Treatment with leucocytic interferon-alpha more ribavirine towards peg-interferon to reduced doses more ribavirine in patients affections from positive chronic hepatitis HCV that in course of arranged therapy demand the reduction of the peghilato dosage of interferon. - ND

开始日期2005-08-01

申办/合作机构-

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100 项与 DLP-201 相关的转化医学

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4,857

项与 DLP-201 相关的文献（医药）

2025-01-01·BRAIN BEHAVIOR AND IMMUNITY

Acute effects of interferon-alpha on cellular anabolic and catabolic processes are associated with the development of fatigue during Interferon-alpha-based therapy for Hepatitis-C: A preliminary study

Article

作者: Harrison, Neil A. ; Tibble, Jeremy ; Periche-Tomas, Eva ; Pariante, Carmine ; Cattaneo, Annamaria ; Bullmore, Edward T. ; Cattane, Nadia ; Bone, Claudia ; Bullmore, Edward T ; Harrison, Neil A

INTRODUCTION:

Interferon-alpha (IFN-α) is a key mediator of antiviral immune responses used to treat Hepatitis-C virus (HCV) infection. Though clinically effective, IFN-α frequently induces functionally impairing mood and motivation symptoms, particularly fatigue. Unlike mood impairment, which typically emerges after weeks of treatment, fatigue tends to emerge and evolve rapidly, typically within hours of the first IFN-α injection. Despite being a major source of functional impairment during IFN-α and other immune-based therapies, the biological mechanisms underlying fatigue remain poorly understood. Here, we aimed to identify acute immune-response signatures to IFN-α that could predict the later development of fatigue.

METHODS:

In this exploratory study, we analyzed whole blood transcriptomics in a longitudinal sample of 27 HCV patients initiating IFN-α and Ribavirin therapy. Blood samples were obtained at baseline and 4½ hours after the first IFN-α dose and transcriptomic data was obtained using Affymetrix Human Gene 1.1 ST Array Strips. Gene expression data visualization and quality control were assessed using Partek Genomics Suite V6.6 and protein-protein interaction networks using STRING and Ingenuity Pathway Analysis (IPA). A Fatigue Visual Analogue Scale (fVAS) was utilized to record fatigue symptoms at baseline, 4½ hours and 4 weeks after initiation of treatment.

RESULTS:

IFN-α was associated with an upregulation of 526 transcripts and a downregulation of 228 genes, indicating a rapid transcriptomic response in whole blood within 4½ hours of injection. 93 genes were significantly positively correlated with changes in fatigue, with gene expression changes measured from baseline to 4.5 h and increases in fatigue assessed from baseline to week 4 on the fVAS. We identified a novel network of predominantly cytosolic ribosomal units and ubiquitin proteins implicated in modulating mTOR signaling that was associated with the development of fatigue 4 weeks after initiation of IFN-α treatment (p = 0.0078).

CONCLUSION:

Our findings suggest that acute activation of this anabolic/catabolic network by IFN-α may predispose to the experience of fatigue similar to evidence found in cancer-related fatigue. Further investigation is warranted to confirm the exploratory nature of these observations.

2024-09-19·Dentistry Journal

Evaluating Treatment Modalities for Reducing Recurrence in Central Giant Cell Granuloma: A Narrative Review.

Review

作者: Fiorillo, Luca ; Qeli, Etleva Droboniku ; Aliu, Iliriana ; Meto, Aida ; Aliu, Flamur ; Shabani, Donika Bajrami ; Kaçani, Gerta

Treating central giant cell granuloma (CGCG) is challenging due to high recurrence rates and variable therapy responses. This study examines the efficacy of various treatments in reducing CGCG recurrence. A literature review explored outcomes of surgical excision, curettage, intralesional corticosteroid injection, and adjuvant therapy, considering factors like lesion location, size, and histological features. Aggressive surgical techniques such as en bloc resection were found to potentially lower recurrence rates compared to conservative approaches. However, treatment should be tailored to individual patient needs. Further research is needed to confirm these findings and improve treatment strategies. A concise literature review was conducted using PubMed, MEDLINE, and Google Scholar, focusing on papers published from 1986 to 2024. Search terms included "central giant cell granuloma", "recurrence", "treatment modalities", and "surgical excision". Studies reporting recurrence rates and treatment outcomes for CGCG were analyzed. Twenty-nine studies were reviewed, including six studies on surgical excision and curettage, eight studies on intralesional corticosteroid injections, six studies on calcitonin therapy, five studies on interferon-alpha therapy, and four studies on the therapy with denosumab. Analysis indicated that aggressive surgical treatments like en bloc resection were associated with lower recurrence rates compared to conservative methods. Predictors of recurrence included lesion size (>3 cm), location (mandible), and aggressive histopathological features. Aggressive surgical excision combined with nonsurgical methods may lower recurrence rates, while conservative techniques remain viable in some cases. Further prospective research is needed to validate these findings and enhance CGCG treatment options.

2024-09-01·JOURNAL OF INTERFERON AND CYTOKINE RESEARCH

An Anti-CD138-Targeted Interferon-Alpha Has Broad Efficacy in Solid Tumors Through Direct Tumor Cell Killing and Intratumoral Immune Modulation

Article

作者: Stover, David R. ; Morrison, Sherie L. ; Safaie, Tahmineh ; Trinh, Kham R. ; Vasuthasawat, Alex

项与 DLP-201 相关的新闻（医药）

2024-02-05

·BioSpace

Ainos Submits Clinical Hold Complete Response to US FDA to Resolve the Deficiencies on Investigational New Drug Phase II Trial of its VELDONA Formulation Against Mild COVID-19 Symptoms

Updated Chemistry, Manufacturing, and Controls and Stability Test fulfill Ainos' development objectives Resolving the identified deficiencies will accelerate the timeline for Ainos' other clinical trials SAN DIEGO, CA / ACCESSWIRE / February 5, 2024 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it has submitted the clinical hold complete response to the U.S. Food and Drug Administration (the "U.S. FDA") for conducting a Phase II trial of its low-dose oral interferon (IFN)-alpha formulation, VELDONA®, for treatment of mild COVID-19 symptoms. If approved, the Company's Phase II trial is expected to involve a multicenter, parallel, randomized study conducted in Taiwan to evaluate the efficacy of VELDONA® in subjects with mild COVID-19 symptoms during the third quarter of 2024. Mr. Chun-Hsien (Eddy) Tsai, Chairman, President and CEO of Ainos, commented, "Our submission of a clinical hold complete response to the US FDA marks a significant step for Ainos. This key milestone comes on the heels of our successful manufacturing of a GMP Clinical Batch of our VELDONA® investigational new drug. We are confident that our response robustly and comprehensively addresses the issues raised by the FDA, and we anticipate receiving its feedback in due course. Resolving the comments raised by the FDA will expedite our clinical study plan assessing VELDONA®'s effectiveness in individuals exhibiting mild COVID-19 symptoms. We remain committed to advancing and monetizing our product pipeline to create long-term shareholder value." Ainos' recently-commenced VELDONA® manufacturing process fully complies with both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and the U.S. FDA's Current Good Manufacturing Practice regulations. The updated Chemistry, Manufacturing, and Controls ("CMC") information indicates that the stability of VELDONA® can exceed the minimum shelf life of biologicals. Ainos intends to submit a number of additional IND applications during the second half of 2024, including Phase II/III studies for treatment of oral warts in HIV-seropositive patients (designated an orphan drug by the U.S. FDA), and Phase II/III studies for Sjögren's syndrome. Ainos continues to build on its prior studies on influenza and the common cold. Given VELDONA®'s promising results to date, the Company is optimistic that it may become a potential treatment for mild COVID-19 symptoms in the future. Ainos plans to expand its VELDONA® platform for treatment of other viral infections, as a key component of its long-term strategy to enhance and realize the value of this unique compound. Ainos' low-dose oral VELDONA® formulation is designed to enhance a patient's immune response and boost their ability to fight viral infections, while also potentially reducing the side effects and risks caused by high-dose interferons and other small molecule drugs. The Company's previous studies have demonstrated that VELDONA® could inhibit respiratory virus infection, including influenza A. Human studies have shown that IFNα given orally is effective against viral and autoimmune diseases, without the side effects associated with high-dose injections of IFNα. To date, 68 clinical trials have been conducted with low-dose oral IFNα. Nearly 6,000 patients with one of 16 different disease indications and/or healthy volunteers participated in these trials, including a total of 4,600 subjects exposed to IFNα at a dose level ranging from three to 2,000 international units given daily for up to five years. The safety of orally administered IFNα has been consistently demonstrated in these trials. About Ainos, Inc. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing (POCT), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company's products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women's health and certain common STIs. To learn more, visit . Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to date. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of that term in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and are made in reliance upon the "safe harbor" protections provided by such acts for forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements describing the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside the Company's control. The Company's results may differ materially from those indicated in the forward-looking statements. Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the Company's dependence on revenues from the sale of COVID-19 test kits and its VELDONA® Pet product line; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; and the Company's success in managing the growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K, as amended, and its subsequent filings with the SEC. Many of these risks are beyond the Company's control. There may be additional risks that we consider immaterial or that are unknown, and it is not possible to predict or identify all such risks. Ainos cautions that the foregoing list of factors is not exclusive. Ainos also cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law. Investor Relations Contact ICR, LLC Robin Yang Tel: +1 646-224-6971 Email: Ainos.IR@icrinc.com SOURCE: Ainos, Inc. View the original press release on accesswire.com

临床2期孤儿药

2023-09-19

·BioSpace

Assembly Biosciences to Highlight Pipeline Progress in HBV and HDV at the 2023 International HBV Meeting

-- Two oral presentations and one poster will feature new data from the Company’s hepatitis B/hepatitis D entry inhibitor, capsid assembly modulator ABI-4334, and interferon-alpha receptor agonist programs -- SOUTH SAN FRANCISCO, Calif., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced that the company will present new preclinical data from multiple hepatitis B virus (HBV) and hepatitis D virus (HDV) pipeline programs at the 2023 International HBV Meeting taking place in Kobe, Japan, September 19-23, 2023. At the meeting, one oral presentation will highlight progress in the company’s HBV/HDV oral entry inhibitor program including activity, selectivity and pharmacokinetic (PK) data that support advancement towards development candidate nomination. A second oral presentation reports new data for ABI-4334 (4334), Assembly Bio’s most potent capsid assembly modulator (CAM) with a potential best-in-class profile, describing the prevention of HBV DNA integration in vitro. The poster presentation, from the company’s interferon-α receptor (IFNAR) agonist program, characterizes small molecule IFNAR agonists that closely mimic interferon-α’s signaling. “The data we are presenting at the 2023 International HBV Meeting highlight the exciting progress of our preclinical HBV/HDV entry and IFNAR agonist programs, and we anticipate nominating a development candidate from the HBV/HDV entry inhibitor program this year,” said William Delaney, PhD, chief scientific officer of Assembly Bio. “Further, the data reported for 4334 support its potential to prevent HBV DNA integration, a process that has been linked to substantial genetic damage and the development of liver cancer in HBV patients. HBV DNA integration is a pathogenic process that is not directly addressed by nucleos(t)ide analogs and further supports the rationale of targeting the viral core protein through a new class of inhibitors.” HBV/HDV Entry Inhibitor Program HDV is a satellite virus only found in the presence of HBV infection and is considered the most severe form of viral hepatitis. In an oral presentation entitled “Pre-clinical profiling of a novel class of orally bioavailable small molecules potently inhibiting hepatitis B and D virus entry,” the company will present data on a novel class of highly potent, orally bioavailable HBV/HDV entry small molecule inhibitors with favorable drug-like properties. One compound selected for further characterization exhibited potent activity against multiple HBV and HDV genotypes and selective inhibition of sodium taurocholate co-transporting polypeptide (NTCP) compared to other bile acid transporters. This compound further exhibited a favorable PK/pharmacodynamic preclinical pro the potential for once daily dosing. Assembly Bio anticipates nominating a clinical development candidate from the HBV/HDV entry inhibitor program in 2023. Next-Generation HBV CAM Candidate ABI-4334 4334, which has completed Phase 1a evaluation, is a novel, orally bioavailable investigational next-generation CAM that exhibits nanomolar (nM) potency against pgRNA encapsidation and covalently closed circular (ccc)DNA formation in vitro. In patients with chronic HBV infection, HBV DNA integration has been linked to the development of liver cancer. In the oral presentation entitled “ABI-4334, a novel inhibitor of hepatitis B virus core protein, disrupts DL-DNA containing capsids and prevents HBV DNA integration,” data show that in vitro 4334 disrupts RC (relaxed circular)- and DL (duplex linear)-DNA capsid formation at nM levels and inhibits HBV DNA integration in a dose-proportional manner as shown by inverse PCR and next-generation sequencing analyses. Based on the Phase 1a PK data, the target plasma levels of 4334 required for inhibition of HBV DNA integration in these models are achievable. Interferon-α Receptor Agonist Assembly Bio’s IFNAR agonist program seeks to engage IFNα signaling using an orally bioavailable liver-focused small molecule approach to improve tolerability. The poster entitled “Pre-clinical characterization of novel liver-focused small molecules efficiently inhibiting hepatitis B virus by activating type I interferon signaling,” features preclinical data on a novel class of IFNAR agonists that inhibit HBV infection and replication. In vivo analysis of a compound from the series demonstrates that it closely mimics IFNα activity as measured by activating IFN-stimulated response element signaling and inducing the JAK-STAT pathway in the liver and PBMCs. PK data from the same compound exhibit desirable liver exposure and favorable oral bioavailability. Lead optimization of multiple IFNAR agonists is ongoing. Time and location of the presentations are as follows: HBV/HDV Entry Inhibitor: Oral Presentation: Pre-clinical profiling of a novel class of orally bioavailable small molecules potently inhibiting hepatitis B and D virus entry Presenter: Marc P. Windisch, PhD, Assembly Bio Session: Session IV: Drug discovery in preclinical models Date and Time: September 20, 3:30-5:15 PM JST ABI-4334: Oral Presentation: ABI-4334, a novel inhibitor of hepatitis B virus core protein, disrupts DL-DNA containing capsids and prevents HBV DNA integration Presenter: Nuruddin Unchwaniwala, PhD, Assembly Bio Session: Session VIIII: Integration, pathogenesis, and HCC Date and Time: September 22, 11 AM-1 PM JST Interferon-α Receptor Agonist: Poster Presentation: Pre-clinical characterization of novel liver-focused small molecules efficiently inhibiting hepatitis B virus by activating type I interferon signaling Presenter: Marc P. Windisch, PhD, Assembly Bio Session: Session IV: Drug discovery in preclinical models Date and Time: September 20, 5:15-7:15 PM JST Assembly Bio intends to make the presentations available on the “Events & Presentations” page in the “Investors” section of its website at About Assembly Biosciences Assembly Biosciences is a biotechnology company dedicated to the development of innovative small molecule antiviral therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com. Forward-Looking Statements The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to maintain financial resources necessary to continue its clinical studies and fund business operations; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration agreements, in the currently anticipated timeframes; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investor and Corporate: Shannon Ryan SVP, Investor Relations, Corporate Affairs and Alliance Management (415) 738-2992 sryan@assemblybio.com Media: Sam Brown Inc. Hannah Hurdle (805) 338-4752 ASMBMedia@sambrown.com

临床1期临床结果临床2期

2023-07-28

·GlobeNewswire-Health Care

Genenta Announces Ongoing Clinical Trial Progress and Proposed Expansion in Solid Tumor Treatments

Company Selects Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer as Second IndicationCompany Selects Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer as Second Indication MILAN, Italy and NEW YORK, July 28, 2023 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that: the Phase 1 dose-ranging clinical trial in Glioblastoma Multiforme (TEM1-GBM) is progressing in line with the development program. All the patients assigned to Cohort 7 (3x10E/kg Temferon™) are dosed.Enrollment of the patients in Cohort 8 (4x10E/kg) is completed.No dose-limiting toxicity has been observed at this point.The median Overall Survival (OS) is currently equal to 17 months. We have selected Refractory Advanced Genitourinary Malignancies including Renal Cell Cancer (RCC) as the second solid tumor indication for Temferon. Late-stage RCC is considered an orphan disease with an unfavorable prognosis for Stage IV RCC patients. The median OS in high-risk patients is only 6 months with the current standard of care.20% of newly diagnosed patients have metastatic disease.Targeted release of IFN-α (Interferon alpha), which is the anti-tumor payload of our platform, we believe the use of a cell-based delivery mechanism is an innovative and clinically relevant approach to modulating the immune microenvironment in patients with immunogenic malignancies, such as metastatic RCC or Urogenital Cancer (UC).IFN efficacy has been established in UC and immunotherapy is also now well established in this type of cancer, offering the potential opportunity of using Temferon in combination with other I/O products such as checkpoint inhibitors. “We believe the clinical data we are observing in the GBM trial on safety, tolerability, and biological activity allow us to progress the expansion of our platform,” said Pierluigi Paracchi, Chief Executive Officer of Genenta. "The use of Temferon for the treatment of Urogenital Cancer patients is an important step for validating in humans the agnostic nature of our product that has already been demonstrated in several tumor animal models”, continued Pierluigi Paracchi. Temferon is Genenta's product at the most advanced stage of development and consists of the patient's own stem progenitor cells modified with Genenta's platform to express Interferon Alpha (IFN-α) within solid tumors. IFN-α is a well-known immunomodulatory protein that has been used in the clinic for decades for the treatment of a variety of cancers, but with limited current use because of the systemic toxicity. Genenta's platform is designed to avoid systemic toxicity and selectively deliver therapeutic activity within the solid tumor. From pre-clinical experiments, it has been observed that Temferon breaks tumor-induced tolerance, thus allowing the immune system to recognize the tumor and mount a durable immune response. About Genenta and TemferonGenenta (www.genenta.com) is a clinical-stage biotechnology company engaged in the development of a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Temferon™ is based on ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon, which is under investigation in a phase 1/2a clinical trial in newly diagnosed Glioblastoma Multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM), is designed to reach solid tumors, induce a durable immune response not restricted to pre-selected tumor antigens nor type, and avoid systemic toxicity, which are some of the main unresolved challenges in immuno-oncology. Forward-Looking StatementsStatements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion and timing of the phase 1/2a clinical trial or any studies relating to the treatment of glioblastoma multiforme patients who have an unmethylated MGMT gene promoter (uMGMT-GBM). Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta's Annual Report on Form 20-F for the year ended December 31, 2022 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. Genenta MediaTiziana Pollio+39 348 23 15 143tiziana.pollio@genenta.com 1 Tie2 Expressing Monocytes

免疫疗法临床1期孤儿药细胞疗法基因疗法

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