Veregen (sinecatechins) / Sinphar Pharma, Medigene - LARVOL DELTA

Growth responses of Aspergillus and Penicillium species under modified atmospheric conditions: An in vitro and partially baked roll study. (PubMed, J Food Sci) - "Growth of P. crustosum SB20 and P. paneum SB14; and A. clavatus SB03 and A. oryzae SB02 on partially baked rolls was delayed by 7 and 14 days, respectively, under 80% CO2 and 20% O2 compared to normal atmosphere...PRACTICAL APPLICATION: The influence of CO2 on the growth and sporulation of mold varies depending on the tested strain and species. To analyze the effects of packaging conditions (modified atmosphere packaging or O2 scavengers) on the mold-free shelf-life of bakery products/food products, it is essential to utilize molds that have been isolated from either the product being tested or the manufacturing environment."

Journal • Preclinical

Effectiveness of electrocautery, topical cidofovir and topical sinecatechins for the Treatment of Anal High-grade Squamous Intraepithelial Lesions in Persons with HIV: an open-label, randomized controlled trial. (PubMed, Clin Infect Dis) - P3 | "No statistically significant difference was observed in efficacy between treatments; in contrast, sinecatechins was the most accepted and well-tolerated treatment."

Journal • Anal Carcinoma • Human Immunodeficiency Virus • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Genital Warts: Rapid Evidence Review. (PubMed, Am Fam Physician) - "All treatment strategies are associated with some recurrence, but most successfully treated warts do not recur. Use of podofilox, imiquimod, and sinecatechins should be avoided in pregnancy."

Journal • Review • Dermatology • Oncology

Condylomata Acuminata Successfully Treated with Topical Glycyrrhizic Acid after Failure Treatment of 80% Trichloroacetic Acid and 25% Podophyllin : A case report (EADV 2024) - "There are developing herbal medicines used to treat CA such as sinecatechins ointment and glycyrrhizic acid solution... Glycyrrhizic acid topical is a simple, safe, effective, and patient friendly in treating genital warts. It can be regarded as an alternative therapy for CA. It can be used if standard therapy cannot give good clinical response or as a combination home therapy."

Case report • Clinical • Dermatology • Human Immunodeficiency Virus • Infectious Disease • Oncology

Early exposure to phosphorus starvation induces genetically determined responses in Sorghum bicolor roots. (PubMed, Theor Appl Genet) - "Association studies identified quantitative trait loci in chromosomes Sb02, Sb03, Sb04, Sb06 and Sb09 linked with genes potentially involved in P transport and stress responses. The genetic dissection of key factors underlying RSA responses to P deficiency could enable early identification of P-efficient sorghum genotypes. Genotypes with interesting RSA traits for low P environments will be incorporated into current sorghum breeding programs for later growth stages and field-based evaluations."

Journal

TreatAIN: Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males (clinicaltrials.gov) - P3 | N=108 | Completed | Sponsor: Hospital Universitari Vall d'Hebron Research Institute | Unknown status ➔ Completed | Trial completion date: Apr 2022 ➔ Jul 2024 | Trial primary completion date: Sep 2021 ➔ Jan 2024

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Oncology

Protective effects of several tyndallized probiotics against UVs‑induced photodamage in epidermal keratinocytes cells (EADV-Sp 2024) - "Materials & The present work explores the potential of five tyndalized probiotics (Lactiplantibacillus plantarum SKINBAC™ SB01, Limosilactobacillus reuteri SKINBAC™ SB02, Bifidobacterium breve SKINBAC™ SB03, Ligilactobacillus salivarius SKINBAC™ SB04, and Bifidobacterium animalis spp... With this work we aim to contribute valuable insights that may pave the way for innovative skincare strategies centered around probiotic-based formulations for enhanced skin protection against UV-induced damage."

Dermatology • Genetic Disorders • Oncology • Skin Cancer • CDH1 • CLDN1 • CLDN4 • HMOX1 • IL6 • OCLN

Treatment of Pediatric Anogenital Warts in the Era of HPV-Vaccine: A Literature Review. (PubMed, J Clin Med) - "Among available therapies for AWs, topical therapies, such as immunomodulating-agents (topical imiquimod 5% and 3.75% cream, sinecatechins 15% ointment) and cytotoxic agents (podophyllotoxin and cidofovir) are considered manageable in children because of their low aggressiveness. In particular, podofillotoxin gel 5% and imiquimod 5% cream have been reported to be safe and efficacious in children. Currently, HPV vaccination is not recommended as a treatment for established HPV infection and AWs, yet a possible therapeutic role of HPV vaccination was recently suggested in the literature and deserves mention."

Journal • Review • Dermatology • Human Papillomavirus Infection • Immune Modulation • Infectious Disease • Pediatrics

Tirbanibulin 1% ointment – a potential new treatment option for recurrent anogenital warts (WCD 2023) - "OBSERVATIONS: All our patients suffered from recurrent AGW in the genito-anal area for several years and had undergone multiple surgical therapies and topical treatments with imiquimod, trichloroacetic acid, podophyllotoxin and sinecatechins. KEY MESSAGE: Due to its short application time and mild local skin reactions, tirbanibulin may represent a new first-in-class treatment for AGW. Especially patients with chronic recurrent lesions could benefit from the therapy in a home application"

Actinic Keratosis • Dermatology • Inflammation • Pain

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial completion date: Jun 2026 ➔ Dec 2032 | Trial primary completion date: Jun 2026 ➔ Dec 2032

Biomarker • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial completion date: Oct 2024 ➔ Jun 2026 | Trial primary completion date: Oct 2024 ➔ Jun 2026

Biomarker • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Recent advances in chemical composition and transdermal delivery systems for topical bio-actives in skin cancer. (PubMed, Curr Top Med Chem) - "The most commonly used topical agents for treating skin carcinoma are- 5-fluorouracil, imiquimod, sonidegib, dacarbazine, etc. However, drug physicochemical characteristics and skin physiological barriers limit the anticancer potency of topical as well as transdermal drug delivery. In particular, significant studies have been made, including modification of bio-actives, permeability enhancers, incorporation of advanced nano and microcarriers, and physical enhancement devices. This critical review summarizes the advancement in the chemical composition of bioactives used in skin cancer, such as sinecatechins, BIL-010t, patidegib, gingerol, curcumin, remetinostat, epigallocatechin-3-gallate, etc. Furthermore, this review, specifically addresses the progress in transdermal delivery systems for melanoma and non-melanoma cancer therapy, emphasizing advances in physical and chemical penetration enhancement and nanocarrier-assisted transdermal systems."

Journal • Basal Cell Carcinoma • Genetic Disorders • Non-melanoma Skin Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

Inhibition of Cell Proliferation and Cell Viability by Sinecatechins in Cutaneous SCC Cells Is Related to an Imbalance of ROS and Loss of Mitochondrial Membrane Potential. (PubMed, Antioxidants (Basel)) - "Thus, sinecatechins inhibited cell proliferation and viability of cSCC cells, which could suggest the use of PE for AK treatment. The mechanisms appear as linked to an imbalance of ROS levels."

IO biomarker • Journal • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • BCL2 • CASP3

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring (clinicaltrials.gov) - P2; N=360; Recruiting; Sponsor: ECOG-ACRIN Cancer Research Group; Not yet recruiting ➔ Recruiting

Biomarker • Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MRI

Drugs for sexually transmitted infections. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology • Infectious Disease

Specialty molecules from plants and in vitro cultures as new drugs: regulatory considerations from flask to patient. (PubMed, Plant Cell Tissue Organ Cult) - "Few therapeutic specialty molecules from in vitro cultures beyond paclitaxel have come to market and although other more complex products like ginseng have also appeared, success has been limited. Here we discuss broader thinking of such specialty molecules in the form of dietary supplements, nutraceuticals, herbal medicines, botanical drugs, and pure molecules along with potential complex products from a regulatory standpoint and especially within the realm of approved botanical drugs, e.g., Veregen and Fulyzaq, that have new drug applications (NDAs). The United States food and drug administration (US FDA) regulatory categories are used to provide examples of alternative product options that could prove useful for taking specialty molecules to market."

Journal • Preclinical

Asian guidelines for condyloma acuminatum. (PubMed, J Infect Chemother) - "1. Vaccination (LE: 1a): Quadrivalent vaccine reduced the frequency of anogenital warts in both vaccinated and unvaccinated contacts. According to the update Advisory Committee on Immunization Practices (ACIP) recommendations, the following protocol is recommended: (a). HPV vaccination at age 11 or 12 years for both males and females. (b). Catch-up vaccination for all persons through age 26 years. (c). Shared clinical decision-making regarding potential HPV vaccination for persons aged 27-45 years, who are at risk of new HPV infection. 2. Male circumcision (LE: 2a): conflicting evidence."

Journal • Dermatology • Human Immunodeficiency Virus • Infectious Disease • Oncology

Assessment of sinecatechins 10% ointment used as proactive sequential therapy in recurrence rate of genital warts lesions after cryotherapy. The PACT-II Trial (postablation immunomodulator treatment of condylomata with sinecatechins): a prospective assessor-blinded, multicenter, pilot trial. (PubMed, Ital J Dermatol Venerol) - "The PACT-II Trial has shown that the recurrence rate of EGW lesions after successful cryotherapy using sinecatechins as immunomodulator sequential therapy is lower in comparison with the percentage documented in the literature without sequential therapy (20 vs. 45%). These results are in line with already published data evaluating the role of sinecatechins after laser therapy (PACT-I trial). Future comparative, double-blind controlled trials assessing the efficacy of different proactive strategies are warranted."

Journal • Dermatology • Immune Modulation • Immunology • Inflammation

An explainable Artificial Intelligence approach to study MCI to AD conversion via HD-EEG processing. (PubMed, Clin EEG Neurosci) - "The procedure allowed to detect which EEG-channels (i.e., head region) and range of frequencies (i.e., sub-bands) resulted more active in the progression to AD. The xAI analysis showed that the main information is included in the delta sub-band and that, limited to the analyzed dataset, the highest relevant areas are: the left-temporal and central-frontal lobe for Sb01, the parietal lobe for Sb02, the left-frontal lobe for Sb03 and the left-frontotemporal region for Sb04."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Immunology

Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment (clinicaltrials.gov) - P2; N=32; Terminated; Sponsor: GTO Pharmaceutical, LLC; N=60 ➔ 32; Trial completion date: Sep 2021 ➔ Feb 2021; Recruiting ➔ Terminated; Trial primary completion date: Jul 2021 ➔ Feb 2021; pandemic

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Gynecology • Musculoskeletal Pain • Pain • Sexual Disorders • Vaginal Atrophy • Women's Health

The effectiveness of intralesional Candida antigen immunotherapy as a treatment for anogenital warts: a retrospective chart review. (PubMed, J Eur Acad Dermatol Venereol) - "Human papillomavirus (HPV) is a reproductive tract infection that causes anogenital warts (AGW).(2) Among the 100 strains of HPV,(1) HPV6 and 11 cause 90% of AGW.(2) AGW have a significant disease burden; a global systematic review showed a median annual incidence of 194.5 cases per 100 000 in 2013.(3) Several treatments exist for AGW: imiquimod, 5-fluorouracil, cryotherapy, salicylic acid, sinecatechins, trichloroacetic acid, lasers and surgery. Immunotherapy with intralesional Candida antigen (CA) is a growing treatment for warts, however, limited clinical literature exists on effectiveness in AGW. CA offers an efficient, easy and systemic approach to managing warts."

Journal • Retrospective data • Review • Dermatology • Infectious Disease • Oncology

Inhibition of cell proliferation and cell viability by Polyphenon E (Veregen) in cutaneous SCC cell lines (ADO 2021) - "Thus, the inhibitory effects of PE on cSCC cells are based on inhibition of cell proliferation and reduced cell viability, and may suggest the use of Veregen for treatment of actinic keratosis. The mechanisms appear as further related to downregulation of ROS."

Preclinical • Actinic Keratosis • Dermatology • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring (clinicaltrials.gov) - P2; N=360; Not yet recruiting; Sponsor: ECOG-ACRIN Cancer Research Group; Initiation date: Jan 2021 ➔ May 2021

Biomarker • Clinical • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] Extensive Eyelid Molluscum Treated With Carbon Dioxide Laser (CDA-I 2020) - "The former was untreated and the latter was managed with topical tacrolimus 0.1% ointment...His previous treatments included imiquimoid 5% cream, sinecatechins 15% cream, and cyrotherapy applied using a cotton tip. These therapies did not yield any clinical improvement and he was unable to afford topical cidofovir therapy. Methods, Results The patient was treated with carbon dioxide laser therapy as follows...Under 2 cc of 1% lidocaine with epinephrine (1:100 000), individual lesions were targeted with a single pass of ablative carbon dioxide laser (Lumenis Ultrapulse) at the following settings: 125 mJ and 1.5 W. At his two month follow-up, the few remaining lesions were treated with the aforementioned protocol. At his three-month follow-up, the patient had complete resolution of his lesions without recurrence or side effects. Conclusions This is the first report of ablative carbon dioxide laser treatment for extensive eyelid MC. The ablative nature..."

Atopic Dermatitis • Conjunctivitis • Dermatitis • Dermatology • Dermatopathology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Ocular Inflammation • Ophthalmology • Sarcoidosis

Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single center double-blind randomised control study. (PubMed, BJOG) - "Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study."

Clinical • Journal • Gynecologic Cancers • Oncology • Pain