This phase III trial compares the effect of adding pirtobrutinib to the usual treatment with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) to R-CHOP alone for the treatment of Richter transformation, which is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into large B-cell lymphoma, a more aggressive (faster-growing) form of lymphoma. Pirtobrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Adding pirtobrutinib to R-CHOP may kill more cancer cells than R-CHOP alone in patients with Richter transformation.

Start Date02 May 2026

Sponsor / Collaborator

SWOG

[+1]

NCT07224100

/ Not yet recruitingPhase 2IIT

Phase II Study of Dose-Adjusted EPOCH ± Rituximab + Ponatinib for Adults With Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma

This phase II trial tests the effect of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) with or without rituximab plus ponatinib in treating patients newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is a drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. DA-EPOCH involves a longer exposure time to doxorubicin, vincristine and etoposide compared to a higher concentration over a shorter time which may provide better tumor response. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Ponatinib blocks BCR::ABL1 and other proteins, which may help keep cancer cells from growing and may kill them. It may also prevent the growth of new blood vessels that tumors need to grow. Ponatinib is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving DA-EPOCH with or without rituximab plus ponatinib may be safe, tolerable, and/or effective in treating patients with newly diagnosed Ph+ ALL.

Start Date01 May 2026

Sponsor / Collaborator

University of Washington

[+1]

NCT07227584

/ Not yet recruitingPhase 2IIT

Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)

The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).
The names of the study drugs involved in this study are:
* blinatumomab (a type of immunotherapy drug)
* cyclophosphamide (a type of chemotherapy drug)
* cytarabine (a type of antineoplastic agent)
* dexamethasone (a type of synthetic glucocorticoid)
* doxorubicin (a type of antineoplastic agent)
* etoposide (a type of antineoplastic agent)
* mercaptopurine (a type of antineoplastic agent)
* methotrexate (a type of chemotherapy drug)
* pegaspargase (a type of antineoplastic agent)
* vincristine (a type of antineoplastic agent)

Start Date01 Apr 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

100 Clinical Results associated with Vincristine Sulfate

100 Translational Medicine associated with Vincristine Sulfate

100 Patents (Medical) associated with Vincristine Sulfate

14,952

Literatures (Medical) associated with Vincristine Sulfate

31 Dec 2025·Hematology

Dose adjusted EPOCH-R is superior to RCHOP in frontline treatment of mediastinal large B cell lymphoma

Article

Author: Shahin, Omar ; Al-Rwashdeh, Mohammad ; Abufara, Alaa ; Muqbel, Ro’a ; Halahleh, Khalid ; Al-rabi, Kamal ; Al-Ibraheem, Akram ; Abed, Nebras Abu ; Farfoura, Heba ; Abdel-Razeq, Hikmat ; Ma'koseh, Mohammad ; Yaseen, Abeer ; Rahman, Zaid Abdel

INTRODUCTION:

Primary Mediastinal Large B Cell Lymphoma (PMLBCL) is a rare but aggressive B-cell lymphoma. This study compares the outcomes and toxicities of DA-EPOCH-R (Dose-adjusted etoposide, prednisolone, vincristine, cyclophosphamide, and doxorubicin in combination with rituximab) and RCHOP-21 (rituximab, cyclophosphamide, doxorubicin, and vincristine, every 21 days) in the treatment of newly diagnosed PMLBCL.

METHODS:

We retrospectively reviewed the medical records of adults (>18 years) diagnosed with PMLBCL and treated at our center from 2010 to 2023. Baseline characteristics were compared using chi-square and Mann Whitney U-tests. Survival outcomes were analysed using Kaplan Meier and log-rank tests.

RESULTS:

Eighty-seven patients were included, with a median age of 30 years (range: 18-55), 48 patients (55.2%) received RCHOP-21, and 39 patients (44.8%) received DA-EPOCH-R. Radiotherapy was more frequent in the RCHOP-21 group (66.6% vs 15%, p < 0.001). DA-EPOCH-R achieved a higher complete metabolic response (CMR) (92% vs 69%, p = 0.007). After a median follow-up of 47.4 months, patients treated with DA-EPOCH-R had superior overall survival (OS) and progression free survival (PFS); 3-year OS rates were 94.4% vs 69.8% (p = 0.01) and the 3-year PFS rates were 86.7% vs 62.2% (p = 0.016), particularly in patients with aa-IPI >1. Post-chemotherapy delta SUV max <0.75, and <0.7 correlated with relapse and mortality, respectively. Grade III-IV anemia and non-hematological toxicities were more frequent in the DA-EPOCH-R, but no therapy-related deaths occurred.

CONCLUSIONS:

DA-EPOCH-R improves CMR, PFS, and OS compared to R-CHOP-21 with radiotherapy in PMLBCL, particularly in high-risk patients. Longer follow-up is needed to assess long-term toxicities.

01 Dec 2025·Blood Research

Real-world data analysis of survival outcomes of patients with primary mediastinal large B-cell lymphoma treated with immunochemotherapy: the role of consolidative radiation therapy

Article

Author: Yoon, Sang Eun ; Oh, Dongryul ; Lee, Yong-Pyo ; Ko, Young Hyeh ; Kim, Seok Jin ; Kim, Won Seog ; Cho, Junhun

Abstract:

Purpose:

Primary mediastinal large B-cell lymphoma (PMBCL) is a rare subtype of diffuse large B-cell lymphoma. Radiation therapy (RT) has served as the primary treatment option for PMBCL; however, its role has been questioned with the advent of intensified immunochemotherapy. This study aimed to investigate the role of consolidative RT in the primary treatment of PMBCL.

Methods:

This single-center retrospective study analyzed the survival outcomes of 65 patients newly diagnosed with PMBCL. The patients were divided into three treatment groups: (1) EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab), (2) R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), and (3) R-CHOP with consolidative RT.

Results:

The objective response and complete remission rates were 86.2% and 63.1%, respectively, with 3-year progression-free survival (PFS) and overall survival (OS) rates of 72% and 81%, respectively. All patients in the R-CHOP + RT group achieved an objective response with better PFS) than those who did not receive consolidative RT (p = 0.028), although there was no significant difference in OS (p = 0.102). Consolidative RT benefited patients with an initially bulky disease or insufficient end-of-treatment response. The predictive value of 18F-fluorodeoxyglucose positron-emission tomography-computed tomography (PET-CT) in assessing the treatment response in PMBCL was revalidated, showing that patients who achieved negative end-of-treatment PET-CT had significantly better survival outcomes than others.

Conclusions:

R-CHOP is a useful alternative regimen when intensified chemotherapy is not feasible. Consolidative RT should be considered in cases with an initially bulky disease and insufficient end-of-treatment response.

01 Dec 2025·ARCHIVES OF BIOCHEMISTRY AND BIOPHYSICS

Lauryl gallate induces apoptosis via p38-MAPK phosphorylation and autophagy in chemoresistant human lung cancer cells

Article

Author: Huang, Yen-Hsiang ; Chiu, Ling-Yen ; Lee, Po-Hsin ; Hsu, Kuo-Hsuan ; Cherng, Shur-Hueih ; Yang, Tsung-Ying ; Sheu, Gwo-Tarng ; Tseng, Jeng-Sen

Human lung cancer has taken many lives and chemoresistance generally occurs in patients and reduces patients' survival. Docetaxel (DOC) and vincristine (VCR) have been widely used in cancer chemotherapy but their efficacy is restricted by P-glycoprotein (P-gp) overexpression. Lauryl gallate (LG) is a plant-derived small molecule which acts as antioxidant in normal cells. Surprisingly, LG also has been shown to control several types of cancer cells and induce apoptosis by way of induction of reactive oxygen species (ROS). To further clarify the anti-lung cancer activity of LG, we evaluated the cytotoxicity of LG using a previously established human A549/DOC resistant subline that has high P-gp expression and a A549/VCR resistant subline to determine their LG sensitivity by MTT assay. The apoptosis and autophagy levels were examined by protein analysis and flow cytometry. Interference of p38-MAPK and ATG5 expression by siRNAs was performed to measure the involvement of these two proteins in apoptosis and autophagy. We found that LG exerts higher cytotoxicity to the target cells when compared with tannic acid (TA) and octyl gallate (OG). Furthermore, LG not only induces apoptosis, it also enhances autophagy in both chemoresistant A549 sublines. When p38-MAPK was knocked down, the apoptosis level was reduced but autophagy was not. Knockdown of ATG5 resulted in significant apoptosis reduction in VCR-resistant A549 cells but less effect was found in DOC-resistant A549 cells. In sum, our data suggested that LG promotes p38-MAPK phosphorylation and induces apoptosis in chemoresistant A549 cells independently with P-gp expression. LG also enhances autophagy-regulated cell death in chemoresistant lung cancer cells.

117

News (Medical) associated with Vincristine Sulfate

11 Jun 2025

·jaguarhealth.gcs-web.com

First Study Site Established for Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs

Two parallel goals for Canalevia-CA1 (crofelemer delayed-release tablets): To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) and to expand the indication of crofelemer from CID to treatment of general, non-infectious diarrhea in dogs Jaguar in discussions with potential partners to license and fund development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S. and/or globally Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved drugs to treat general diarrhea in dogs SAN FRANCISCO, CA / ACCESS Newswire / June 11, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), under its Jaguar Animal Health tradename for the veterinary market, today announced that the first study site has been established for Jaguar's field study of Canalevia-CA1, Jaguar's U.S. Food and Drug Administration (FDA) conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Jaguar has two parallel goals for Canalevia-CA1 (crofelemer delayed-release tablets): To obtain full approval of the drug for treatment of chemotherapy-induced diarrhea (CID) in dogs and to expand the indication of crofelemer from CID in dogs to treatment of general, non-infectious diarrhea in dogs. The company is in discussions with potential partners to fund development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S. and/or globally. "We've been pleased with the marketplace reception of crofelemer for treatment of CID in dogs, and believe there is clearly an unmet medical need for a product for the much larger market of treatment of general, non-infectious diarrhea in dogs," said Lisa Conte , Jaguar's Founder and CEO. "We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to identifying a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in the U.S and/or globally. Forging a partnership for this purpose is a key focus of our business development efforts in 2025 and has been designated as a key potential catalyst for the company this year." "Jaguar's canine-focused business development efforts align with our ongoing business development efforts on the ‘human' side of the company for crofelemer - the catalysts for which are the pathways discussed with the FDA to bring crofelemer to metastatic breast cancer patients, a population we feel meets the requirements for orphan drug status; and the prompt establishment of an expanded access program for crofelemer for the ongoing important unmet medical need of cancer therapy-related diarrhea in breast cancer patients; and the initial proof-of-concept results from the ongoing investigator-initiated trial (IIT) of a novel liquid formulation of crofelemer in Abu Dhabi in pediatric patients with intestinal failure due to the orphan diseases microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF). As recently announced, the initial proof-of-concept results of this IIT show crofelemer reduced the required total parenteral nutrition (TPN) and/or supplementary intravenous fluids, collectively referred to as parenteral support, in patients with intestinal failure due to MVID and short bowel syndrome by up to 27% and 12.5% respectively." The objective of the prospective, randomized, open-label field study in dogs undergoing chemotherapy treatment across the U.S. is to collect real-world data to demonstrate real-world evidence of the clinical effectiveness for Canalevia-CA1 for the treatment of CID in dogs to support potential full FDA approval of the drug for this indication. Dogs enrolled in this study will be randomly assigned to receive a prescription of Canalevia-CA1 as a treatment for CID or be randomly selected to the control group. As announced, Jaguar established a new Investigational New Animal Drug (INAD) file with the FDA's Center for Veterinary Medicine for crofelemer to treat general, non-infectious diarrhea in dogs. Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved drug to treat canine general, non-infectious diarrhea. According to the American Veterinary Medical Association , there were an estimated 89.7 million dogs in the United States in 2024, with nearly half (45.5%) of U.S. households owning a dog in 2024. Devastating diarrhea-related dehydration can occur rapidly for the animal, and the lack of control in urban settings where owners don't have easy access to outdoor facilities is a significant problem for families with dogs. Canalevia-CA1, a canine-specific formulation of crofelemer, Jaguar's novel, oral plant-based drug sustainably harvested from the Croton lechleri tree, is available from multiple leading veterinary distributors in the U.S. , including Chewy. About Conditional Approval and Full Approval Canalevia-CA1 initially received conditional approval in December 2021 from the FDA for the treatment of CID in dogs. FDA's conditional approval allows a drug company to legally promote, advertise and sell the animal drug for the labeled uses before proving it meets the "substantial evidence" standard of effectiveness for full approval. The conditional approval is valid for one year. The drug company can ask the FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval. To receive a renewal from the FDA, the company must show active progress toward proving "substantial evidence of effectiveness" for full approval. After collecting the remaining effectiveness data, the company then applies to the FDA for full approval. The FDA reviews the application and, if appropriate, fully approves the drug. About Chemotherapy-induced Diarrhea (CID) in Dogs According to the American Veterinary Medical Association , approximately 1 in 4 dogs will, at some stage in their life, develop cancer, and almost 50% of dogs over age 10 will develop cancer.1 According to the National Cancer Institute , which is part of the National Institutes of Health , roughly 6 million new cancer diagnoses are made in dogs each year in the U.S. Due to the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and primary care veterinarians, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,2 and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the U.S. veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID. Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID in dogs. About Canalevia®-CA1 Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is currently conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval. Jaguar has also received Minor Use in a Major Species (MUMS) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use. About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals , a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. Important Safety Information About Canalevia®-CA1 For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that it will identify a partner to fund and execute development and commercialization of crofelemer for the treatment of general, non-infectious diarrhea in dogs in the U.S and/or globally, Jaguar's expectation that the U.S. population of metastatic breast cancer patients meets the requirements for orphan drug status, Jaguar's expectation that it will promptly establish an expanded access program for crofelemer for cancer therapy-related diarrhea in breast cancer patients, and Jaguar's expectation that the field study of Canalevia-CA1 for the treatment of CID in dogs will support potential full FDA approval of the drug for this indication. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 "Cancer in Pets." American Veterinary Medical Association , 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets 2 Mason SL, Grant IA , Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398 Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.

Drug ApprovalClinical ResultOrphan Drug

17 Apr 2025

·www.globenewswire.com

Moleculin Announces Acceptance of Abstract to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2025

HOUSTON, April 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced that an abstract regarding the Company’s next-generation anthracycline, Annamycin, has been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025, at the McCormick Place Convention Center in Chicago, IL. Details of the presentation are as follows: Title: Combining Annamycin, a Non-cardiotoxic Potent Topo II Poison, with Azacitidine, Cytarabine, Gemcitabine, Ifosfamide, Trabectedin, or Vincristine to Synergize Anticancer Effects and Identify Potential Clinical ApplicationsTrack: Experimental and Molecular TherapeuticsSession: PO.ET02.03. Drug Combination Strategies for Cancer TreatmentAbstract Number: 1683/ 14Presenter: Rafal Zielinski, Ph.D., Department of Experimental Therapeutics, Division of Cancer Medicine, MD Anderson Cancer CenterDate and Time: April 28, 2025, 9:00 AM – 12:00 PM ETLocation: Section 19For more information and to view the abstract, visit the AACR Annual Meeting website. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook. Forward-Looking StatementsSome of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the achievements of each of the milestones in this press release. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the milestones described in this press release assume the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com

Phase 3AACR

28 Mar 2025

·jaguarhealth.gcs-web.com

83.33% of Veterinary Oncologists Highlight Importance of Jaguar Health's FDA Conditionally Approved Canalevia-CA1 as a Non-Antibiotic Treatment for Chemotherapy-Induced Diarrhea (CID) in Dog's in New Survey

Canalevia®-CA1 (crofelemer delayed-release tablets) is the first and only treatment for CID in dogs to receive any type of approval from the FDA In dogs undergoing chemotherapy, as is the case with people undergoing cancer treatment, diarrhea is a highly neglected and unmet medical need SAN FRANCISCO, CA / ACCESS Newswire / March 28, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced the results of a new survey of 27 board certified veterinary oncologists practicing in the U.S. regarding Canalevia-CA1 and the treatment of chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1, the company's U.S. Food and Drug Administration (FDA) conditionally approved prescription drug product for the treatment of CID in dogs, is available from multiple leading veterinary distributors in the U.S. , including Chewy. Of the veterinary oncologists who participated in the survey, 20 (83.33%) indicated that, due to concerns about antibiotic resistance, they felt it was somewhat important to extremely important that Canalevia-CA1 is not an antimicrobial. "Chemotherapy-induced diarrhea can be challenging to control. Canalevia-CA1 has allowed me to continue anti-cancer therapy in patients in an advanced state of disease while thoroughly managing any GI upset they may experience," said Christine Swanson , DVM, DACVIM (Oncology), a Veterinary Oncologist and Medical Director with BluePearl Specialty + Emergency Pet Hospital . "As a veterinary oncologist, I recognize the critical role that supportive therapies play in treating cancer in dogs," said Craig Clifford DVM, MS, CACVIM (Oncology). "One challenging side effect is chemotherapy-induced diarrhea, which can significantly impact a dog's quality of life and hinder their ability to tolerate further treatment. Needless to say, the impact also extends to the patient's family in dealing with the aftermath. The novel natural product Canalevia CA-1 significantly advances our approach to managing chemotherapy-induced diarrhea in canine patients. This innovative therapy not only helps to alleviate diarrhea symptoms but may enhance cancer treatment's overall efficacy by allowing dogs to maintain their chemotherapy schedule. By providing a targeted solution that improves gastrointestinal health, this product offers an alternative to metronidazole in this era of microbial stewardship." "In dogs undergoing chemotherapy, as is the case with people undergoing cancer treatment, diarrhea is a highly neglected and unmet medical need," said Ian Wendt , Jaguar's Chief Commercial Officer. "Jaguar is deeply committed to supporting the quality of life of people and animals undergoing cancer treatment, and Canalevia-CA1 is an important prescription drug for the veterinary community and the thousands of dogs experiencing CID." Other key highlights of the survey of veterinary oncologists include: Of the 24 participants who responded to the question "When managing CID in dogs, which statement best describes your view of metronidazole as a treatment option?", 15 (62.5%) indicated that they are concerned with antimicrobial resistance when treating dogs for CID, and prefer not to use metronidazole for the treatment of CID in dogs. Of the 24 participants who responded to the question "When a dog experiences CID, how big of a negative impact does this have on the dog's ability to stay on their index cancer treatment, their quality of life, and the impact on the dog owner?", 16 (66.66%) indicated that they rate CID as having a moderate to large negative impact on a dog's ability to stay on their index cancer treatment, on a dog's quality of life, and on the dog's owner. Of the 24 participants who responded to the question "When managing CID in dogs, which statement best describes your view of metronidazole as a treatment option?", 15 (62.5%) indicated that they are concerned with antimicrobial resistance when treating dogs for CID, and prefer not to use metronidazole for the treatment of CID in dogs. Of the 24 participants who responded to the question "When a dog experiences CID, how big of a negative impact does this have on the dog's ability to stay on their index cancer treatment, their quality of life, and the impact on the dog owner?", 16 (66.66%) indicated that they rate CID as having a moderate to large negative impact on a dog's ability to stay on their index cancer treatment, on a dog's quality of life, and on the dog's owner. While metronidazole, the current standard of care therapy for treatment of CID in dogs, is commonly prescribed for dogs to treat infections and inflammatory conditions that cause diarrhea, these are off-label uses of the medication, as metronidazole is not FDA approved for dogs. Canalevia-CA1 is the first and only treatment for CID in dogs to receive any type of approval from the FDA. As announced, Jaguar is seeking a partner to fund and execute the development and commercialization of crofelemer, to expand the indication for the treatment of general, non-infectious diarrhea in dogs. The targeted partner would have greater capability to market and promote to the proposed expanded indication of Canalevia in the US. "We've been pleased with the marketplace reception of crofelemer for treatment of CID in dogs and gratified that both dogs and their families are able to find relief and improved quality of life. We believe there is clearly an unmet need for this plant-based product to treat general, non-infectious diarrhea in dogs as well," Conte said. "We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs." About Chemotherapy-induced Diarrhea (CID) in Dogs According to the American Veterinary Medical Association , approximately 1 in 4 dogs will, at some stage in their life, develop cancer, and almost 50% of dogs over age 10 will develop cancer.1 According to the National Cancer Institute , which is part of the National Institutes of Health , roughly 6 million new cancer diagnoses are made in dogs each year in the U.S. Due to the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and primary care veterinarians, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,2 and managing side-effects such as diarrhea can be important to maintain successful cancer treatment. More than half of the U.S. veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID. Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID in dogs. About Canalevia®-CA1 Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only oral plant-based prescription product that is FDA conditionally approved to treat chemotherapy-induced diarrhea (CID) in dogs. Canalevia-CA1 is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is currently conditionally approved by the FDA under application number 141-552. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval. Jaguar has also received Minor Use in a Major Species (MUMS) designation from the FDA for Canalevia-CA1 to treat CID in dogs. FDA has established a "small number" threshold for minor use in each of the seven major species covered by the MUMS act. The small number threshold is currently 80,000 for dogs, representing the largest number of dogs that can be affected by a disease or condition over the course of a year and still have the use qualify as a minor use. About Crofelemer Crofelemer is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals , a Jaguar family company, has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for Indigenous communities. Important Safety Information About Canalevia®-CA1 For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 "Cancer in Pets." American Veterinary Medical Association , 2021, https://www.avma.org/resources/pet-owners/petcare/cancer-pets 2 Mason SL, Grant IA , Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after vincristine or cyclophosphamide administered with or without maropitant in dogs: a prospective randomised controlled study. J Small Anim Pract. 2014;55:391-398 Contact: hello@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc.

Drug ApprovalClinical Result

100 Deals associated with Vincristine Sulfate

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KEGG	Wiki	ATC	Drug Bank
D02197	Vincristine Sulfate	L01CA02	DB00541

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pheochromocytoma	Japan	Nippon Kayaku Co., Ltd.	26 Mar 2013
Extensive stage Small Cell Lung Cancer	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Female Genital Neoplasms	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Mycosis Fungoides	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Osteosarcoma	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Rhabdomyosarcoma	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Uterine Cervical Cancer	Brazil	Libbs Farmacêutica Ltda.	20 Nov 2006
Astrocytoma	Japan	Nippon Kayaku Co., Ltd.	14 Feb 2005
Glioma	Japan	Nippon Kayaku Co., Ltd.	14 Feb 2005
Ewing Sarcoma	China	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Leukemia	China	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Leukemia	China	Yangzhou Pharmaceutical Co., Ltd.	01 Jan 1982
Melanoma	China	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Neuroblastoma	China	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Neuroblastoma	China	Yangzhou Pharmaceutical Co., Ltd.	01 Jan 1982
Small Cell Lung Cancer	China	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Wilms Tumor	China	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
acute leukemia	Japan	Eli Lilly Japan KK	18 Apr 1968
Chronic leukemia	Japan	Eli Lilly Japan KK	18 Apr 1968
Acute Lymphoblastic Leukemia	United States	Eli Lilly & Co.	10 Jul 1963

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adult Lymphoblastic Lymphoma	Phase 2	United States	Pfizer Inc.	23 Jan 2025
Adult Lymphoblastic Lymphoma	Phase 2	United States	Amgen, Inc.	23 Jan 2025
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	Phase 2	United States	Amgen, Inc.	23 Jan 2025
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	Phase 2	United States	Pfizer Inc.	23 Jan 2025
Classical Hodgkin's Lymphoma	Phase 2	United States	Teva Pharmaceuticals USA, Inc.	12 Dec 2018
Classical Hodgkin's Lymphoma	Phase 2	United States	Seagen, Inc.	12 Dec 2018
Ph-Like Acute Lymphoblastic Leukemia	Phase 2	United States	Spectrum Pharmaceuticals, Inc.	05 Mar 2013
Bone Cancer	Phase 2	United States	Amgen, Inc.	01 May 2011
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 2	France	Zeneus Pharma Ltd.	01 Oct 2002
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 2	Germany	Zeneus Pharma Ltd.	01 Oct 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01777152 (ECHELON-2, Pubmed \| Blood Adv)	Phase 3	Peripheral T-Cell Lymphoma	452	BV-CHP	ilmewydqzm(lpceilbogv): HR = 0.38 (95.0% CI, 0.16 - 0.94) View more	Positive	09 Dec 2025
				CHOP
NCT00136435 (CTgov)	Phase 2	Acute Lymphoblastic Leukemia	100	L-asparaginase	aeatvyuwpw = kfvfpjcdre pjuanxkdgf (masawotjfr, xgkawddzwk - tqiagkbrma) View more	-	20 Oct 2025
ESMO2025	Not Applicable	Enteropathy-Associated T-Cell Lymphoma	56	mNewcastle regimen	hkqjvbkgqn(vnwdfrnzkx) = wkqvcilzwp ditfdrkhtn (wicqhqewgl ) View more	Positive	17 Oct 2025
				CHOP-like regimens	hkqjvbkgqn(vnwdfrnzkx) = jpjzeswpea ditfdrkhtn (wicqhqewgl ) View more
NCT00278408 (UNFOLDER, CTgov)	Phase 3	CD20 positive B-Cell Lymphoma	700	R-CHOP-21 (Interventional: 6 R-CHOP-21 for Patients With Radiotherapy Indication)	kjhoambtwd = kzuocnavko qsqpayjmzd (qyhceumwyt, bafhuvjenj - fnktuyqlmc) View more	-	26 Aug 2025
				R-CHOP-14 (Interventional: 6 R-CHOP-14 for Patients With Radiotherapy Indication)	kjhoambtwd = ruhpmbtvti qsqpayjmzd (qyhceumwyt, ixlrdqbhfg - dqehgvngdn) View more
NCT00878254 (CTgov)	Phase 2	Mantle-Cell Lymphoma	25	Mesna+Etoposide+Cyclophosphamide+Leucovorin+G-CSF+Doxorubicin+ifosfamide+Methotrexate+Rituximab+Vincristine+Cytarabine	hkxkmypbfw(fqcusmgosm) = bdaelxqzby dtpvwvuege (bbmdthcszk, ggxtdqvfzz - ctubmtbggv) View more	-	23 Jul 2025
NCT00476190 (CTgov)	Phase 2	Adult Acute Lymphocytic Leukemia	112	Radiation Therapy+PEG-Asparaginase+Etoposide+doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Pre-amendment Cohort, 2500 IU/m2 q2 Weeks)	ovcifxqkiq = nqqcytllbq ezpjijofqt (lfbigspxtd, mrdypsjvxk - gtsgxkawfl) View more	-	12 Jun 2025
				Radiation Therapy+PEG-Asparaginase+Etoposide+Doxorubicin+Hydrocortisone Sodium Succinate+6-MP+Methotrexate+Cytarabine+Methylprednisone+Cyclophosphamide+Imatinib+Dexamethasone+E. coli Asparaginase+Vincristine (Post-amendment Cohort, 2000 IU/m2 q3 Weeks)	ovcifxqkiq = bgztnqxkdo ezpjijofqt (lfbigspxtd, psbsngdtqq - qtwszfiinu) View more
NCT04548700 (ASCO2025)	Phase 1	Peripheral T-Cell Lymphoma	38	Lipo-MIT combined with COP regimen	djdguaxfgv(euatpmpvba) = feubsmopou rfikvivris (jjneeppeur, 73.3 - 96.8) View more	-	30 May 2025
NCT05453500 (phase II study of DA-EPOCH ± R + tafa for adults with ND Ph- B-ALL, ASCO2025)	Phase 2	Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia CD19+	17	DA-EPOCH + rituximab + tafasitamab	rlgwyqntvu(lbbfrucync) = zakvbklhng ekuibfqliy (neovtrmdbb )	Positive	30 May 2025
				DA-EPOCH + tafasitamab	rlgwyqntvu(lbbfrucync) = vrztuxxxji ekuibfqliy (neovtrmdbb )
GIMEMA LAL1913 (EHA2025)	Phase 2	Adult Lymphoblastic Lymphoma	50	Pegaspargase-based treatment	vubrzenbzi(hccgtlccow) = A better 5-year DFS was observed in patients ≤40 years (80%) when compared with those >40 (56%) kchrcphqcy (cmuoxbixrz ) View more	Positive	14 May 2025
				High cumulative dose (HCD) steroids
Pubmed \| Blood Adv Manual	Not Applicable	Follicular Lymphoma	220	initially treated with bendamustine-rituximab, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) second-line	trbboiezfy(mraibxphig) = dfvzhcoztw bmrmapqeme (fzytghnwsq, 56 - 70) View more	Positive	11 Mar 2025

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