vitamin E)) has been shown to prevent/alter the progression of lung injury and there is a growing body of evidence to support the safety and efficacy of phosphodiesterase inhibitors in cancer treatment. The proposed study aims to determine if the addition of Pentoxifylline, given in combination with α-Tocopherol (Vitamin E), to standard of care treatment will reduce side effects related to lung injury and improve quality of life in this study population.

Start Date30 Nov 2024

Sponsor / Collaborator

University Health Network

[+1]

IRCT20240316061302N1 / SuspendedPhase 2/3IIT

Investigation of vitamin C and vitamin E co-treatment in improvement of clinical and paraclinical findings of lung contusion patients

Start Date22 Oct 2024

Sponsor / Collaborator

Kerman Medical University

RBR-99h2qmf / Not yet recruitingNot ApplicableIIT

Vitamin E Supplementation in pregnant women with Severe Preeclampsia

Start Date01 Oct 2024

Sponsor / Collaborator

Universidade Federal do Rio Grande do Norte

100 Clinical Results associated with Vitamin E

100 Translational Medicine associated with Vitamin E

100 Patents (Medical) associated with Vitamin E

46,186

Literatures (Medical) associated with Vitamin E

01 Feb 2025·Current Drug Delivery

From Vision Correction to Drug Delivery: Unraveling the Potential of Therapeutic Contact Lens

Article

Author: Sharma, Mohit ; Swami, Rajan ; Singh, Indu ; Saini, Ankush

Contact lenses (CLs) have become an essential tool in ocular drug delivery, providing effective treatment options for specific eye conditions. In recent advancements, Therapeutic CLs (TCLs) have emerged as a promising approach for maintaining therapeutic drug concentrations on the eye surface. TCLs offer unique attributes, including prolonged wear and a remarkable ability to enhance the bioavailability of loaded medications by more than 50%, thus gaining widespread usage. They have proven beneficial in pain management, medication administration, corneal healing, and protection. To achieve sustained drug delivery from TCLs, researchers are exploring diverse systems, such as polymeric nanoparticulate systems, lipidic systems, and the incorporation of agents like vitamin E or rate-limiting polymers. However, despite breakthrough successes, certain challenges persist, including ensuring drug stability during processing and manufacturing, controlling release kinetics, and biomaterial interaction, reducing protein adhesion, and addressing drug release during packaging and storage etc. While TCLs have shown overall success in treating corneal and ocular surface disorders, careful consideration of potential issues and contraindications is vital. This review offers an insightful perspective on the critical aspects that need to be addressed regarding TCLs, with a specific emphasis on their advantages and limitations.

01 Feb 2025·Colloids and Surfaces B: Biointerfaces

Development and characterization of PVA-zein/α-tocopherol nonwoven mats for functional wound dressing applications

Article

Author: Tadele, Debela T. ; David, Dency ; Yim, Evelyn ; Mekonnen, Tizazu H ; Tadele, Debela T ; Mekonnen, Tizazu H.

Wound healing poses significant clinical challenges due to issues like bacterial infections, oxidative stress, and the need for sustained therapeutic delivery. This study aimed to develop and characterize biocompatible nonwoven fibrous mats composed of poly(vinyl alcohol) (PVA) and zein encapsulating α-tocopherol for wound dressing applications. α-Tocopherol was nano-encapsulated in zein proteins using an antisolvent co-precipitation method, followed by its dispersion in PVA solutions. The resulting composition was then processed using a novel, scalable, and inexpensive solution blow spinning (SBS) process that offers higher throughputs to generate non-woven mats. The resulting fibers in the non-woven mats, ranging in diameter from 350 nm to 796 nm, demonstrate uniform morphology, as confirmed by scanning electron microscopy. Fourier transform infrared (FTIR) spectroscopy validated the successful incorporation of α-tocopherol without altering the chemical structure of the PVA-zein matrix. Rheological assessments revealed Newtonian behavior and a decrease in viscosity with higher tocopherol content, enhancing the processability of the mats. Mechanical testing showed that increasing tocopherol content improved tensile strength, elongation, and Young's modulus. The mats exhibited a biphasic release profile with an initial burst and sustained α-tocopherol release over 24 h, fitting the Korsmeyer-Peppas model and hence indicating a diffusion-controlled mechanism. Cytotoxicity assays confirmed high cell viability (>90 %) and enhanced cell spreading, underscoring their biocompatibility. These findings suggest that PVA-zein/tocopherol fiber mats are promising candidates for functional wound dressing materials, offering sustained antioxidant activity and a favorable wound healing environment. Future work will focus on optimizing fiber composition for antimicrobial properties and conducting in vivo studies to validate their clinical efficacy.

01 Jan 2025·Behavioural Brain Research

Coenzyme Q10 and vitamin E alleviate heat stress-induced mood disturbances in male mice: Modulation of inflammatory pathways and the HPA axis

Article

Author: Kazmi, Sareh ; Athari, Seyed Zanyar ; Mahmoudi, Javad ; Hosseini, Leila ; Sadigh-Eteghad, Saeed ; Morsali, Soroush ; Bahari, Leila ; Ahmadi, Mahdi ; Vatandoust, Seyedmahdi ; Farajdokht, Fereshteh

Heat stress, as an environmental stressor, can lead to temperature dysregulation and neuroinflammation, causing depression and anxiety by disrupting brain physiology and functional connectivity. This study looked at how co-enzyme Q10 (Q10) and vitamin E (Vit E), alone and together, affected heat stress-caused anxiety and depression symptoms and inflammation in male mice. Five groups were utilized in the study: control, heat stress (NS), Q10, Vit E, and the combination group (Q10+Vit E). The mice were subjected for 15 min/day to a temperature of 43°C for 14 consecutive days, followed by daily treatments for two weeks with either normal saline, Q10 (500 mg/kg), Vit E (250 mg/kg), or their combination. The forced swimming test (FST) and tail suspension test (TST) were employed to evaluate despair behavior, whereas the elevated plus maze (EPM) and open field test (OFT) were used to assess anxious behaviors. Subsequently, the animals were sacrificed, and serum corticosterone levels, protein expression of inflammasome-related proteins, and hsp70 gene expression were evaluated in the prefrontal cortex (PFC). The study revealed that treatment with Vit E and Q10, alone or together, provided anxiolytic and antidepressant effects in the heat-stress-subjected animals. Also, giving Vit E and Q10 alone or together greatly lowered serum corticosterone levels. In the PFC, they also lowered the levels of hsp70 mRNA and NF-κB, caspase 1, NLRP3, and IL-1β proteins. It is speculated that treatment with Q10 and Vit E can attenuate heat stress-associated anxious and depressive responses by inhibiting the inflammatory pathways and modulating the hypothalamus-pituitary-adrenal axis.

News (Medical) associated with Vitamin E

12 Nov 2024

·www.businesswire.com

KOSELUGO® (selumetinib) Showed Significant and Clinically Meaningful Improvement in Objective Response Rate Versus Placebo in Adults With Neurofibromatosis Type 1 who Have Symptomatic, Inoperable Plexiform Neurofibromas in Global Phase 3 KOMET Trial

RAHWAY, N.J.--( BUSINESS WIRE )--Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KOMET trial, which is the largest, global randomized double-blind placebo-controlled multicenter Phase 3 trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Topline results showed that KOSELUGO, an oral, selective MEK inhibitor, demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the study’s primary endpoint, versus placebo, in these adult patients. Neurofibromatosis type 1 is a rare, progressive genetic condition affecting an estimated 1.7 million people worldwide, approximately 70% of whom are adults. In 30-50% of patients, tumors develop on the nerve sheaths and may cause debilitating symptoms. Neurofibromatosis type 1 is usually diagnosed in early childhood; however, NF1 often progresses into adulthood. There are no approved treatments for adults, leaving many to experience disfigurement, dysfunction, persistent pain or endure multiple surgeries. Professor Ignacio Blanco Guillermo, M.D., Ph.D., chairman, genetic counseling and clinical genetics program at the Germans Trias i Pujol University Hospital, chairman, Spanish National Reference Center for Adult Patients with Neurofibromatosis and principal investigator of the KOMET trial, said, “ With limited options to manage NF1 plexiform neurofibromas in adults, many patients experience functional impairment and symptoms, which can substantially impact their lives. These clinically meaningful data show KOSELUGO has the potential to make a positive impact in patient care by reducing the size of plexiform neurofibromas.” Marc Dunoyer, chief executive officer, Alexion, said, “ These promising results demonstrate that KOSELUGO, the first and only approved targeted therapy for certain children with NF1 plexiform neurofibromas, now has the potential to benefit adult patients for whom there are no approved targeted therapies. As the largest and only global placebo-controlled Phase 3 trial in adults with NF1 plexiform neurofibromas, KOMET reinforces our leadership in advancing potential treatment options for people living with this debilitating disease. We look forward to sharing these findings with regulatory authorities.” Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories, said, “ Adults with NF1 are in critical need of treatment options to help manage symptomatic, inoperable plexiform neurofibromas. These positive results from the Phase 3 KOMET trial demonstrate the potential to expand the use of KOSELUGO beyond pediatric patients to also treat adult patients living with this rare and challenging genetic condition.” In the trial, ORR was defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumor volume) by cycle 16 (28 days per cycle) as determined by independent central review (ICR) per response evaluation in neurofibromatosis and schwannomatosis (REiNS) criteria. The safety profile of KOSELUGO in this study was consistent with that observed in clinical trials among children and adolescents. No new safety signals were identified. Alexion, AstraZeneca Rare Disease will share these data with regulatory authorities and present these data at a forthcoming medical meeting. AstraZeneca and Merck are jointly developing and commercializing KOSELUGO globally. About KOMET KOMET is a global randomized, double-blind, placebo-controlled, multi-center Phase 3 trial (ClinicalTrials.gov, NCT04924608 ) designed to evaluate the efficacy and safety of KOSELUGO in adults with NF1 who have symptomatic, inoperable PNs. The trial enrolled 145 adults from 13 countries across the U.S., Asia, Australia, South America and Europe, with participants’ baseline characteristics, including gender and distribution of PNs, reflective of the global adult NF1 patient population. Patients were enrolled and randomized 1:1 to receive KOSELUGO or placebo for twelve 28-day cycles. Participants were required to have diagnosis of NF1 at least one, symptomatic, inoperable target PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrollment. The primary endpoint is confirmed ORR by cycle 16 as assessed by ICR. Objective response rate is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumor volume). After 12 cycles, patients on placebo were switched to KOSELUGO and patients on KOSELUGO remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete both treatment periods 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive KOSELUGO. About NF1 Neurofibromatosis type 1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene. Neurofibromatosis type 1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in 30-50% of patients, tumors develop on the nerve sheaths (PNs). These PNs can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction. Plexiform neurofibromas begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years. About KOSELUGO ® (selumetinib) KOSELUGO is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumor cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, KOSELUGO slows down the growth of tumor cells, and, therefore, the PN growth. KOSELUGO is approved in the U.S., European Union (EU), Japan, China and has been granted Orphan Drug Designation in the U.S., EU, Japan and other countries for the treatment of pediatric patients with NF1 PN who have symptomatic, inoperable PN. KOSELUGO (selumetinib) Indication in the U.S. KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Cardiomyopathy. A decrease in left ventricular ejection fraction (LVEF) ≥10% below baseline occurred in pediatric patients who received KOSELUGO in SPRINT with some experiencing decreased LVEF below the institutional lower limit of normal (LLN), including one patient with Grade 3. All patients with decreased LVEF were asymptomatic and identified during routine echocardiography. The safety of KOSELUGO has not been established in patients with a history of impaired LVEF or a baseline ejection fraction that is below the institutional LLN. Assess ejection fraction by echocardiogram prior to initiating treatment, every 3 months during the first year of treatment, every 6 months thereafter, and as clinically indicated. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. In patients who interrupt KOSELUGO for decreased LVEF, obtain an echocardiogram or a cardiac MRI every 3 to 6 weeks. Upon resolution of decreased LVEF, obtain an echocardiogram or a cardiac MRI every 2 to 3 months. Ocular Toxicity. Blurred vision, photophobia, cataracts, and ocular hypertension occurred. Retinal pigment epithelial detachment (RPED) occurred in the pediatric population during treatment with single agent KOSELUGO and resulted in permanent discontinuation. Conduct ophthalmic assessments prior to initiating KOSELUGO, at regular intervals during treatment, and for new or worsening visual changes. Permanently discontinue KOSELUGO in patients with retinal vein occlusion (RVO). Withhold KOSELUGO in patients with RPED, conduct ophthalmic assessments every 3 weeks until resolution, and resume KOSELUGO at a reduced dose. Gastrointestinal Toxicity. Diarrhea occurred, including Grade 3. Diarrhea resulting in permanent discontinuation, dose interruption or dose reduction occurred. Advise patients to start an anti-diarrheal agent (eg, loperamide) and to increase fluid intake immediately after the first episode of diarrhea. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. Skin Toxicity. Rash occurred in 91% of 74 pediatric patients. The most frequent rashes included dermatitis acneiform (54%), maculopapular rash (39%), and eczema (28%). Grade 3 rash occurred, in addition to rash resulting in dose interruption or dose reduction. Monitor for severe skin rashes. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. Increased Creatinine Phosphokinase (CPK). Increased CPK occurred, including Grade 3 or 4 resulting in dose reduction. Increased CPK concurrent with myalgia occurred, including one patient who permanently discontinued KOSELUGO for myalgia. Obtain serum CPK prior to initiating KOSELUGO, periodically during treatment, and as clinically indicated. If increased CPK occurs, evaluate for rhabdomyolysis or other causes. Withhold, reduce dose, or permanently discontinue KOSELUGO based on severity of adverse reaction. Increased Levels of Vitamin E and Risk of Bleeding. KOSELUGO capsules contain vitamin E which can inhibit platelet aggregation and antagonize vitamin K-dependent clotting factors. Supplemental vitamin E is not recommended if daily vitamin E intake (including the amount of vitamin E in KOSELUGO and supplement) will exceed the recommended or safe limits due to increased risk of bleeding. An increased risk of bleeding may occur in patients who are coadministered vitamin-K antagonists or anti-platelet antagonists with KOSELUGO. Monitor for bleeding in these patients and increase international normalized ratio (INR) in patients taking a vitamin-K antagonist. Perform anticoagulant assessments more frequently and adjust the dose of vitamin K antagonists or anti-platelet agents as appropriate. Embryo-Fetal Toxicity. Based on findings from animal studies, KOSELUGO can cause fetal harm when administered during pregnancy. In animal studies, administration of selumetinib to mice during organogenesis caused reduced fetal weight, adverse structural defects, and effects on embryo-fetal survival at approximate exposures >5 times the human exposure at the clinical dose of 25 mg/m2 twice daily. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with KOSELUGO and for 1 week after the last dose. ADVERSE REACTIONS Common adverse reactions ≥40% include vomiting, rash (all), abdominal pain, diarrhea, nausea, dry skin, musculoskeletal pain, fatigue, pyrexia, acneiform rash, stomatitis, headache, paronychia, and pruritus. DRUG INTERACTIONS Effect of Other Drugs on KOSELUGO Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inhibitor or fluconazole increased selumetinib plasma concentrations, which may increase the risk of adverse reactions. Avoid coadministration with KOSELUGO. If coadministration cannot be avoided, reduce KOSELUGO dosage. Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations, which may reduce KOSELUGO efficacy. Avoid concomitant use with KOSELUGO. SPECIAL POPULATIONS Pregnancy & Lactation. Verify the pregnancy status of patients of reproductive potential prior to initiating KOSELUGO. Due to the potential for adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with KOSELUGO and for 1 week after the last dose. About the AstraZeneca and Merck strategic collaboration In July 2017, AstraZeneca and Merck, known as MSD outside of the United States and Canada, announced a global strategic collaboration to co-develop and co-commercialize LYNPARZA (olaparib), a first-in-class PARP inhibitor, and KOSELUGO. Working together, the companies will develop LYNPARZA and KOSELUGO in combination with other potential new medicines and as monotherapies. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/ . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information and Patient Information (Medication Guide) for KOSELUGO (selumetinib) at https://alexion.com/Documents/koselugo_uspi.pdf

Clinical ResultPhase 3License out/inOrphan DrugDrug Approval

31 Oct 2024

·www.prnewswire.com

Lipocine Announces Distribution and License Agreement with SPC Korea to Commercialize TLANDO® in South Korea

SALT LAKE CITY, Oct. 31, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced a license, development and supply agreement with to SPC Korea granting exclusive rights to market TLANDO® in South Korea. Under the terms of the distribution and license agreement, Lipocine will receive an upfront payment and is also eligible to receive certain regulatory and sales milestone payments, including a payment upon regulatory approval of TLANDO in South Korea. Lipocine is entitled to royalties on net commercial sales. Lipocine will supply TLANDO to SPC Korea and will receive a supply price. SPC Korea will assume responsibility for obtaining regulatory approval within the territory. "We are very pleased to partner TLANDO with SPC Korea," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "This license agreement represents a strategic opportunity to expand the global reach of TLANDO and to address the significant unmet medical need in South Korea. It underscores Lipocine's commitment to strategic partnerships that have the potential to drive growth and create value for our shareholders while advancing our goals to deliver innovative therapies to patients." About TLANDO TLANDO is approved by the US FDA as a testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). It was developed using Lipocine's proprietary Lip'ral drug delivery technology platform. For full prescribing information, please visit . About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary combination of anabolic androgen receptor agonist and α-tocopherol, an antioxidant, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in chronic weight management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for chronic weight management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategic plans for developing products, our ability to monetize product candidates, including through entering into partnering arrangements, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug Approval

28 Oct 2024

·www.prnewswire.com

Cocrystal Health Industry Announces Launch of Best in Class Bioabsorption and Stability Cocrystallized Lutein and Curcumin Technologies

Patented and clinically verified nutraceutical actives outperform current branded offerings and offer a powerful solution for supplement product potency concerns. LAS VEGAS, Oct. 28, 2024 /PRNewswire/ -- At the Supplyside West tradeshow this week representatives from Cocrystal Health Industry are announcing the launch of the Cocrystal Lutein and Curcumin powder actives. Backed by 60 global patents and near 100 published papers, the company leverages their proprietary and clean cocrystallization platform to produce actives with dramatically improved bioabsorption, stability and functionality relative to existing offerings. These launches build on their existing cocrystallized ingredient portfolio which includes Ubiquinol CoQ10, Hydroxytyrosol and Alpha Tocopherol Vitamin E. Continue Reading Cocrystal Curcumin Powder Cocrystal Lutein Powder Lutein is well demonstrated in clinical research to support eye health, though traditional lutein ingredients have poor bioabsorption, solubility, and stability, as the ingredient is easily oxidized. Powered by Cocrystal Health Industry's clean, vegan and non-GMO cocrystallization process, Cocrystal Lutein now provides a powerful solution to address these concerns. In 3rd party testing, Cocrystal Lutein demonstrated over 6 times greater bioabsorption and 3 times better solubility compared to current marketed lutein. In a head-to-head capsule stability study, the cocrystal advantage is even more dramatic. Cocrystal Lutein maintained over 99% of potency in capsules after 30 days, while current marketed lutein maintained less than 2% of its original potency. In addition to performance advantages, the cocrystal technology offers a significant cost savings relative to well known branded lutein. While well researched to support a range of benefits including joint and cognitive health, marketed curcumin extracts are similarly limited by very poor bioavailability. Patented Cocrystal Curcumin featuring L-Carnitine as a ligand has been shown in studies to offer over 10X greater bioabsorption in comparison to current marketed curcumin. And while there are several enhanced bioavailability curcumin materials available, in a head-to-head study Cocrystal Curcumin showed significantly better bioabsorption even relative to an existing enhanced offer. Alex Mei, PhD, Cocrystal Health Industry's Founder & CEO commented, "We are thrilled to expand our portfolio and introduce powerful new solutions in our Cocrystal Lutein & Curcumin technologies. Our proprietary platform solves for multiple nutrition brand concerns – providing meaningful differentiation and unparalleled benefit performance to their consumers, while ensuring sustained potency against label claim. As the global leader in cocrystallized active ingredients, we're proud to offer these transformative solutions." To learn more manufacturers and formulators can reach out to [email protected]. About Cocrystal Health Industry: Backed by 60 global patents and near 100 published papers, Cocrystal Health Industry introduces cocrystal powder technologies as unprecedented solutions for poor stability and low bioavailability ingredients. With demonstrated best in class bioavailability and superior in-formula stability, our actives also feature pure nature integrity, improved solubility, dissolution, melting point and flowability versus existing offerings. Beyond their superior performance, Cocrystal actives typically offer a cost advantage relative to other branded ingredients. The company's growing portfolio includes Cocrystal Ubiquinol, Hydroxytyrosol, Alpha Tocopherol, Rutin and now Lutein and Curcumin. For more information visit . Media Contact: Jeff Avila 305-632-1733 [email protected] SOURCE Cocrystal Health Industry WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Vitamin E

External Link

KEGG	Wiki	ATC	Drug Bank
-	Vitamin E	A11HA03	DB00163

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Vitamin E Deficiency	CA	-	-
Vitamin E Deficiency	GB	-	-
Vitamin E Deficiency	CN	Sinopharm Group Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASTRO	Not Applicable	Pneumonia	-	Pentoxifylline and Vitamin E	(hnmmzrpibj) = wymzfzjmvt fzexlojvxh (wauvfibjsp )	-	01 Oct 2023
ESC2023	Not Applicable	Kidney Failure, Chronic	-	Non-vitamin K antagonist oral anticoagulants (NOACs)	(txrojnabos) = bzfvfpqtzz oaojjbyvmu (pblescveqg ) View more	-	28 Aug 2023
				Warfarin	(txrojnabos) = idnjyvmqlg oaojjbyvmu (pblescveqg ) View more
NCT03669133 (CTgov)	Phase 2	Nonalcoholic Steatohepatitis \| HIV Infections	3	Vitamin E (Group A)	actgbtpurk(imlisvxthg) = siqhotielq qusfttwgrr (edsexfmeqw, atqfywxqfn - oogbelthcb) View more	-	25 Jul 2023
				Placebo (Group B)	actgbtpurk(imlisvxthg) = vtmyifdiiu qusfttwgrr (edsexfmeqw, umpxionzsp - fpyxyjgped) View more
AHNS2023	Not Applicable	Stomatitis	-	?-tocopherol (Cinnamaldehyde)	epmlbrtplf(mwaaufvqgm) = ikbpcvgreu vgqlzlnshb (hzsnuyqltr )	-	08 Jul 2023
				α-tocopherol	epmlbrtplf(mwaaufvqgm) = ujhcrrptpf vgqlzlnshb (hzsnuyqltr )
NCT04198805 (PUVENAFLD, CTgov)	Phase 2	Insulin Resistance \| Nonalcoholic Steatohepatitis \| Hypertension	205	Omega-3 fatty acid+Vitamin E (DHA EE (1.89 g) and Vitamin E (1000 mg))	zaxjbkanrs(extnjgtelj) = pzxvojsegk ncyzlppgii (nevhuyvfpf, zapcmglixg - hiolbkgofo) View more	-	25 May 2023
				Placebo (Placebo)	zaxjbkanrs(extnjgtelj) = znlydpnfun ncyzlppgii (nevhuyvfpf, zwjbhbxdxl - mhgquivqkx) View more
ESC2022	Not Applicable	Aortic Valve Stenosis	38	Non-vitamin K antagonist oral anticoagulants (NOACs)	twqleaqxnu(qahubnyssl) = yhpkzwrsmr vpjjgtubxs (uvsmhqbvrs ) View more	-	29 Aug 2022
				Non-vitamin K antagonist oral anticoagulants (NOACs)	twqleaqxnu(qahubnyssl) = pbmcjrdxoy vpjjgtubxs (uvsmhqbvrs ) View more
ESMO_ASIA_VIRTUAL2020	Not Applicable	Mucositis	171	Vitamin E	shlmijchco(ngvlqxklkd) = there were no severe adverse effects reported in the studies rhgrvinltw (rknzfygybn ) View more	Positive	22 Nov 2020
				Placebo
NCT00862433 (Pubmed \| Am J Clin Nutr)	Phase 1	-	50	Vitamin E (600-kcal DLM with 40% fat)	qqzxntomaj(etpmjpzujo) = uhnecmowhc ddyilbiqqn (bjnhoidhgk, ± 3)	-	01 Nov 2019
				Vitamin E (600-kcal DLM with 0% fat)	qqzxntomaj(etpmjpzujo) = penhtlrivj ddyilbiqqn (bjnhoidhgk, ± 3)
NCT02100228 (EMANATE, Pubmed \| Eur Heart J)	Phase 4	Atrial Fibrillation	1,500	Apixaban	(xxhjcyyhnm): RR = 1.98 (95% CI, 0.19 - 54) View more	Positive	21 Aug 2018
				Heparin/Vitamin K Antagonist

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