Jan 17, 2023 Clinical Trial
Relief Therapeutics Holding SA / Key phrase(s): Study
17-Jan-2023 / 06:56 CET/CEST
Release of an advert hoc announcement pursuant to Art. 53 LR
The issuer is solely liable for the content material of this announcement.
GENEVA, JAN. 17, 2023 – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), a biopharmaceutical firm figuring out, growing and commercializing novel, patent protected merchandise in choose specialty, uncommon and ultra-rare illness areas, introduced impartial institutional assessment board (IRB) approval for the protocol of an investigator-initiated trial to judge RLF-TD011 as an adjunctive remedy for sufferers recognized with cutaneous t-cell lymphoma (CTCL). The research will consider the impact of RLF-TD011, a patent-protected hypochlorous acid topical spray, on the microbiome of CTCL pores and skin lesions and decide tolerability, symptom enchancment, and potential for decreasing lesion dimension and pores and skin illness exercise.
The research will enroll contributors at Northwestern division of dermatology in Chicago. Microbiome assessments shall be carried out beneath the management of co-principal investigator Alan Zhou, M.D., MSc., fellow of the American Academy of Dermatology and assistant professor of dermatology at Northwestern University.
CTCL is a uncommon, heterogeneous group of non-Hodgkin's lymphomas by which malignant t-cells infiltrate the pores and skin. Advanced CTCL lesions harbor Staphylococcus aureus, which launch toxins that stimulate malignant cells and drive illness development. This typically results in recurrent pores and skin infections with a excessive danger for sepsis and dying.
"Treatment of superior CTCL stays a problem, with five-year disease-specific survival charges starting from 70 % for early stage to 24 % for superior illness, with the best mortality stemming from bacterial infections," stated Dr. Alan Zhou. "This proof-of-concept scientific research will take a look at the microbiome adjustments and scientific enchancment in 30 sufferers over an eight-week research interval. We will consider how the bactericidal exercise of this distinctive hypochlorous acid pores and skin spray, beforehand proven to kill methicillin-sensitive and methicillin-resistant Staphylococcus aureus, in addition to Pseudomonas aeruginosa—might enhance the CTCL microbiome to doubtlessly lower pruritus, erythema, scaling, lesion dimension and general pores and skin illness exercise, with the objective of delaying illness development and decreasing dying."
"This investigator-initiated trial represents an necessary step within the scientific improvement pathway of RLF-TD011," stated Nermeen Varawalla, M.D., D.Phil., M.B.A., chief medical officer, Relief Therapeutics. "Data from this research shall be utilized to facilitate the design and conduct of follow-on, multi-center, pivotal scientific trials, which is able to doubtlessly function the scientific assist for our eventual submissions to the U.S. Food and Drug Administration and European Medicines Agency for RLF-TD011 as an efficient, handy and well-tolerated remedy for CTCL, thereby addressing an necessary unmet medical want in an intractable, incurable illness."
ABOUT CUTANEOUS T-CELL LYMPHOMAS
Cutaneous t-cell lymphomas (CTCLs) are a uncommon group of issues referred to as non-Hodgkin's lymphomas characterised by irregular accumulation of malignant t-cells within the pores and skin that can lead to the event of rashes, plaques and tumors. Because CTCL is uncommon and infrequently appears to be like like eczema or one other widespread pores and skin illness, it may be troublesome to diagnose. While there are a lot of forms of CTCLs, the most typical diagnoses are mycosis fungoides, main CTCL and first cutaneous anaplastic massive cell lymphoma[1]. The general incidence price of CTCL was 8.55 per 1 million with MF being the subtype with the best incidence, at 5.42 per 1 million[2]. The general incidence of CTCL within the U.S. and Europe has elevated, a mirrored image of higher diagnostic instruments and elevated consciousness amongst physicians and sufferers, which has led to improved illness detection[3].
According to Fortune Business Insights, the North American CTCL therapeutics market dimension is projected to hit an annual valuation of USD $587.4 million by 2028, registering a 13.6 % compound annual development price (CAGR) within the 2021-2028 interval[4]. The market worth was estimated to be price USD $225.9 million in 2020 and reached USD $240.9 million in 2021. The growing burden of CTCL within the area is slated to extend the demand for novel CTCL therapeutics options. Cleveland Clinic reviews that greater than 3,000 new CTCL sufferers are recognized within the U.S. annually and about 16,000-20,000 people endure from mycosis fungoides, the most typical type of CTCL that's linked to skin-localized immune cell stimulation.
ABOUT RLF-TD011
RLF-TD011 was developed utilizing the TEHCLO® proprietary expertise and is a extremely pure and stabilized hypochlorous acid (HClO >95% of free chlorine species), with pH between 2.5 – 3.0 and excessive reduction-oxidation potential (ORP 1.000 – 1.200 mV). It is a self-administered, sprayable resolution enabling focused software whereas avoiding pores and skin contact and cross-contamination. RLF-TD011 has persistently been proven to speed up wound closure with decreased an infection charges in scientific trials[5],[6],[7]. If authorised on this indication, it is going to be the primary product particularly indicated to enhance the microbiome in CTCL leading to symptom management and halting illness development.
RLF-TD011 is presently registered beneath the model title Nexodyn® AcidOxidizing Solution (AOS) to be used within the debridement, irrigation, cleaning and moistening of power wounds and acute wounds, post-surgical wounds, cuts, abrasions, burns and different lesions. Nexodyn AOS is licensed within the EU as class III medical gadget and within the U.S., as a 510(okay) cleared unclassified gadget.
ABOUT RELIEF THERAPEUTICS Holding SA
Relief Therapeutics is a Swiss, commercial-stage, biopharmaceutical firm centered on identification, improvement and commercialization of novel, patent protected merchandise supposed for the remedy of uncommon and ultra-rare illnesses together with metabolic issues, pulmonary illnesses and connective tissue issues. Relief Therapeutic's diversified pipeline consists of property which have the potential to successfully deal with vital unmet medical wants, together with PKU GOLIKE®, engineered with the proprietary Physiomimic™ expertise, which is the primary prolonged-release amino acid product commercialized for the dietary administration of phenylketonuria (PKU). Relief Therapeutics has a collaboration and license settlement with Acer Therapeutics for the worldwide improvement and commercialization of Olpruva™ (sodium phenylbutyrate) for the remedy of varied inborn errors of metabolism, together with urea cycle issues (UCDs) and maple syrup urine illness (MSUD). Relief Therapeutics additionally continues to develop aviptadil for a number of uncommon pulmonary indications. Further, Relief Therapeutics is enterprise the scientific improvement of RLF-TD011, a differentiated acid oxidizing resolution of hypochlorous acid supposed for the remedy of epidermolysis bullosa (EB), a bunch of uncommon, genetic, life-threatening connective tissue issues; RLF-TD011 has been granted orphan drug designation by the U.S. FDA. Finally, Relief Therapeutics is commercializing a number of legacy merchandise through licensing and distribution companions.
RELIEF THERAPEUTICS Holding SA is listed on the SIX Swiss Exchange beneath the image RLF and quoted within the U.S. on OTCQB beneath the symbols RLFTF and RLFTY.
For extra data, please go to www.relieftherapeutics.com or comply with Relief Therapeutics on LinkedIn and Twitter.
Disclaimer: This communication expressly or implicitly comprises sure forward-looking statements regarding RELIEF THERAPEUTICS Holding SA. Such statements contain sure recognized and unknown dangers, uncertainties and different elements, together with (i) whether or not the research described above shall be profitable (ii) whether or not APR-TD011 (Nexodyn™ AOS) will ever be authorised within the U.S., the U.Okay., or the E.U. for the remedy of EB or some other illness, and (iii) these dangers mentioned in RELIEF THERAPEUTICS Holding SA's press releases and filings with the SIX and with the U.S. Securities and Exchange Commission, which might trigger the precise outcomes, monetary situation, efficiency or achievements of RELIEF THERAPEUTICS Holding SA to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by such forward-looking statements. RELIEF THERAPEUTICS Holding SA is offering this communication as of this date and doesn't undertake to replace any forward-looking statements contained herein because of new data, future occasions or in any other case.
[1] https://www.aad.org/public/illnesses/skin-cancer/varieties/widespread/ctcl/signs
[2] Cai ZR, Chen ML, Weinstock MA, Kim YH, Novoa RA, Linos E. Incidence Trends of Primary Cutaneous T-Cell Lymphoma within the US From 2000 to 2018: A SEER Population Data Analysis. JAMA Oncol. 2022;8(11):1690–1692. doi:10.1001/jamaoncol.2022.3236
[4] Fortune Business Insights (https://www.globenewswire.com/en/news-release/2022/02/16/2385997/0/en/North-America-Cutaneous-T-Cell-Lymphoma-CTCL-Therapeutics-Market-Size-2022-2028-to-Reach-USD-587-4-Million-at-a-CAGR-13-6.html)
[5] Iacopi E. et al. The Use of a Novel Super-Oxidized Solution on Top of Standard Treatment within the Home Care Management of Postsurgical Lesions of the Diabetic Foot Reduces Reinfections and Shortens Healing Time. Int J Low Extrem Wounds. 2018 Dec; 17(4):268-274
[6] Strohal R, et al. The administration of critically colonized and domestically contaminated leg ulcers with an Acid-Oxidizing Solution: A pilot research. Adv Skin Wound Care 31(4):163-171, 2018.
[7] Ricci E, et al. The administration of power ulcers with an AcidOxidizing Solution. J Wound Care 25(8):443-50, 2016.
File: Ad hoc
End of Inside Information
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