Efficacy and Safety of Thymosin α1 Plus Immune Checkpoint Inhibitors and Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Stage II - IIIB Non Small Cell Lung Cancer: A Prospective, Multicenter, Randomized, Controlled Trial

This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer

Start Date15 Oct 2024

Sponsor / Collaborator

Xuanwu Hospital Capital Medical University

NCT06584006

/ RecruitingPhase 2IIT

A Phase II, Single-Center, Randomized Controlled Clinical Trial Evaluating the Efficacy of Thymalfasin and Recombinant Human Interleukin-2 Injections in Treating Lymphocytopenia in Patients With Malignant Hematological Tumors

To evaluate the efficacy and safety of Thymalfasin for injection in combination with Recombinant Human Interleukin-2 Injections in the treatment of lymphocytopenia in patients with malignant hematological tumors

Start Date01 Sep 2024

Sponsor / Collaborator

The First Affiliated Hospital of Xiamen University

NCT06573398

/ Not yet recruitingPhase 2IIT

Efficacy and Safety of Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for Borderline Resectable Pancreatic Cancer

This is a prospective, single-center, single-arm, phase II clinical study. The primary purpose of the study was to evaluate the efficacy and safety of radiotherapy with sequential albumin-bound paclitaxel + Gemcitabine chemotherapy + anti-PD-1 monoclonal antibody and Thymalfasin for borderline resectable pancreatic cancer, and to explore clinical indicators related to efficacy, further guiding subsequent individualized precise treatment.

Start Date01 Sep 2024

Sponsor / Collaborator

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

100 Clinical Results associated with Thymalfasin

100 Translational Medicine associated with Thymalfasin

100 Patents (Medical) associated with Thymalfasin

1,022

Literatures (Medical) associated with Thymalfasin

01 Jan 2025·Immunity Inflammation and Disease

Clinical Characteristics During and After COVID‐19 Infection Among Healthcare Workers During the First Wave of Omicron in Chongqing, China

Article

Author: Hu, Peng ; Qiu, Yue ; Ren, Hong ; Huang, Tianquan ; Yu, Pingping ; Peng, Mingli ; Tang, Qiao ; Tang, Jing ; Xue, Yunling ; Cai, Nan ; Tang, Haoling ; Chen, Zhiwei

ABSTRACT:

Background:

Revealing the clinical manifestations and associations of COVID‐19 before and after negative transition remains an area of significant uncertainty. The aim of this study is to investigate the clinical characteristics observed during and after Omicron infection among a specific population, namely healthcare workers (HCWs).

Methods:

From November 4, 2022, to January 15, 2023, HCWs in our hospital were enrolled to document clinical symptoms, prevention, and treatment for COVID‐19 using a structured questionnaire.

Results:

A total of 1101 HCWs were included, with SARS‐CoV‐2 infection detected in 78.20% (861/1101) during the observation period. The median duration for nucleic acid conversion was 8 days. Forty‐three symptoms were identified during SARS‐CoV‐2 infection (11 symptoms per individual). The common symptoms were fever, cough, headache, phlegm production, and fatigue (60.67%–83.29%). These symptoms can be further categorized into five groups: fever type, upper respiratory tract type, influenza type, digestive system type, and systemic type—all showing complex and diverse patterns. Following SARS‐CoV‐2 infection, a total of 19 symptoms were recorded including four newly emerged ones: reduced lung capacity, memory loss, lethargy, and inattention. Importantly, we observed a significant association between gastrointestinal symptoms during the nucleic acid positive phase and subsequent neuropsychiatric manifestations after negative conversion. Interestingly, females experiencing menstruation or pregnancy exhibited a higher risk of infection, while inhaled vaccines and thymosin demonstrated a protective effect against SARS‐CoV‐2 infection.

Conclusions:

The clinical manifestations observed in HCWs during and after Omicron infection displayed intricate patterns, shedding new light on the complex interplay between SARS‐CoV‐2 and humans.

01 Nov 2024·Biotechnology & genetic engineering reviews

A Prospective and Randomized Control Study on Effects of Thymalfasin for Injection on Perioperative Immune Function and Long-term Prognosis of Patients with Colorectal Cancer

Article

Author: Wang, Xiaoran ; Li, Zhihan ; Yu, Bin ; Niu, Wenbo ; Hu, Xuhua ; Ding, Yuanyi ; Li, Chenhui ; Li, Zhiying

The objective of this study is to explore the effects of thymalfasin for injection on perioperative immune function and long-term prognosis of patients with colorectal cancer (CRC). In total, 400 patients who entered the groups from February 2019 to January 2021 and underwent radical resection of CRC in the Fourth Hospital of Hebei Medical University were the study subjects. They were separated into experimental group (0-199, XELOX chemotherapy and thymalfasin for injection) and control group (200-400, XELOX chemotherapy) by random number table, and the experimental group was randomly divided into conventional-dose group (n = 100, 1.6 mg of thymalfasin for injection, twice a week) and high-dose group (n = 100, 1.6 mg of thymalfasin for injection, thrice a week) according to a ratio of 1:1, to analyze the effects of different treatment schemes on perioperative immune function and long-term prognosis of CRC patients. Compared with control group, the conventional-dose group and high-dose group had notably lower incidences of perioperative infection (P < 0.05), with no significant difference in both groups (P > 0.05). The experimental group had significantly lower overall incidence of early and late postoperative complications, local recurrence rate and the incidence of distant metastasis, and higher perioperative immune function indexes and median disease free survival (DFS) (P < 0.05). The conventional-dose and high-dose thymalfasin for injection effectively improves the perioperative immune function of CRC patients and reduces the incidence of postoperative complications, as an effective treatment for such patients, which can benefit patients.

01 Oct 2024·Alternative therapies in health and medicine

Mortality Study of Patients with Omicron Infection Before and After the Implementation of the New Crown Standard.

Article

Author: Ma, Xinhua ; Liu, Wei ; Zhang, Lina ; Sun, Yang ; Li, Chunhui ; Lu, Yong ; Wang, Aimin ; Liu, Chun

Objective:

To investigate the mortality rate of patients with Omicron infection before and after the implementation of the new crown standard, and to evaluate the impact of new treatment protocols on the mortality rate of patients with Omicron infection.

Methods:

Clinical data of 1419 Omicron-infected patients treated in our hospital from April 10, 2022 to June 3, 2022 were collected(Patients diagnosed with Omicron infection who met the diagnostic criteria in the "Diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 9)"15 and whose nasal/pharyngeal swab samples were typed as Omicron variants by laboratory viral genotyping). They were divided into the observation group (April 25 2022 - June 3 2022) and the control group (April 10 2022 - April 24 2022) before and after the implementation criteria. Clinical data of 1419 patients were collected and compared between the two groups on whether to use anticoagulant drugs, whether to use antiplatelet drugs, gender, whether to use new drugs of thymosin/thymus method, age, whether to use herbal medicine, whether to use Fuzheng prescription, blood routine, liver function, kidney function indicators, mortality of patients.

Results:

A total of 1419 patients were initially selected; 501 patients with incomplete information were excluded, and finally, 918 patients were included. According to the time period before and after the application criteria, they were divided into an observation group (586 cases) and a control group (332 cases). There were no statistically significant differences in gender, age, antiplatelet drug use, and herbal medicine use between the two groups (P < .05). However, there were significant differences in the use of anticoagulant drugs, thymidine/thymidine drugs, and Fu Zhengfang between the two groups. It was statistically significant that the mortality rate in the observation group (2.39)% was significantly lower than that in the control group (5.12)%. P < .05 White blood cell count, red blood cell ratio, lymphocyte count, hemoglobin, neutrophil count, and neutrophil ratio were not significantly different between the two groups (P < .05) .In comparison to the control group (4.92±8.00)10^9/L, the platelet count in the observation group (4.77±3.41)109/L was considerably lower. The difference was statistically significant (P < .05). The comparison of total bilirubin, total protein values and alkaline phosphatase values between the two groups was not significant (P < .05). In the observation group, albumin (38.71±6.39) g/L, glutamate transaminase (23.93±26.03) U/L, glutathione transaminase (26.12±25.53) U/L, gamma-glutamyltransferase (34.28±52.3) U/L, globulin values (28.13±5.55) g/L were significantly lower than those of the control group (36.66±7.08) g/L, (30.36±65.77) U/L, (33.29±49.72) U/L, (43.76±80.23) U/L, (29.85±5.67) g/L, the difference was statistically significant (P < .05). Between the two groups, there were no significant differences in the values of uric acid or creatinine (P > .05). Levels and uric acid readings did not differ significantly, P > .05. The difference between the urea values of the observation group (7.44±6.34 mmol/L) and the control group (8.75±7.51 mmol/L) was statistically significant (P < .05).

Conclusion:

After the implementation of the treatment protocol for COVID-19 (Trial Version 9), the number of death cases among patients with Omicron variant infection has significantly decreased. The treatment protocol is safe and feasible and can be widely applied in clinical settings..And it will further promote the development and administration of vaccines to prevent and control the spread of the novel coronavirus, reducing the occurrence of patients and death cases.

News (Medical) associated with Thymalfasin

29 Mar 2024

·www.pharmaceutical-technology.com

Gilead’s Vemlidy expands label to treat paediatric chronic HBV

Vemlidy is approved to treat patients six years and older for chronic HBV. Credits: Sundry Photography/Shutterstock.com Soon after GSK gained traction with a US Food and Drug Administration (FDA) fast track designation for its investigational treatment bepirovirsen for chronic hepatitis B virus (HBV), Gilead Sciences has strengthened its position in the indication with an FDA approval for Vemlidy (tenofovir alafenamide) to treat paediatric patients. The once daily 25mg tablets have been greenlit to treat patients with chronic HBV with compensated liver disease that are six years and older and weigh at least 25kg. The supplemental new drug application (sNDA) approval was based on data from the ongoing Phase II Study 1092 (NCT02932150), comparing the safety and efficacy of 25mg Vemlidy to placebo in 88 treatment-naïve and treatment-experienced patients with chronic HBV. As per a 28 March press release, patients treated with Vemlidy and those that switched to open-label Vemlidy after week 24 demonstrated “progressive increases in rates of virological suppression” by week 96. “The expanded indication for Vemlidy for the treatment of children as young as six years old is a testament to the safety, tolerability and efficacy profile of this therapy,” said Dr. Frank Duff, Gilead’s senior vice president of the virology therapeutic area, in the announcement. The pharma giant aims to continue addressing unmet treatment needs for children, he added. Vemlidy, a small molecule nucleoside analogue reverse transcriptase inhibitor, was first FDA approved in 2016 as a treatment for adults with chronic HBV and gained its first label expansion in 2022 to treat patients aged 12 years and older with compensated liver disease. The product is marketed with a boxed warning for post-treatment severe acute exacerbation of hepatitis B. See Also: Angelini gets grant for method for labelling reels using robot and application roller Rohto Pharmaceutical gets grant for ophthalmic composition for treating myopia with crocetin and ginkgo leaf GlobalData’s drugs database forecasts that the hepatitis B treatment market will significantly increase over the next six years to reach $10.5bn in 2029, with analysts predicting a compound annual growth rate of 30%. According to the analysts, 71% of the sales in 2022 were attributed to Vemlidy and SciClone Pharmaceuticals’ Zadaxin, a synthetic polypeptide, indicating market dominance. GlobalData’s consensus forecasts predict that Vemlidy will generate $873m in sales in 2024. GlobalData is the parent company of Pharmaceutical Technology .

Drug ApprovalClinical ResultPhase 2Fast Track

27 Feb 2024

·www.businesswire.com

Sepsis Drug Pipeline Research Report 2024: Insights from 30 Companies and 35 Pipeline Drugs - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Sepsis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Sepsis pipeline landscape is provided which includes the disease overview and Sepsis treatment guidelines. The assessment part of the report embraces, in depth Sepsis commercial assessment and clinical assessment of the pipeline products under development In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Sepsis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D. The therapies under development are focused on novel approaches to treat/improve Sepsis. Sepsis Emerging Drugs Chapters This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Sepsis Emerging Drugs Thymosin alpha 1: SciClone Pharmaceuticals Thymosin alpha 1, referred to as thymalfasin, is a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement. SciClone developed and launched Thymosin alpha 1, under the trade name Zadaxin, for the treatment of hepatitis B virus (HBV) infection and hepatitis C virus (HCV) infections. The drug is also being developed for the treatment of COVID 2019 infections. Scientific and clinical studies have shown that Thymosin alpha 1 helps to stimulate and direct the body's immune response to eradicate infectious diseases, such as HBV, HCV, bacterial, and fungal infections; to fight certain cancers such as melanoma and liver cancer; and to enhance response to vaccines. Clinical trials have shown that Thymosin alpha 1 improves survival in patients in intensive care units being treated for sepsis from severe bacterial infections. The therapy is being evaluated in Phase III stage to treat Sepsis. Currently, the drug is in Phase III stage of its development for the treatment of sepsis. Enibarcimab: AdrenoMed AG Enibarcimab (HAM8101; former name: Adrecizumab) a clinical-stage, first-in-class drug targeting loss of vascular integrity. The strong rationale for Enibarcimab is supported by the elegance of its mode of action, a monoclonal antibody that on binding to its target Adrenomedullin preserves its functionality as regulator of vascular integrity. Enibarcimab targets Adrenomedullin (ADM), a vasoprotective peptide hormone. ADM that remains in the bloodstream, however, has a different effect, one that helps mitigate sepsis: promoting stability of the endothelial barrier by restoring the cell junctions between endothelial cells that ordinarily regulate molecule transport and leakage. In health, levels of ADM in the bloodstream and extravascular space are in equilibrium so that endothelial barrier integrity is maintained and blood pressure remains normal. Currently, the drug is in Phase II stage of its development for the treatment of sepsis. M 6229: Matisse Pharmaceuticals Matisse's platform technology is based on the discovery that in many patients suffering from sepsis, proteins called histones are released by the innate immune system and dying cells into the blood stream, where they are toxic to other cells. Due to a self-enforcing cascade, people may die from organ failure within one or two days. Preclinical results have shown that by neutralizing the toxic histones with Matisse's product M6229, the negative cascade is terminated by neutralization of cationic histones by anionic M6229. Matisse claims to have identified an elegant solution for treating one of the major complications in sepsis by using a non-anticoagulant fraction of heparin called M6229 to neutralize toxic circulatory histones .Currently, the drug is in Phase I stage of its development for the treatment of sepsis. SNIPR 001: SNIPR Biome SNIPR001 is a novel, orally-administered antibiotic that is designed to precisely target difficult-to-treat bacterial infections. It is developed using SNIPR Biome's CRISPR-Guided VectorsT (CGVT Technology), which is designed to deliver CRISPR reagents into target bacterial cells. SNIPR001 is designed to target certain E. coli bacteria in the gut and thus prevent their translocation to the bloodstream, without affecting beneficial bacteria in the microbiome. It contains four CRISPR-armed phages that selectively target and eliminate E. coli strains that are resistant to fluoroquinolone, with demonstrated efficacy in animal disease models. Currently, the drug is in preclinical stage of its development for the treatment of sepsis. Sepsis: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Sepsis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sepsis drugs. Sepsis: Therapeutic Assessment Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Sepsis Report Insights Sepsis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Sepsis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players SciClone Pharmaceuticals AdrenoMed AG Matisse Pharmaceuticals SNIPR Biome Tianjin Chase Sun Pharmaceutical Beijing Scitech-Mq Pharmaceuticals Recce Pharmaceuticals Inotrem Octapharma Shaperon Shionogi Pharmazz Seres Therapeutics Key Products Thymosin alpha 1 Enibarcimab M 6229 SNIPR 001 Kukoamine B ST-1830 RECCE 327 Nangibotide OctaplasLG HY209 Cefiderocol Centhaquine SER 155 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ixi7k5 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Phase 2Phase 3Phase 1

100 Deals associated with Thymalfasin

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KEGG	Wiki	ATC	Drug Bank
D06116	-	A05A	DB04900

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis B, Chronic	CN	Sciclone Pharmaceuticals Italy Srl	01 Jan 1996
Hepatitis B	-	-	-
Hepatitis C	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sepsis	Phase 3	CN	SciClone Pharmaceuticals LLC	06 Sep 2016
Hepatitis C, Chronic	Phase 3	US	SciClone Pharmaceuticals LLC	01 Apr 2002
Hepatitis C, Chronic	Phase 3	PR	SciClone Pharmaceuticals LLC	01 Apr 2002
Advanced Malignant Solid Neoplasm	Phase 2	CN	SciClone Pharmaceuticals LLC	01 Apr 2023
Kidney Failure, Chronic	Phase 2	IT	Alfasigma SpA	01 Nov 2009
Hepatocellular Carcinoma	Phase 2	US	SciClone Pharmaceuticals LLC	28 Apr 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02867267 (TESTS, Pubmed)	Phase 3	Sepsis	1,106	Thymosin α1	ajnbxmxhpx(adfbgtlngn) = aazcrtlfbk nopxumxgyw (lezchlzyuf )	Negative	15 Jan 2025
				Placebo	ajnbxmxhpx(adfbgtlngn) = nmfphhvynz nopxumxgyw (lezchlzyuf )
NCT05790447 (PRaG 5.0 Study, ASTRO2024)	Phase 2	Metastatic Solid Tumor T lymphocyte count	6	PRaG regimen + Thymalfasin	tlbiiikbhn(fzwehqvqge) = viglfdoxgo uhaumqxfmj (ewloqucghj ) View more	Positive	01 Oct 2024
NCT04963712 (Pubmed \| BMC Infect Dis) Manual	Early Phase 1	HIV Infections PD-1 \| TIM-3 \| sjTREC	20	Thymosin α1 1.6 mg	gvigggvtzi(ugpprbttto) = hwgjtomrln frqexyvjga (tohiotfjwh ) View more	Positive	17 Jan 2024
				Thymosin α1ral therapy	gvigggvtzi(ugpprbttto) = wbbwevwgeg frqexyvjga (tohiotfjwh ) View more
GASTO-1043 (Pubmed)	Phase 2	Radiation Pneumonitis \| Locally Advanced Lung Non-Small Cell Carcinoma	69	Thymosin α1 + CCRT	oxkdajbqeg(vxqkagczxa) = tcohhwmkyg gwyjlohvne (erqgltqfvo ) View more	Positive	20 Jul 2022
				CCRT alone	zvzqxryvzm(hafxvmrotq) = hasexstrot yrtmvzkghh (wztkmyisxa ) View more
Pubmed \| Front Immunol	Not Applicable	COVID-19	-	Thymosin Alpha 1	foetozzmni(umceynktma) = yuddbqdzkc xvzfendvsb (cxikuqyzkg )	-	02 Aug 2021
				Non-Thymosin Alpha 1	foetozzmni(umceynktma) = hbpwjcghgf xvzfendvsb (cxikuqyzkg )
ICML2017	Not Applicable	Diffuse Large B-Cell Lymphoma	-	R-CHOP plus thymosin α1	fiqfdzkyhc(xyqdgdjetv) = lwvmtqrjbv erktgctaab (udrxhfibri ) View more	Positive	07 Jun 2017
				R-CHOP	fiqfdzkyhc(xyqdgdjetv) = aejdmgaxnv erktgctaab (udrxhfibri ) View more
NCT01178996 (Pubmed \| J Viral Hepat)	Phase 3	Hepatitis C, Chronic Adjuvant	552	Thymosin alpha-1 + Peginterferon alfa-2a/Ribavirin	orolbqvnlm(lmpdukdozq) = tdhaztlpuf axpbwemmzl (jbscpywyzg )	-	01 Jan 2012
				Placebo + Peginterferon alfa-2a/Ribavirin	orolbqvnlm(lmpdukdozq) = nbkyblpndu axpbwemmzl (jbscpywyzg )
NCT00911443 (CTgov)	Phase 2	Malignant melanoma, metastatic	488	Interferon Alpha+Thymosin-alpha-1+Dacarbazin (Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg)	wbjmprqamf(bebljpaubj) = qdotmqrmgi thxhjocvmn (cgldkndybi, wrlvwyugbq - ahcyaikexw) View more	-	02 Jun 2009
				Thymosin-alpha-1+Dacarbazin (Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg)	wbjmprqamf(bebljpaubj) = mzhxponzya thxhjocvmn (cgldkndybi, jfkjbtwqsl - iwdffkuphy) View more
ASCO2005	Not Applicable	Advanced breast cancer	18	thymalfasin (Group 1)	swuvtbzxjr(qrsyrqusja) = rauhtadbot jtnvhskbew (lobhccogdh )	-	01 Jun 2005
				thymalfasin (Group 2)	ejcxqjtsbj(kjyxkppeme) = vexoxdijox rbdqumpouz (whruuvjkkp )

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