A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients with Actinic Keratosis of the Scalp and the Face. - Pro_VER-01-21_AR

Start Date04 Sep 2024

Sponsor / Collaborator

Aresus Pharma GmbH

NCT04597359

/ RecruitingPhase 2IIT

A Phase II Randomized Double Blinded Study of Green Tea Catechins (GTC) vs. Placebo in Men on Active Surveillance for Prostate Cancer: Modulation of Biological and Clinical Intermediate Biomarkers

This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.

Start Date05 Oct 2021

Sponsor / Collaborator

ECOG-ACRIN Medical Research Foundation, Inc.

[+1]

NCT04055142

/ CompletedPhase 3IIT

A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups 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

This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN).
The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males.
All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

Start Date18 Sep 2020

Sponsor / Collaborator

Vall DHebron University Hospital

100 Clinical Results associated with Sinecatechins

100 Translational Medicine associated with Sinecatechins

100 Patents (Medical) associated with Sinecatechins

124

Literatures (Medical) associated with Sinecatechins

01 Feb 2025·AMERICAN FAMILY PHYSICIAN

Genital Warts: Rapid Evidence Review.

Review

Author: Brus, Janelle M ; Larker, Jackeline C L ; Temple, Richard W

Genital warts (also referred to as anogenital warts and condyloma acuminatum) are caused by human papillomavirus types 6 and 11 in 90% of cases. They are transmitted primarily through anogenital contact and penetrative and non-penetrative sex. Transmission can be effectively prevented with vaccination. Current evidence regarding the effects of condom use on the prevalence of genital warts is conflicting. In the United States from 2013-2016, the prevalence of genital warts among individuals ages 18 to 59 years was 1.3% in men and 3.1% in women. The diagnosis is made clinically by the appearance of single or multiple lesions that may coalesce or be the same color as surrounding skin, cauliflower-like, flat, papular, or keratotic. Biopsy is indicated in some cases, such as for atypical lesions. Treatment may be patient- or physician-administered, with choice of treatment informed by shared decision-making. Treatment options may be limited by physician skills and clinic availability. Podofilox 0.5% solution is the most effective patient-administered therapy and carbon dioxide laser therapy, surgery, and electrosurgery are the most effective for wart removal at the end of treatment. 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.

01 Jan 2023·Current topics in medicinal chemistry

Recent Advances in Chemical Composition and Transdermal Delivery Systems for Topical Bio-actives in Skin Cancer

Review

Author: Ghosh, Goutam ; Rath, Goutam ; Kar, Biswakanth ; Halder, Jitu ; Mishra, Ajit

Abstract::

Skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma, is conventionally treated by surgery, phototherapy, immunotherapy, and chemotherapy. For decades, surgical removal of malignant cancers has favored patients' therapeutic options. However, multiple aspects, such as the patient's comorbidities, the anatomical location of the lesion, and possible resistance to recurrent excisions, can influence the decision to conduct surgery. Therefore, topical and transdermal therapy may be a more appropriate option, allowing for higher therapeutic levels at the site of action and reducing toxicity than systemic therapy. 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 recent years, unquestionable signs of progress have been demonstrated to circumvent these challenges. 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.

01 Jul 2022·Journal of infection and chemotherapy : official journal of the Japan Society of ChemotherapyQ4 · MEDICINE

Asian guidelines for condyloma acuminatum

Q4 · MEDICINE

Review

Author: Sindhuja, Tekumalla ; Bhari, Neetu ; Gupta, Somesh

METHODOLOGY:

A PubMed search was performed, using the keywords "condyloma acuminata", "anal wart", "anogenital wart", "genital wart" and "genital HPV". A total of 3031 results were found in publications during last six years. A careful review of the titles and abstracts was done to find all the studies pertaining to epidemiology, clinical features, diagnosis, treatment and prevention of condyloma acuminata.

DIAGNOSIS:

Various diagnostic procedures described are: 1. PCR (LE: 2b). 2. Serology (LE: 2b). 3. In-situ hybridization (LE: 3).

PREVENTION:

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.

HIV AND CONDYLOMA ACUMINATA:

In HIV-affected individuals, the course of HPV is more aggressive, with a greater risk of treatment resistance, increased chances of intraepithelial neoplasia as well as cancers.

TREATMENT:

Physician administered. 1. Photodynamic therapy (LE: 1a). 2. Laser (LE: 2b). 3. Surgery (LE: 1a). 4. Electrosurgery (LE: 2c). 5. Cryotherapy (LE: 1b). 6. Immunotherapy (LE: 1b). 7. Podophyllin (LE: 1b). Provider administered. 1. Imiquimod 5%(LE: 1a). 2. Podophyllotoxin (LE: 1b). 3. Sinecatechins (LE: 1a). 4. Cidofovir (LE: 3). 5. 5- Fluorouracil (LE: 1a). 6. Interferon (LE: 1a).

News (Medical) associated with Sinecatechins

30 May 2023

·www.drugs.com

HPV: What It Is, Symptoms in Men vs. Women & Treatment

TUESDAY, May 30, 2023 -- Talking about sexually transmitted infections (STIs) can be uncomfortable. But whether you’re talking to your partner, child or doctor, these are important conversations to have. The U.S. Centers for Disease Control and Prevention estimates 20% of Americans had an STI in 2018. There are still more undetected, unreported and untreated STIs that can result in “serious health consequences.” Human papillomavirus (HPV) is the most common STI in the United States, so it’s important to know the facts. What is HPV? The CDC reports there were 43 million HPV infections in the United States in 2018. It’s a virus, and Mayo Clinic says it’s so widespread that an estimated 85% of all people will become infected with HPV in their lifetime. Dr. Nipunie Rajapakse , a Mayo Clinic pediatric infectious diseases physician, said in a recent article that "the scary thing about this virus is that it also is a virus that can cause cancer." The U.S. National Cancer Institute (NCI) explains HPV and cancer this way: There are over 200 viruses related to HPV. Sexually transmitted HPV is separated into low-risk HPV and high-risk HPV. High-risk HPV, specifically HPV-16 and HPV-18, is responsible for a majority of HPV-related cancers. How do you get HPV? HPV spreads through close, intimate contact with someone infected with the virus. This includes vaginal, anal and oral sex, or skin-to-skin contact. Anyone who is sexually active can contract the virus. According to Mayo Clinic , you’re at a higher risk for contracting sexually transmitted HPV if you: have multiple sexual partners are an adolescent or a young adult have a weakened immune system HPV symptoms It’s common for a person, male or female, to be infected with HPV and not have any symptoms at all. However, the CDC warns an asymptomatic person with HPV can still infect someone else. There are certain strains of HPV that can cause symptoms like genital warts or even cancer. HPV in women: Mayo Clinic explains genital warts are small bumps, brown or pink in color, found on the vulva, vaginal walls, anus or cervix. They can also appear in the mouth or throat. Genital warts can cause itching and discomfort, as well as bleeding with intercourse. The NCI says long-term, high-risk HPV can infect cells and cause cancer of the cervix. They recommend regular cervical cancer screenings for early detection. High-risk HPV can also cause cancer of the oropharynx, vagina, anus and vulva. Itching and bleeding are signs of a precancerous lesion. HPV in men: Men can also develop genital warts that are similar in appearance. For men, genital warts can develop on the penis, scrotum, anus, and the mouth and throat. There’s also a cancer risk for men with high-risk HPV. Left untreated over a long period of time, the virus can modify cells and develop into cancer. This includes penile, anal and oropharyngeal cancer. HPV treatment There’s no treatment for HPV; however, treatment is available for health problems that develop as a result of contracting it. For genital warts, your health care provider can prescribe topical medications. Prescription medications such as imiquimod (Aldara, Zyclara) and sinecatechins (Veregen) are commonly used for treating genital warts, according to the Mayo Clinic . There are U.S. Food and Drug Administration-approved cervical cancer screenings that can detect high-risk HPV in cervical cells. There’s also a Pap test that can identify precancerous cell changes. NCI says early detection is important. HPV prevention To reduce your risk of contracting HPV, the CDC offers a few suggestions. First, being in a monogamous sexual relationship and talking to your partner about his or her sexual history before having sex can lower your risk. Condoms and dental dams can also help reduce your risk of contracting HPV, but neither provides 100% protection from the virus. Another preventive measure is the HPV vaccine GARDASIL 9. This vaccine has significantly lowered HPV infections and cervical pre-cancers in girls and young women, according to the CDC . "This is a really effective, really safe vaccine that is unique because it is a vaccine that prevents cancer,” Rajapakse said. She says the HPV vaccine is recommended for 11- and 12-year-old boys and girls, but it can be given to children as young as 9. Ideally, a child or young person should be vaccinated before they become sexually active. The vaccine is not recommended for anyone older than 26 since they’ve likely already had exposure to HPV. The vaccine might not be effective when given to someone already infected with HPV. Knowing the facts about HPV can help you make informed decisions about prevention and treatment. Talk to your health care provider if you’re concerned about exposure to human papillomavirus or for more information about the HPV vaccine. Posted May 2023

Vaccine

09 Apr 2019

·www.biospace.com

Medigene AG: Medigene sells remaining rights and inventories of Veregen® to Aresus Pharma

Aresus takes over Veregen® business including API stock and intends to invest in expanding Veregen® into indications and markets Planegg (pta/08.04.2019/16:25) Aresus takes over Veregen® business including API stock and intends to invest in expanding Veregen® into indications and markets Sale of non-core product Veregen® completes Medigene’s transformation into a pure immunotherapy company Medigene AG (FSE: MDG1, Prime Standard) sells its remaining rights to the dermatological drug Veregen® and its complete stock of the corresponding active pharmaceutical ingredient (API) to the pharmaceutical company Aresus Pharma GmbH (“Aresus”), Munich, Germany. In the course of the sale, all existing relevant contracts with distribution partners and external service providers will be transferred from Medigene to Aresus. Medigene had sold the US rights to the drug at the end of 2017 to the US company Fougera Pharmaceuticals Inc. With this sale of its last product from its “non-core business”, Medigene AG completes the transformation into a pure immunotherapy company. Prof. Dolores Schendel, Chief Executive Officer and CSO of Medigene AG , comments: “Since Medigene’s refocusing on cellular immunotherapy, the skin drug Veregen® no longer fits into our strategic position. We are very pleased that following the sale of US rights, we will now be able to hand over the remaining rights to this product to a company lead by dermatology product and clinical trial specialists. This will now allow us to focus fully on the advancement of our immuno-oncological cell therapies.” Dr. Francisco Harrison, Director of Aresus Pharma GmbH: “We are excited to built-up Aresus as a dynamic dermatology company focusing on the further commercialization and clinical research of Veregen®. This product has various potentials to be explored and we intend to invest in expanding Veregen® into further indications and markets.” Medigene will receive up to approximately EUR 7.75 million from Aresus for the remaining Veregen® rights and all existing API stock. Therefrom, Medigene receives EUR 300.000 upfront and the balance within the next ten years as annual revenue-based earn-out payments from 2021 onwards. These expected payments are recognized as receivables and discounted in accordance with International Financial Reporting Standards (IFRS) and due to the measurement method of the receivable at the date of the transaction. Therefore, Medigene’s EBITDA will be affected by a non-cash effective loss between EUR 4 and 5 Mio. In the future, this non-cash effective loss will be compensated by corresponding interest income as the payment period becomes continuously shorter. Medigene will update its financial guidance with respect to revenue and EBITDA with issuing its quarterly statement. The closing of the transaction including the transfer of rights is planned for mid-April 2019. Veregen® is an ointment for the local treatment of external genital and perianal warts (Condylomata acuminata). About Aresus Pharma: Aresus Pharma GmbH is a new company, that will focus on the further global commercialization and clinical development of Veregen®. The company founders Mr. Sven Schimansky-Wabra and Dr. Francisco Harrison are an experienced team with a sound background in dermatology and clinical research who have an additional company portfolio for the development and commercialization of other semi-solid products as well as a company that specializes in regulatory affairs services. More information at: About the Aresus founders: Dr Francisco Harrison is an MD, who built a global CRO company over a span of 25 years. Up to 2012, Harrison Clinical Research Group, today operating under Synteract, covered all clinical phases and employed over 500 people in 16 countries. Later, Harrison established a new group of service companies for the Life Science community under the HCSTH holding: Idea Regulatory in the regulatory area, Rephine for quality assurance and Hureka Resources providing healthcare investment advice and management. The new venture Aresus Pharma will be devoted to prescription dermatological products of natural origin. More information at: Sven Schimansky-Wabra has been working in the pharmaceutical sector since 2004, starting his career at Schering, later Intendis Dermatologie and Bayer. In 2012, he left Bayer to set up Skin Care Pharma. Skin Care developed Skinatan®, the generic version of Advantan®, and brought it successfully through the approval studies. Furthermore, Sven Schimansky-Wabra is also involved in the company Degode-Dermago Development where he had developed Beloren®, a generic version of Skinoren®. More information at: Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, SDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with the focus on T cell receptor-modified T cells (TCR-Ts) and has projects currently in preclinical and clinical development. For more information, please visit This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Contacts Medigene AG Julia Hofmann, Dr. Robert Mayer Tel.: +49 - 89 - 20 00 33 - 33 01 email: investor@medigene.com Aresus Pharma GmbH Email: info@aresus.de

ImmunotherapyExecutive ChangeLicense out/inAcquisition

100 Deals associated with Sinecatechins

External Link

KEGG	Wiki	ATC	Drug Bank
D08997	Sinecatechins	D06BB12	DB01266

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Condylomata Acuminata	United States	ANI Pharmaceuticals, Inc.	31 Oct 2006

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03682601 (CTgov)	Phase 2	Sexual Dysfunctions, Psychological \| Female sexual dysfunction \| Vulvovaginal atrophy ... View more	32	Placebo (Placebo)	pxgmikxmpq(skkslxwgiv) = tpasrpuvie jvfsidemme (cuesipaqnn, 0.3) View more	-	28 Jun 2022
				5% sinecatechins ointment (5% Topical Sinecatechins Ointment)	pxgmikxmpq(skkslxwgiv) = znxhivxnxx jvfsidemme (cuesipaqnn, 0.5) View more
NCT02147353 (CTgov)	Not Applicable	Condylomata Acuminata	42	Cryotherapy alone+Sinecatechins 15% Ointment (Sinecatechins 15% Ointment & Cryotherapy)	wfxgarrctc = dazsongxdm lwmpnbbclq (bbabvptczx, luxuwjueni - nmreqjmqpt) View more	-	14 Jun 2019
				Cryotherapy alone (Cryotherapy Alone)	wfxgarrctc = aeylqpjjva lwmpnbbclq (bbabvptczx, auepgyuftc - utymcoffmy) View more
ISRCTN44037479 (PACT study, Pubmed \| Int J STD AIDS)	Phase 4	Condylomata Acuminata	87	Control group (no sequential therapy)	tkeqqfzwms(yzarnbxbav) = blybvcmxvg zhykgavawe (otmaoibzou )	-	01 Feb 2019
NCT00718094 (CTgov)	Phase 2	Colitis, Ulcerative	20	Polyphenon E® (Polyphenon E Treatment)	goyciglydz = xrjtpshzmu bwrevgiohf (nfomipmvrk, gjxrvkwxfc - ivozjogodi) View more	-	14 Dec 2017
				Placebo Oral Tablet (Placebo)	goyciglydz = marpfedozl bwrevgiohf (nfomipmvrk, cjxeatlyjf - ixrlhdsdbe) View more
NCT02622568 (CTgov)	Phase 4	Warts	28	Veregen only	bqymlqsaiy(gigihwqijr) = tscsozcogo lvwaipqrxp (ruqtpyxxkb, 3.9826) View more	-	08 Sep 2017
NCT02147353 (Pubmed)	Not Applicable	Condylomata Acuminata	42	Cryotherapy + Sinecatechins 15% ointment BID	bmsrpbkmnb(qguyhcthlm) = dhbggfsslx qdknftxhnj (bnlxxgnqxb )	-	01 Nov 2014
				Cryotherapy alone	bmsrpbkmnb(qguyhcthlm) = durwqejjcp qdknftxhnj (bnlxxgnqxb )
NCT00596011 (CTgov)	Phase 2	Prostatic Hyperplasia \| Prostatic Intraepithelial Neoplasia	97	Polyphenon E (Active Comparator: Polyphenon E Treatment)	wwrwcomnpw = vzttflwxiy ezeuufdmhi (xiqvkzcuiy, cufcwbhxjo - uzqwtyuiks) View more	-	03 Sep 2014
				Placebo (Placebo Comparator: Placebo Administration)	wwrwcomnpw = dluuhtyals ezeuufdmhi (xiqvkzcuiy, hyqyszxtau - mdluwnfrne) View more
NCT00676780 (CTgov)	Phase 2	Prostatic Cancer	33	Polyphenon E (EGCG)	nhpukngqic(sradxqjwsr) = gsxeromfzi llbgeilacv (myixqhohiw, dotybexehz - gxnkadlvyu) View more	-	08 Aug 2012

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