PET probe guided extirpation of FDG-PET positive lymph nodes which are negative on other imaging modalities in head and neck cancer patients scheduled for primary irradiation - PET probe guided extirpation of FDG-PET positive lymph nodes

Start Date09 Sep 9999

Sponsor / Collaborator-

NCT04273555 / RecruitingPhase 1/2IIT

Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)

The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.

Start Date01 Mar 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT06145633 / Not yet recruitingPhase 2IIT

Vorinostat to Augment Response to Lutetium-PSMA-617 in the Treatment of Patients With PSMA-Low Metastatic Castration-Resistant Prostate Cancer

This phase II trial tests how well vorinostat works in treating patients with prostate-specific membrane antigen (PSMA)-low castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) (mCRPC). Prostate cancer that has not spread to other parts of the body (localized) is typically treated through surgery or radiotherapy, which for many men is curable. Despite definitive local therapy, cancer that has come back after a period of improvement (recurrent) disease develops in 27-53% of men. Often this is detected by measurement of prostate-specific antigen (PSA) without visible evidence of metastatic disease. Lutetium Lu 177 vipivotide tetraxetan (177Lu-prostate specific membrane antigen [PSMA]-617) is a new small molecule PSMA-targeted radioactive therapy that has been approved by the Food and Drug Administration for the treatment of adult patients with PSMA-positive mCRPC who have been treated with androgen receptor inhibitors and taxane-based chemotherapy. Vorinostat is used to treat various types of cancer that does not get better, gets worse, or comes back during or after treatment with other drugs. Vorinostat is a drug which inhibits the enzyme histone deacetylase and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat and 177Lu-PSMA-617 may kill more tumor cells in in patients with PSMA-low mCRPC.

Start Date01 Aug 2024

Sponsor / Collaborator

University of Washington

[+2]

100 Clinical Results associated with Fludeoxyglucose F-18

100 Translational Medicine associated with Fludeoxyglucose F-18

100 Patents (Medical) associated with Fludeoxyglucose F-18

473

Literatures (Medical) associated with Fludeoxyglucose F-18

01 Apr 2024·Applied Radiation and Isotopes

Radioprotection in the production of 18F-FDG at Brazilian cyclotron facilities: A comparative study based on dosimetry

Article

Author: Viera, Marcos Aurélio ; Metidieri Cruz Malthez, Anna Luiza

Since the end of the Brazilian state monopoly in 2006, allowing private enterprises to act in producing and commercializing short half-life radiopharmaceuticals, the country observed a growth in the laboratories that use ¹⁸F-FDG to PET/CT exams. Considering the radiological protection and safety techniques applied to radioisotope-producing facilities or units, this study assembled the current situation of radiological protection showing the received doses of the professionals of four facilities with cyclotrons for ¹⁸F-FDG located in south and southeast Brazil in the years 2020 and 2021. The dose values observed are below the dose limits established by national and international regulatory entities but can still be optimized considering differences between the production units.

01 Apr 2024·Molecular Imaging and Biology

Evaluating the Patterns of FAPI Uptake in the Shoulder Joint: a Preliminary Study Comparing with FDG Uptake in Oncological Studies

Article

Author: Buck, Andreas K ; Kosmala, Aleksander ; Higuchi, Takahiro ; Weich, Alexander ; Sasaki, Takanori ; Werner, Rudolf A ; Matsusaka, Yohji ; Serfling, Sebastian E

AbstractBackgroundFibroblast activation protein inhibitor (FAPI) targeting PET has been introduced as a novel molecular imaging modality for visualizing cancer-associated fibroblasts. There have also been reports suggesting incidental findings of localized accumulation in the shoulder joints. However, further characterization in a larger patient cohort is still lacking.Methods77 consecutive patients (28 females; mean age, 63.1 ± 11.6) who underwent Ga-68 FAPI-04 PET/CT for diagnosis of solid tumors were included. The incidence and localization of tracer uptake in shoulder joints were investigated and compared with available F-18 FDG scans serving as reference.ResultsGa-68 FAPI-04 uptake was evaluated in 77 patients (154 shoulder joints), of whom 54 subjects (108 shoulder joints) also had available F-18 FDG scans for head-to-head comparison. On FAPI-targeted imaging, 67/154 shoulders (43.5%) demonstrated increased radiotracer accumulation in target lesions, which were distributed as follows: acromioclavicular (AC) joints in 25/67 (37.3%), followed by glenohumeral and subacromial (GH + SA) joints in 23/67 (34.3%), or both (AC and GH + SA joints) in the remaining 19/67 (28.4%). Ga-68 FAPI-04 correlated with quantified F-18 FDG uptake (r = 0.69, p < 0.0001). Relative to the latter radiotracer, however, in-vivo FAP expression in the shoulders was significantly increased (Ga-68 FAPI-04, 4.7 ± 3.2 vs F-18 FDG, 3.6 ± 1.3, p < 0.001).ConclusionOur study revealed focal accumulation of Ga-68 FAPI-04 in the shoulders, particularly in the AC joints, with higher uptake compared to the inflammatory-directed PET radiotracer F-18 FDG in oncological studies. As a result, further trials are warranted to investigate the potential of FAPI-directed molecular imaging in identifying chronic remodeling in shoulder joints. This could have implications for initiating anti-FAP targeted photodynamic therapy based on PET signal strength.

01 Mar 2024·Current Pharmaceutical Design

Challenging Axillary Lymph Nodes on PET/CT in Cancer Patients Throughout COVID-19 Vaccination Era

Author: Gallicchio, Rosj ; Storto, Rebecca ; Giordano, Alessia ; Di Cosola, Michele ; Storto, Giovanni ; Milella, Mariarita ; Pellegrino, Teresa ; Nappi, Antonio ; Nardelli, Anna

Background:The unexpected detection of axillary lymphadenopathy (AxL) in cancer patients (pts) represents a real concern during the COVID-19 vaccination era. Benign reactions may take place after vaccine inoculation, which can mislead image interpretation in patients undergoing F-18-FDG, F-18-Choline, and Ga-68-DOTATOC PET/CT. They may also mimic loco-regional metastases or disease. We assessed PET/CT findings after COVID-19 first dose vaccination in cancer patients and the impact on their disease course management.Methods:We evaluated 333 patients undergoing PET/CT (257 F-18-FDG, 54 F-18-Choline, and 23 Ga-68 DOTATOC) scans after the first vaccination with mRNA vaccine (Pfizer-BioNTech) (study group; SG). The uptake index (SUVmax) of suspected AxL was defined as significant when the ratio was > 1.5 as compared to the contralateral lymph nodes. Besides, co-registered CT (Co-CT) features of target lymph nodes were evaluated. Nodes with aggregate imaging positivity were further investigated.Results:Overall, the prevalence of apparently positive lymph nodes on PET scans was 17.1% during the vaccination period. 107 pts of the same setting, who had undergone PET/CT before the COVID-19 pandemic, represented the control group (CG). Only 3 patients of CG showed reactive lymph nodes with a prevalence of 2.8% (p < 0.001 as compared to the vaccination period). 84.2% of SG patients exhibited benign characteristics on co-CT images and only 9 pts needed thorough appraisal.Conclusion:The correct interpretation of images is crucial to avoid unnecessary treatments and invasive procedures in vaccinated cancer pts. A detailed anamnestic interview and the analysis of lymph nodes’ CT characteristics, after performing PET/CT, may help to clear any misleading diagnosis.

News (Medical) associated with Fludeoxyglucose F-18

09 Feb 2024

·www.sciencedaily.com

Novel technique has potential to transform breast cancer detection

An innovative breast imaging technique provides high sensitivity for detecting cancer while significantly reducing the likelihood of false positive results. Researchers said the technique has the potential to offer more reliable breast cancer screening for a broader range of patients. An innovative breast imaging technique provides high sensitivity for detecting cancer while significantly reducing the likelihood of false positive results, according to a study published today in Radiology: Imaging Cancer, a journal of the Radiological Society of North America (RSNA). Researchers said the technique has the potential to offer more reliable breast cancer screening for a broader range of patients. Mammography is an effective screening tool for early detection of breast cancer, but its sensitivity is reduced in dense breast tissue. This is due to the masking effect of overlying dense fibroglandular tissue. Since almost half of the screening population has dense breasts, many of these patients require additional breast imaging, often with MRI, after mammography. Low-dose positron emission mammography (PEM) is a novel molecular imaging technique that provides improved diagnostic performance at a radiation dose comparable to that of mammography. For the study, 25 women, median age 52, recently diagnosed with breast cancer, underwent low-dose PEM with the radiotracer fluorine 18-labeled fluorodeoxyglucose (18F-FDG). Two breast radiologists reviewed PEM images taken one and four hours post 18F-FDG injection and correlated the findings with lab results. PEM displayed comparable performance to MRI, identifying 24 of the 25 invasive cancers (96%). Its false positive rate was only 16%, compared with 62% for MRI. Along with its strong sensitivity and low false-positive rate, PEM could potentially decrease downstream healthcare costs as this study shows it may prevent further unnecessary work up compared to MRI. Additionally, the technology is designed to deliver a radiation dose comparable to that of traditional mammography without the need for breast compression, which can often be uncomfortable for patients. "The integration of these features -- high sensitivity, lower false-positive rates, cost-efficiency, acceptable radiation levels without compression, and independence from breast density -- positions this emerging imaging modality as a potential groundbreaking advancement in the early detection of breast cancer," said study lead author Vivianne Freitas, M.D., M.Sc., assistant professor at the University of Toronto. "As such, it holds the promise of transforming breast cancer diagnostics and screening in the near future, complementing or even improving current imaging methods, marking a significant step forward in breast cancer care." Low-dose PEM offers potential clinical uses in both screening and diagnostic settings, according to Dr. Freitas. "For screening, its ability to perform effectively regardless of breast density potentially addresses a significant shortcoming of mammography, particularly in detecting cancers in dense breasts where lesions may be obscured," she said. "It also presents a viable option for patients at high risk who are claustrophobic or have contraindications for MRI." The technology could also play a crucial role in interpreting uncertain mammogram results, evaluating the response to chemotherapy and ascertaining the extent of disease in newly diagnosed breast cancer, including involvement of the other breast. Dr. Freitas, who is also staff radiologist of the Breast Imaging Division of the Toronto Joint Department of Medical Imaging, University Health Network, Sinai Health System and Women's College Hospital, is currently researching PEM's ability to reduce the high rates of false positives typically associated with MRI scans. Should PEM successfully lower these rates, it could significantly lessen the emotional distress and anxiety linked to false positives, Dr. Freitas said. Additionally, it might lead to a decrease in unnecessary biopsies and treatments. More studies are needed to determine low-dose PEM's exact role and efficacy in the clinical setting. "While the full integration of this imaging method into clinical practice is yet to be confirmed, the preliminary findings of this research are promising, particularly in demonstrating the capability of detecting invasive breast cancer with low doses of fluorine-18-labeled FDG," Dr. Freitas said. "This marks a critical first step in its potential future implementation in clinical practice."

Radiation Therapy

14 Nov 2023

·www.globenewswire.com

TransCode Therapeutics Reports Third Quarter 2023 Results; Provides Business Update

BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported financial results for the third quarter ended September 30, 2023, and recent business progress. “In the third quarter of 2023, we successfully completed a follow-on public offering in a very difficult biotech market as we continue our clinical study with our lead therapeutic candidate, an RNA targeted therapeutic candidate for treating metastatic disease,” said Michael Dudley, co-founder, president and Chief Executive Officer of TransCode. “We were excited to dose our first patient in our Phase 0 clinical trial with TTX-MC138 in cancer patients with advanced solid tumors for which further enrollment is underway. TransCode co-founder and Chief Technology Officer, Dr. Zdravka Medarova, commented, “We also announced encouraging preclinical data in glioblastoma multiforme (GBM) with our lead candidate. In addition, we published results of a preclinical study showing that inhibition of microRNA-10b, the therapeutic target of TTX-MC138, in breast cancer cells impaired the capacity of cancer stem cells to create new tumors and become metastatic. We believe these findings are important because cancer stem cells have long been known to play a critical role in cancer initiation, metastasis, recurrence, and resistance to therapy. Therefore, we believe that inhibiting the tumor-creating capacity of these cells using TTX-MC138 has the potential to improve outcomes in patients with breast cancer that is recurrent and resistant to treatment.” Recent Business Highlights In July, the company announced the results of a pre-clinical study of its lead therapeutic candidate, TTX-MC138, in non-human primates, effectively engaging its target and showing favorable pharmacokinetics and tissue distribution. In the study, non-human primates (n = 4) were injected with a microdose of radiolabeled TTX-MC138 and imaged by positron emission tomography-magnetic resonance imaging (PET-MRI) to determine the pharmacokinetics and tissue distribution of the therapeutic candidate. In addition, the pharmacodynamic activity of radiolabeled TTX-MC138 following a microdose injection was determined by measuring inhibition of its target, miRNA-10b, using qRT-PCR. TTX-MC138 demonstrated a long circulation half-life and tissue distribution consistent with hepatic clearance. Importantly, even at a microdose, the therapeutic candidate showed lasting activity and significantly inhibited miRNA-10b, known to be a driver of metastatic progression in a number of cancers.In August, the company dosed the first patient in its First-in-Human Phase 0 clinical study. The Phase 0 trial is an open-label, single-center, microdose study intended to demonstrate delivery of the radiolabeled version of TTX-MC138 to radiographically-confirmed metastases in subjects with advanced solid tumors. Preliminary data showed that radioactivity consistent with accumulation of TTX-MC138 was detected by noninvasive imaging in the regions of the metastatic lesions previously identified by fluorodeoxyglucose (FDG)/positron emission tomography (PET) (FDG/PET). In addition, radiolabeled TTX-MC138 had pharmacokinetic behavior consistent with that expected based on non-clinical IND-enabling studies. The patient tolerated the dosing with no reported adverse reactions. Metabolite analysis indicated circulation of intact radiolabeled TTX-MC138 for more than 20 hours, equivalent to that predicted by Drug Metabolism and Pharmacokinetics (DMPK) modelling, and that the drug candidate analyzed in the blood was identical to that of the manufactured drug candidate, demonstrating in vivo stability. Complete analysis of data from this first patient is in process and will be included in the final report for all patients enrolled in the study.In September, the company announced the results of a pre-clinical study of TTX-MC138 in murine models bearing human glioblastoma multiforme (GBM) tumors. In this study, the therapeutic candidate was delivered to brain tumors where it effectively engaged its target. In the study reported by TransCode, mice implanted with tumors derived from human GBM patients were treated with TTX-MC138 and imaged by magnetic resonance imaging (MRI) to determine delivery of the therapeutic candidate to the tumors. In addition, the pharmacodynamic activity of TTX-MC138 was determined by measuring inhibition of miRNA-10b using qRT-PCR. TTX-MC138 was injected intravenously and accumulated efficiently in the tumors. Importantly, the therapeutic candidate showed lasting activity and significantly inhibited miRNA-10b, known to be a driver of tumor progression in glioblastoma.Also, in September, the company closed an underwritten public offering of an aggregate of 16,863,000 shares of its common stock (or pre-funded warrants in lieu thereof), including the partial exercise of the underwriter’s over-allotment option. Each share of common stock (or pre-funded warrant) was sold at a public offering price of $0.51 per share (inclusive of the pre-funded warrant exercise price of $0.01 per share). All of the shares and pre-funded warrants in the offering were sold by the company. Gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately $8.5 million. Planned Milestones TransCode’s goals to continue to advance its portfolio include: TTX-MC138 Enroll additional patients in First-in-Human Phase 0 clinical trial intended to demonstrate quantifiable evidence of delivery of radiolabeled TTX-MC138 to metastatic lesions in advanced solid tumors; measure pharmacokinetics and biodistribution in vital organs and other tissues; potentially inform therapeutic dose levels for future trials based on Phase 0 microdose results; and potentially validate delivery for the TTX pipeline more broadly, which could open-up additional relevant RNA targets that have been previously undruggable due to challenges with RNA delivery.Submission to FDA of an Investigational New Drug (IND) application for a Phase I clinical trial with TTX-MC138. Publication of preclinical in vivo studies supporting therapeutic candidates, TTX-RIGA and TTX-siPDL1, as well as TTX-MC138 in pancreatic adenocarcinoma.Continuation of discussions with potential strategic partners regarding partnerships in multiple therapeutic areas including CRISPR and intracellular delivery of proteins using TransCode’s TTX delivery platform.Filing for orphan drug designation for TTX-MC138 in additional tumor indications. Third Quarter 2023 Financial Highlights Cash was approximately $7.5 million at September 30, 2023, compared to approximately $5.0 million at December 31, 2022.Research and development expense was approximately $3.3 million in the third quarter of 2023, compared to approximately $3.0 million in the third quarter of 2022.General and administrative expense was approximately $2.0 million in the third quarter of 2023, compared to approximately $1.9 million in the third quarter of 2022.Operating loss for the three months ended September 30, 2023, was approximately $5.3 million, compared to an operating loss of approximately $4.3 million in the prior year period. Financial Guidance TransCode expects that its cash of approximately $7.5 million as of September 30, 2023, is sufficient to fund planned operations into January 2024 but not for a full 12 months from the date of its financial statements. About TransCode Therapeutics TransCode is an RNA oncology company created on the belief that cancer can be more effectively treated using RNA therapeutics. Using its iron oxide nanoparticle delivery platform, the company has created a portfolio of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which is believed to cause approximately 90% of all cancer deaths totaling over nine million per year worldwide. Another of the company’s drug candidates, TTX-siPDL1, focuses on treating tumors by targeting a protein called Programmed death-ligand 1 (PD-L1). TransCode also has three cancer-agnostic programs: TTX-RIGA, an RNA–based agonist of the retinoic acid-inducible gene I designed to drive an immune response in the tumor microenvironment; TTX-CRISPR, a CRISPR/Cas9–based therapy platform for the repair or elimination of cancer-causing genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for the development of cancer vaccines designed to activate cytotoxic immune responses against tumor cells. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning financial position and financial guidance, including cash runway guidance, statements concerning expected clinical results of TransCode’s therapeutic candidates, statements concerning the results of RNA research, statements concerning the potential for treating cancer with RNA therapeutics, statements concerning the timing and outcome of expected regulatory filings and clinical trials, including the Phase 0, First-in-Human study of TTX-MC138, statements regarding planned milestones and goals to continue to advance TransCode’s portfolio, including the timing of regulatory filings and submissions and publications, statements regarding discussions with potential strategic partners and statements concerning TransCode’s development programs and TTX technology platform generally. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with TransCode’s financial condition and its need to obtain additional funding to support its business activities, including TransCode’s ability to continue as a going concern; the risk associated with drug discovery and development; the risk that the results of our planned clinical trials will not be consistent with our pre-clinical studies or expectations; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with TransCode’s planned clinical trials for its product candidates; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with TransCode’s dependence on third parties; and risks associated with global economic and political developments. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode’s actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled “Risk Factors” in TransCode’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release; TransCode undertakes no duty to update this information unless required by law. For more information, please contact: TransCode Therapeutics, Inc.Alan Freidman, VP Investor Relationsalan.freidman@transcodetherapeutics.com

Phase 1VaccineFinancial StatementClinical Result

24 Oct 2023

·www.globenewswire.com

TransCode Therapeutics Announces Preliminary Clinical Results in First Patient in Phase 0 Clinical Study with Lead Therapeutic Candidate, TTX-MC138

Evidence of Drug Accumulation in Metastatic LesionsBOSTON, Oct. 24, 2023 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced preliminary results with its lead therapeutic candidate, TTX-MC138, in the first patient enrolled in its Phase 0 clinical trial aimed at demonstrating delivery of TTX-MC138 to metastatic cancer, including metastases beyond those found in the liver. These preliminary data showed that radioactivity consistent with accumulation of TTX-MC138 was detected by noninvasive imaging in the regions of the metastatic lesions previously identified by fluorodeoxyglucose (FDG)/positron emission tomography (PET) (FDG/PET). In addition, radiolabeled TTX-MC138 had pharmacokinetic behavior consistent with that expected based on non-clinical IND-enabling studies. The patient tolerated the dosing with no reported adverse reactions. Metabolite analysis indicated circulation of intact radiolabeled TTX-MC138 for more than 20 hours, equivalent to that predicted by Drug Metabolism and Pharmacokinetics (DMPK) modelling, and that the drug candidate analyzed in the blood was identical to that of the manufactured drug candidate, demonstrating in vivo stability. Complete analysis of data from this first patient is in process and will be included in the final report for all patients enrolled in the study. TransCode’s Chief Technology Officer, Zdravka Medarova, PhD, commented, “We believe these preliminary clinical data support our thesis that TTX-MC138 can be delivered successfully to metastatic lesions for the potential treatment of metastatic cancer. Preclinical evidence pointing towards miRNA-10b’s critical role in metastatic progression across a number of major cancer types suggests that inhibition of miRNA-10b in patients with advanced disease could have a dramatic impact on their disease.” The Phase 0 trial is an open-label, single-center, microdose study intended to demonstrate delivery of the radiolabeled version of TTX-MC138 to radiographically-confirmed metastases in subjects with advanced solid tumors. Up to 12 subjects may be enrolled in this clinical study, each of which is expected to receive a single microdose of radiolabeled TTX-MC138 followed by positron emission tomography/magnetic resonance imaging (PET-MRI) and blood analyses. The trial is intended to quantify the amount of TTX-MC138 delivered to metastatic lesions, especially beyond the liver, and the pharmacokinetics of the therapeutic candidate in those patients. The trial is intended to yield important data regarding TTX-MC138 delivery to clinical metastases that could inform dose selection and frequency, for further clinical development. The trial is not intended to demonstrate a therapeutic effect. In the earlier IND-enabling studies conducted in non-human primates (NHP), TTX-MC138 demonstrated long circulation and tissue distribution consistent with hepatic clearance. Data from the NHP study were incorporated into a DMPK model, intended to model the pharmacokinetics and tissue distribution of TTX-MC138 in humans. The model predicted circulation and tissue distribution in humans consistent with results from TransCode’s nonclinical studies in which numerous complete regressions of metastatic disease were observed. TTX-MC138 consists of an iron oxide nanocarrier conjugated to a nucleic acid specifically designed to inhibit the oncogenic RNA, microRNA-10b. MiRNA-10b has been described as the master regulator of cancer progression in a number of advanced solid tumors. TransCode believes that TTX-MC138 has the potential to become a treatment for many of these cancers. Administration of TTX-MC138 has demonstrated complete regression of metastatic disease in a number of mouse models of pancreatic and breast cancer. In addition, TTX-MC138 was successfully delivered and demonstrated bioactivity in a case study of spontaneous feline mammary carcinoma. “Our Phase 0 trial involves a single microdose of radiolabeled TTX-MC138 followed by noninvasive PET-MRI imaging and metabolite analysis. Given the similarities between humans and non-human primates relative to anatomy, physiology, and molecular biology, we anticipated results in trial patients comparable to those observed in the DMPK model based on our NHP studies, as evidenced by the preliminary data we announced today,” added Michael Dudley, Chief Executive Officer of TransCode. This study was done in collaboration with Andreas Varkaris, MD, PhD, an attending physician and investigator for the Termeer Center for Targeted Therapies at Massachusetts General Hospital and the principal investigator of TransCode’s study. About TransCode Therapeutics TransCode is an RNA oncology company created on the belief that cancer can be more effectively treated using RNA therapeutics. Using its iron oxide nanoparticle delivery platform, the Company has created a portfolio of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which is believed to cause approximately 90% of all cancer deaths totaling over nine million per year worldwide. The Company believes that TTX-MC138 has the potential to dramatically improve clinical outcomes in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. Another of the Company’s drug candidates, TTX-siPDL1, focuses on treating tumors by targeting a protein called Programmed death-ligand 1 (PD-L1). TransCode also has three cancer-agnostic programs: TTX-RIGA, an RNA–based agonist of the retinoic acid-inducible gene I designed to drive an immune response in the tumor microenvironment; TTX-CRISPR, a CRISPR/Cas9–based therapy platform for the repair or elimination of cancer-causing genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for the development of cancer vaccines designed to activate cytotoxic immune responses against tumor cells. Forward-Looking Statements This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning preliminary first patient results of the Phase 0 clinical trial of radiolabeled TTX-MC138, statements concerning expected clinical results of TransCode’s therapeutic candidates, statements concerning the results of RNA research, statements concerning the potential for treating cancer with RNA therapeutics, statements concerning the timing and outcome of expected regulatory filings and clinical trials, including the current first-in-human study of TTX-MC138, and whether this study will demonstrate proof-of-mechanism, and statements concerning TransCode’s portfolio of drug candidates and TTX technology platform generally. Of note, a Phase 0 clinical trial is an exploratory study, conducted under an exploratory Investigational New Drug (eIND) application. Exploratory IND studies usually involve very limited human exposure to a therapeutic candidate to evaluate mechanism of action in order to inform potential clinical evaluation in future clinical studies, but otherwise have no therapeutic intent. Further, caution should be taken when interpreting the preliminary results of the Phase 0 trial. This data may differ from future results of this study, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Preliminary data also remains subject to audit and verification procedures that may result in the final data being materially different from the preliminary data previously published. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk associated with drug discovery and development; the risk that the results of clinical trials we conduct will not be consistent with our pre-clinical studies or expectations; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with TransCode’s planned clinical trials for its product candidates; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; the risk of competition from other companies developing products for similar uses; risks associated with TransCode’s financial condition and its need to obtain additional funding to support its business activities, including TransCode’s ability to continue as a going concern; risks associated with TransCode’s dependence on third parties; and risks associated with the COVID-19 coronavirus. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode’s actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled “Risk Factors” in TransCode’s Annual Report on Form 10-K for the year ended December 31, 2022, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release; TransCode undertakes no duty to update this information unless required by law. For more information, please contact: TransCode Therapeutics, Inc.Alan Freidman, VP Investor Relationsalan.freidman@transcodetherapeutics.com

Phase 1Clinical ResultVaccinesiRNA

100 Deals associated with Fludeoxyglucose F-18

External Link

KEGG	Wiki	ATC	Drug Bank
-	Fludeoxyglucose F-18	V09IX04	DB09502

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Coronary Artery Disease	US	The Feinstein Institutes for Medical Research	19 Aug 2005
Epilepsy	US	The Feinstein Institutes for Medical Research	19 Aug 2005
Glucose Metabolism Disorders	US	The Feinstein Institutes for Medical Research	19 Aug 2005
Neoplasms	US	The Feinstein Institutes for Medical Research	19 Aug 2005
Ventricular Dysfunction, Left	US	The Feinstein Institutes for Medical Research	19 Aug 2005
Diagnostic agents	-	Bayer AG	01 Jan 1994

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ketosis	Phase 2	US	University of Pennsylvania	05 Jan 2020
Bone metastases	Phase 1	US	National Cancer Institute	01 Apr 2015
Metastatic castration-resistant prostate cancer	Phase 1	US	National Cancer Institute	01 Apr 2015
Prostatic cancer metastatic	Phase 1	US	National Cancer Institute	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAIC2017	Not Applicable	Delirium	28	18F-FLUORODEOXYGLUCOSE-POSITRON EMISSION TOMOGRAPHY (Patients with prolonged delirium)	irurqjyjnf(pgegykurmg) = lnddjaztqr wbnrlgcejn (yghmjhgwtp )	-	01 Jul 2017
				18F-FLUORODEOXYGLUCOSE-POSITRON EMISSION TOMOGRAPHY (Outpatient controls)	irurqjyjnf(pgegykurmg) = lhmqxxbevw wbnrlgcejn (yghmjhgwtp )
ESC2019	Not Applicable	Acute myocardial infarction	36	18F-FDG	(xmkhwyfrcq) = sfmbntnqec gfiepoufae (zhftjyvxom )	-	01 Sep 2019
				18F-FDG	(xmkhwyfrcq) = sbyccchsje gfiepoufae (zhftjyvxom )
EHA2020	Not Applicable	Mantle-Cell Lymphoma	79	18F-FDG PET/CT	iexokhqciv(pdkukpqcsw) = wkjkjxxyav emtpjdyxni (vgeopjuexr ) View more	-	14 May 2020
				18F-FDG PET/CT (Colonoscopy)	uofixfwymd(uhfjyjbqeu) = kazqmmfivk uubqsszwpy (qdcwpvcfdg ) View more
WCLC2015	Not Applicable	Visible Lesion	27	18FDG-PET	(wgxyblzalk) = iveslkshsi gjvrcylhst (nekkytaulv ) View more	-	07 Sep 2015
ASCO2020	Not Applicable	Non-Small Cell Lung Cancer	71	<sup>18</sup>F-FDG (Low colon SUVmax)	(lheneewcun) = hwwlbqkxuc bhyovwqqvw (ejihaurqku ) View more	Positive	25 May 2020
				<sup>18</sup>F-FDG (High colon SUVmax)	(lheneewcun) = hwdelzkhpx bhyovwqqvw (ejihaurqku ) View more
ASCO2020	Not Applicable	Breast Cancer	227	18F-FDG-PET/CT (PET/CT)	ucrpdixlil(purpyhzxjx) = mhcazwcftq ayngmdxfod (bjivdtpjyi ) View more	-	25 May 2020
				18F-FDG-PET/CT (CTBS)	ucrpdixlil(purpyhzxjx) = vypgyionba ayngmdxfod (bjivdtpjyi ) View more
ASCO_GI2017	Not Applicable	squamous cell carcinoma of the anus	87	18FDG-PET (HIV+ patients with N0 lymph nodes)	rarjahgwea(gumvjjlrsm) = qpqurqlwmh puxrmqcygo (dopjrwiaqw ) View more	-	21 Mar 2017
				18FDG-PET (HIV+ patients with N1, N2, or N3 lymph nodes)	rarjahgwea(gumvjjlrsm) = ekmwaphfjv puxrmqcygo (dopjrwiaqw ) View more
ESMO2018	Not Applicable	Occult Macular Dystrophy	93	18F-FDG-PET/CT (PET)	(hhfgiidefy) = jispmrxhkd bfxxajgfux (jsemucaqac, 23 - 32) View more	-	21 Oct 2018
S51.002 (AAN2014)	Not Applicable	18F-FDG PET	14	18F-FDG	gzpmaxslec(neeffhbuwv) = increased continuously in both groups of advanced plaque and early atherosclerosis and was significantly higher in advanced plaques than in early atherosclerosis at 1, 2 and 3 months (P<0.01) syfkwuwwhd (nzehrgiwmx ) View more	-	08 Apr 2014
				18F-FDG
Pubmed	Phase 1	Neoplasms	4	<sup>18</sup>F-FDG	kaadndlllf(tojjojpdcp) = kgwsxzxyhf kzsfogvzxf (irkfynbsts ) View more	-	01 Jan 2020

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