Last update 22 Jun 2024

Dactinomycin

Last update 22 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

2-amino-N,N'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1H-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-3H-phenoxazine-1,9-dicarboxamide, ActD, Actinomycin

+ [15]

Target

DNA

Mechanism

DNA inhibitors(DNA inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesCongenital Disorders+ [5]

Active Indication

Ewing SarcomaRhabdomyosarcomaHodgkin's Lymphoma+ [4]

Inactive Indication

Acute Myeloid LeukemiaGestational Trophoblastic DiseaseLocal Neoplasm Recurrence

Originator Organization

Recordati SpA

Active Organization

Shaanxi Wuzhou Pharmaceutical Co Ltd

Nobelpharma Co., Ltd.

Inactive Organization

Recordati Rare Diseases, Inc.

Actavia Life Sciences, Inc.

Drug Highest PhaseApproved

First Approval Date

US (10 Dec 1964),

Ewing SarcomaGestational Trophoblastic DiseaseLocal Neoplasm Recurrence+ [3]

Regulation-

Structure

Molecular FormulaC62H86N12O16

InChIKeyRJURFGZVJUQBHK-IIXSONLDSA-N

CAS Registry50-76-0

Gene Sequence

Sequence Code 524774375

Clinical Trials associated with Dactinomycin

NCT06401330 / Not yet recruitingPhase 3IIT

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

This phase III trial studies using risk factors in determining treatment for children with favorable tissue (histology) Wilms tumors (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. Previous large clinical trials have established treatment plans that are likely to cure most children with FHWT, however some children still have their cancer come back (called relapse) and not all survive. Previous research has identified features of FHWT that are associated with higher or lower risks of relapse. The term "risk" refers to the chance of the cancer coming back after treatment. Using results of tumor histology tests, biology tests, and response to therapy may be able to improve treatment for children with FHWT.

Start Date12 Jun 2024

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT06023641 / RecruitingPhase 1/2IIT

A Protocol for the Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

This is a phase I-II study to determine safety and efficacy of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients.
Primary Objective
The primary objective of the Phase I part is to estimate the maximum tolerated doses (MTDs) and recommended Phase II doses (RP2Ds) of combining liposomal irinotecan with vincristine alternating with VAC in intermediate-risk patients, liposomal irinotecan with temozolomide and vincristine alternating with VAC in high-risk patients and the chemotherapy combinations when given with concomitant radiation therapy in intermediate and high risk patients.
Estimate event-free survival for intermediate-risk participants treated with VAC and vincristine and liposomal irinotecan (VLI) with the addition of maintenance therapy with vinorelbine and cyclophosphamide.
Estimate the event-free survival for high-risk patients treated with VAC and vincristine, liposomal irinotecan, and temozolomide with the addition of maintenance therapy with vinorelbine and cyclophosphamide.
Estimate the local recurrence rate for unresected intermediate- and high-risk patients with initial tumor size with ≥5 cm randomized to between 59.4 GyRBE and 68 GyRBE total proton radiation dose while receiving VAC/VLI (intermediate-risk) or VAC/VLI plus temozolomide (high-risk) and maintenance therapy.
Secondary Objectives
To assess the relation between pharmacogenetic variation in CEP72 genotype and vinca alkaloid (vincristine; vinorelbine) disposition in children with rhabdomyosarcoma.
To assess the relation between the pharmacogenetic variation in drug metabolizing enzymes and drug transporters, and the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma.
To assess the extent of inter-patient variability in the pharmacokinetics of vinca alkaloids, liposomal irinotecan, and cyclophosphamide in children with rhabdomyosarcoma, and explore possible associations between drug disposition and patient specific covariates (e.g., age, sex, race, weight).
Estimate the cumulative incidence of local recurrence in patients with low-risk disease treated with either no adjuvant radiation or minimal volume radiation.

Start Date13 Mar 2024

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

NCT06028672 / RecruitingNot ApplicableIIT

Efficacy and Safety of Actinomycin-D With or Without Toripalimab as Fist-Line Treatment in Patients With Gestational Trophoblastic Neoplasia With FIGO Score 5-6: A Multicenter, Open-label, Randomized Controlled Trial

Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a higher complete response rate than actinomycin-D alone.
Whether an equally high cure rate can be achieved by multi-drug chemotherapy as second-line treatment in patients who have failed fist-line treatment with toripalimab plus actinomycin-D.
Participants will be allocated into two groups. Those in experimental group will receive toripalimab plus actinomycin-D, while those in control group will receive actinomycin-D alone. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 3 consolidation cycles.

Start Date12 Sep 2023

Sponsor / Collaborator

Peking Union Medical College Hospital

[+6]

100 Clinical Results associated with Dactinomycin

100 Translational Medicine associated with Dactinomycin

100 Patents (Medical) associated with Dactinomycin

17,868

Literatures (Medical) associated with Dactinomycin

01 Mar 2024·Life sciences

Changes in the conflicting nongenomic effects of progesterone in rat myometrium during pregnancy

Article

Author: Yoshida, Aya ; Okada, Hidetaka ; Yasuda, Katsuhiko

AIMS:

Although the functions of progesterone in the myometrium are well-established, the nongenomic effects of progesterone in pregnant myometrial contractions are still unclear. Therefore, this study aimed to investigate changes in the nongenomic effects of progesterone during pregnancy.

MAIN METHODS:

Myometrial strips were obtained from non-pregnant, pregnant, and postpartum rats, and the nongenomic effects of progesterone in the myometrium during pregnancy were examined. Additionally, the influence of actinomycin D and cycloheximide and the effects of Org OD-02-0 (a specific membrane progesterone receptor (mPR) agonist) in the myometrium were investigated. Moreover, DNA microarray and quantitative real-time polymerase chain reaction (qRT-PCR) were performed to identify genes involved in progesterone-induced effects in the myometrium.

KEY FINDINGS:

Progesterone did not cause rhythmic contractions in non-pregnant myometrium but induced rhythmic contractions in pregnant myometrium, with the effects peaking at 20 d + 8 h of pregnancy. However, myometrial contractions decreased after delivery and were restored to non-pregnant levels at 7 d postpartum. Additionally, progesterone stably inhibited high KCl-induced myometrial contractions during pregnancy. Moreover, the nongenomic effects of progesterone were unaffected by actinomycin D or cycloheximide, and Org OD-02-0 effectively mimicked these effects. DNA microarray analysis and qRT-PCR revealed a significant increase in mPRβ gene expression during pregnancy. However, mPRα, mPRγ, mPRδ, and mPRε expression levels remained unchanged.

SIGNIFICANCE:

The stimulatory nongenomic effect of progesterone, which was inducible and mPRβ-dependent during pregnancy, may be involved in parturition. The inhibitory effect, which was constitutive and depended on other mPRs, may be involved in pregnancy maintenance.

01 Mar 2024·Cancer

Prognostic impact of lymph node involvement and loss of heterozygosity of 1p or 16q in stage III favorable histology Wilms tumor: A report from Children’s Oncology Group Studies AREN03B2 and AREN0532

Article

Author: Evageliou, Nicholas ; Vallance, Kelly ; Dome, Jeffrey S ; Perlman, Elizabeth ; Paulino, Arnold ; Varela, Carly R ; Mullen, Elizabeth A ; Ehrlich, Peter F ; Romao, Rodrigo L P ; Geller, James ; Dix, David ; Renfro, Lindsay A ; Eklund, Meryle J ; Kalapurakal, John ; Murphy, Andrew J ; Fernandez, Conrad V

Abstract:

Introduction:

The prognostic impact of positive lymph nodes (LN+) and/or singular loss of heterozygosity (LOH) of 1p or 16q were assessed in children with stage III favorable histology Wilms tumor (FHWT) enrolled on AREN0532 or AREN03B2 alone.

Patients and Methods:

A total of 635 stage III FHWT vincristine/dactinomycin/doxorubicin (DD4A)–treated patients met inclusion criteria. Event‐free survival (EFS) and overall survival are reported overall and by LN sampling, LN status, LOH 1p, LOH 16q, and a combination of LN status and singular LOH. Patients with unknown or positive combined LOH of 1p and 16q status and AREN03B2‐only patients with unknown outcomes or treatment other than DD4A were excluded.

Results:

EFS did not differ by study, supporting pooling. Lack of LN sampling (hazard ratio [HR], 2.12; p = .0037), LN positivity (HR, 2.78; p = .0002), LOH 1p (HR, 2.18; p = .0067), and LOH 16q (HR, 1.72; p = .042) were associated with worse EFS. Compared with patients with both LN– and LOH–, those with negative nodes but positive LOH 1p or 16q and those with LN+ but LOH– for 1p or 16q had significantly worse EFS (HR, 3.05 and 3.57, respectively). Patients positive for both LN and LOH had the worst EFS (HR, 6.33; overall group factor, p < .0001).

Conclusion:

Findings confirm LN+ status as an adverse prognostic factor amplified by presence of singular LOH 1p or 16q, supporting study of intensified therapy for patients with LN+ in combination with singular LOH in a prospective clinical trial.

01 Jan 2024·Pediatric blood & cancer

Significance of fusion status, Oberlin risk factors, local and maintenance treatment in pediatric and adolescent patients with metastatic rhabdomyosarcoma: Data of the European Soft Tissue Sarcoma Registry SoTiSaR

Article

Author: Sparber-Sauer, Monika ; Heinz, Amadeus T ; Fuchs, Jörg ; von Kalle, Thekla ; Seitz, Guido ; Vokuhl, Christian ; Klingebiel, Thomas ; Ljungman, Gustaf ; Münter, Marc ; Pajtler, Kristian W ; Stegmaier, Sabine ; Schönstein, Anton ; Timmermann, Beate ; Ebinger, Martin ; Kratz, Christian P ; Juntti, Hanna ; Koscielniak, Ewa

Abstract:

Background:

Outcome of primary metastatic rhabdomyosarcoma (RMS) is poor. Certain risk factors as fusion status, Oberlin score, and local treatment of primary tumor are known to influence prognosis.

Procedure:

Patients with metastatic RMS were treated according to Cooperative Weichteilsarkom Studiengruppe (CWS) guidance with chemotherapy (CHT), radiotherapy (RT) excluding total lung irradiation (TLI), complete resection of the primary tumor, and metastasectomy if possible. Kaplan–Meier estimators and Cox proportional hazard models were used to examine event‐free survival (EFS) and overall survival (OS) involving also landmark analyses.

Results:

In the European Soft Tissue Sarcoma Registry SoTiSaR (2009–2018), 211 patients were analyzed. Many patients had fusion‐positive alveolar RMS (n = 83; 39%). Median age was 9.4 years [0.1–19.7 years]. Treatment primarily consisted of CHT with CEVAIE (carboplatin, epirubicine, vincristine, actinomycin‐D, ifosfamide, etoposide: 86%, other regimens: 14%), RT (71%), resection of primary tumor (37%), metastasectomy (19%), and lymph node sampling/dissection (21%). Maintenance treatment (MT) (oral trofosfamide, idarubicin, etoposide) was added in 74% of patients. Oberlin factors, fusion status, and MT were predictive for EFS and OS. MT with O‐TIE was not improving outcome when adjusting for the immortal time bias. Local treatment of the primary tumor and radical irradiation (except TLI) improved EFS, not OS, when adjusting for the Oberlin score. Patients with fusion‐negative alveolar RMS (n = 9) had an excellent outcome with a 5‐year EFS and OS of 100%, compared to patients with embryonal RMS (49%/62%), PAX7‐ (22%/47%) and PAX3/FOXO1‐positive ARMS (10/13%), respectively (p < .001).

Conclusions:

Prognosis of metastatic RMS primarily depends on fusion status and Oberlin score. Fusion status needs to be considered in future trials to optimize treatment outcome. The role of radical irradiation needs further investigation.

News (Medical) associated with Dactinomycin

28 Nov 2023

·www.prnewswire.com

Navigating the Evolving Market Dynamics of Bone Sarcoma: A Comprehensive Analysis of Osteosarcoma, Ewing Sarcoma, and Chondrosarcoma | DelveInsight

Each individual's risk of being diagnosed with primary bone sarcoma and their chances of recovery following diagnosis are influenced by a range of unique factors. In 2023, it is anticipated that 4K individuals of all ages in the United States will be diagnosed with primary bone sarcoma, including 2K males and 1.8K females. In 2020, approximately 400 cases were reported among those aged 15 to 19. LAS VEGAS, Nov. 28, 2023 /PRNewswire/ -- Bone sarcoma is a rare and aggressive form of cancer that originates in the bone tissue. It poses significant challenges during its treatment due to several factors. Firstly, its rarity often leads to delayed diagnosis, as symptoms can mimic other common conditions. Additionally, bone sarcoma typically affects children and young adults, making the emotional toll of the disease particularly challenging. Treatment often involves a combination of surgery, chemotherapy, and radiation therapy, which can be physically demanding and cause severe side effects. Moreover, because bone sarcoma tends to occur in the extremities, treatment may require complex and lengthy surgical procedures, potentially affecting mobility and quality of life. Furthermore, the risk of recurrence remains a constant concern, necessitating long-term monitoring and follow-up care. Despite these challenges, ongoing research and advancements in medical technology offer hope for improved outcomes and a better quality of life for those battling bone sarcoma. DelveInsight has recently released a series of epidemiology-based market reports focusing on benign bone sarcoma including Osteosarcoma Market Report, Ewing Sarcoma Market Report, and Chondrosarcoma Market Report. These reports include a comprehensive understanding of current treatment practices, historical and forecasted patient pool, emerging drugs, market share of individual therapies, and historical and forecasted market size from 2019 to 2032 segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Additionally, the reports feature exhaustive analysis of prominent companies working with their emerging candidates in different stages of clinical development. Let's deep dive into the assessment of these bone sarcoma markets individually. Osteosarcoma Market Osteosarcoma is a rare bone tumor affecting having an annual incidence of 3.4 cases per million. It is the most prevalent form of bone cancer, primarily developed in the osteoblast cells of bones, with a predilection for long bones near the knee joint. However, it can also manifest in other locations, including the upper leg, lower leg, upper arm, and virtually any bone in the body, including those in the pelvis, shoulder, and skull. It has the potential to invade adjacent tissues, such as tendons and muscles, and can metastasize to distant organs or other bones via the bloodstream. As per DelveInsight analysts, the total incident population of osteosarcoma in the 7MM was ~2K in 2022. The estimates show the highest incident cases of osteosarcoma in the United States with ~1K cases in 2022, and it is expected to increase by 2032. Osteosarcoma is commonly treated through a combination of chemotherapy, surgery, and radiation therapy. Despite some recent developments, limited progress has been achieved since the late 1980s when chemotherapy was added to surgical treatment, leading to improved survival rates. Radiation therapy impacts both normal and cancerous cells, causing various effects. Chemotherapeutic drugs like cisplatin, doxorubicin, ifosfamide, and high-dose methotrexate with leucovorin calcium rescue (HDMTX) are widely used. Additionally, a few FDA-approved products, such as FUSILEV and KHAPZORY, are available for osteosarcoma treatment. As per DelveInsight analysis, the osteosarcoma market size is expected to increase at a significant CAGR by 2032. This growth would be fuelled by the increase in the patient pool and the expected entry of emerging therapies. Osteosarcoma Pipeline Therapies and Companies Lenvatinib: Eisai Naxitamab: Y-mAbs Therapeutics BAY80-6946: Bayer Vactosertib: MedPacto For a comprehensive view of the osteosarcoma market, check out the Osteosarcoma Market Assessment Ewing Sarcoma Market Ewing Sarcoma, a malignant tumor, typically initiates its growth within the bones, with a higher incidence among children and young adults, often manifesting during adolescence. Although it can originate in any bone, it predominantly affects the long bones, such as the thigh bone, shin bone, and upper arm bone. The pelvis bones are also frequently involved. In some cases, the tumor may originate in muscle and soft tissues. Common symptoms include bone stiffness, pain, swelling, or tenderness, along with tissue surrounding the affected bone. As per the assessment done by DelveInsight, the total incident cases of Ewing sarcoma in the 7MM comprised approximately 1.2K cases in 2022 and are projected to increase during the forecasted period. The management of Ewing sarcoma typically adopts a comprehensive approach, which may encompass surgery, chemotherapy, and radiation therapy. The National Comprehensive Cancer Network (NCCN) offers specific chemotherapy regimens for localized and metastatic Ewing sarcoma. For first-line treatment, NCCN suggests VDC/IE (vincristine, doxorubicin, and cyclophosphamide alternating with ifosfamide and etoposide), VAIA (vincristine, doxorubicin, ifosfamide, and dactinomycin), and VIDE (vincristine, ifosfamide, doxorubicin, and etoposide) for both initial presentations and as primary therapy for metastatic disease. In the second-line setting, NCCN recommends options like Cyclophosphamide and topotecan, Irinotecan + temozolomide ± Vincristine, Ifosfamide, carboplatin, etoposide, and Lurbinectedin. As per the latest Ewing Sarcoma Market Report, the total Ewing sarcoma market size in the 7MM is approximately USD 26 million in 2022 and is projected to increase during the forecast period (2023–2032). The expected introduction of upcoming therapies and the deepened integration of early patient screening, medication management in secondary care, and diverse clinical setups, ongoing research into optimal implementation approaches, and a surge in public awareness will ultimately pave the way for the advancement of efficient treatment choices. Ewing Sarcoma Pipeline Therapies and Companies SECLIDEMSTAT (SP-2577): Salarius Pharmaceuticals ZEPZELCA (LURBINECTEDIN): Jazz Pharmaceuticals and PharmaMar VERZENIO (ABEMACICLIB): Eli Lilly IBRANCE (PALBOCICLIB): Pfizer MECBOTAMAB VEDOTIN (BA3011): Bioatla IOPOFOSINE I 131 (CLR 131): Cellectar Biosciences TP-1287: Sumitomo Pharma Oncology NBRX-109: Inhibrx Explore in-depth for a comprehensive understanding of the Ewing Sarcoma Clinical Trials Chondrosarcoma Market Chondrosarcoma comprises a group of bone tumors originating from cells that overproduce cartilage. Among these tumors, conventional chondrosarcoma is the most frequent type and is generally associated with slow growth. Conversely, rarer subtypes like dedifferentiated chondrosarcoma, myxoid chondrosarcoma, clear cell chondrosarcoma, and mesenchymal chondrosarcoma tend to exhibit a more aggressive growth pattern and have the potential to spread to distant body parts. DelveInsight estimated that the total incident cases of chondrosarcoma in the 7MM comprised approximately 2K cases in 2022 and are projected to increase during the forecasted period. The management approach for chondrosarcoma is contingent upon factors like tumor type, grade, and location, with the grading system serving as the most reliable indicator of clinical prognosis. It is firmly established that surgical intervention remains the gold standard and sole effective treatment for chondrosarcoma, as alternative modalities such as radiotherapy and chemotherapy exhibit limited responsiveness and resistance. Surgical options encompass curettage, radical resection, and amputation, each necessitating comprehensive clinical judgment and contingent upon variables such as lesion size, location, and malignant characteristics. Anticipated advancements in upcoming therapies and increased integration of early patient screening and medication within secondary care and other clinical settings, along with ongoing research to determine the best implementation methods, are expected to contribute to the development of more effective treatment options. However, chondrosarcoma, being an orphan disease, presents challenges in conducting clinical trials. Limited outcome data for locally advanced or metastatic patients underscore the need for new treatment approaches. Phase I trials, due to their small number of chondrosarcoma patients at varying dose levels, make it difficult to draw definitive conclusions. Nevertheless, some Phase II trials have yielded promising results, warranting further investigation. Encouraging retrospective studies could help augment the currently limited data. Urgent efforts to boost research studies on this orphan disease are imperative. As per DelveInsight analysis, the total market size of chondrosarcoma in the 7MM is approximately USD 9 million in 2022 and is projected to increase at a massive CAGR of 24.8% due to increasing awareness of the disease and the launch of the emerging therapy. Chondrosarcoma Pipeline Therapies and Companies INBRX-109: Inhibrx To access a complete analysis of the chondrosarcoma market, visit Chondrosarcoma Market Assessment Trending Oncology Reports Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including EMD Serono, Merck, Cellular Biomedicine Group, Inc., Celgene, CellSight Technologies, Inc., BeyondSpring Pharmaceuticals Inc., J Ints Bio, Forward Pharmaceuticals Co., Ltd., AstraZeneca, Bristol-Myers Squibb, Teligene US, Rain Oncology Inc, ReHeva Biosciences, Inc., Amgen, Novartis, RedCloud Bio, Parexel, Vitrac Therapeutics, LLC, Mythic Therapeutics, Instil Bio, Mirati Therapeutics Inc., Daiichi Sankyo, Inc., AstraZeneca, Precision Biologics, Inc, Promontory Therapeutics Inc., Palobiofarma SL, Regeneron Pharmaceuticals, Revolution Medicines, Inc., Cullinan Oncology, LLC, Iovance Biotherapeutics, Inc., Innate Pharma, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NHL companies, including GAbbVie, Genmab, Novartis, Angiocrine Bioscience, Autolus, Zentera Therapeutics, Jiangsu Hengrui Medicine, among others. Oncolytic Virus Cancer Therapies Market Oncolytic Virus Cancer Therapies Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus cancer therapies companies, including Targovax, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda, among others. Oncology Conference Coverage Services DelveInsight's Oncology Conference Coverage Services deliver a comprehensive examination of conference outcomes from a range of prominent events, such as ASCO, ESMO, ASH, AACR, ASTRO, SOHO, SITC, European CAR T-cell Meeting, and IASLC 2023. This in-depth analysis equips businesses with the insights they need for effective competitive intelligence and forecasting market trends, aiding in the development of future strategies. About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 2Clinical ResultRadiation TherapyASCO

12 Jul 2022

·www.biospace.com

Oncology Pharma Conducting Interviews and Presentations with Investors to Pursue Next Steps to Forward The Development Process of Nanoemulsion Drug Delivery System

SAN FRANCISCO, CA / ACCESSWIRE / July 12, 2022 / Oncology Pharma Inc. (OTC PINK:ONPH) - Oncology Pharma, Inc. ("The Company") is furthering progress in discussions with investors and developing the financing model towards the next step of the development process with its Nanoemulsion drug delivery system. The Company is confident that it will progress towards this next step. The early feasibility study was intended to serve as a demonstration that the development team possessed the capability of formulating research-scale nanoemulsion formulations of dactinomycin. Initial characterization of these formulations would be carried out to demonstrate that the nanoemulsion formulation possessed several desirable characteristics that made them suitable candidates for further nonclinical development. As stated the Company is confident these steps were met and looks forward to moving ahead. Essentially, all of the specific aims under the scope of this project were met. The capability to formulate nanoemulsions that incorporate the active pharmaceutical ingredient, dactinomycin, was demonstrated. Specifically, the study identified two formulations feasible for further development. The capability to be able to innovate and make progress in this early stage demonstrates the team's ability to identify developmental goals and overcome formulation challenges to produce a drug formulation with suitable characteristics for further, formal nonclinical development. These characteristics include the ability for the nanoemulsion to incorporate the majority of available drug into the lipid nanoparticles, a demonstrated release-over-time profile, and stability during storage. Additionally, test methods were established at independent contract laboratories to support basic formulation characterization and accurately detecting the drug concentration in control and test formulations in support of future nonclinical studies. ABOUT ONCOLOGY PHARMA, INC. ONCOLOGY PHARMA, INC. (OTC PINK:ONPH) (the "Company") is currently engaging in research and development of therapeutics for oncology and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare. FORWARD-LOOKING STATEMENTS Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to licensing arrangements and joint ventures, including the need to negotiate the definitive agreements for the relationships; possible failure to realize anticipated benefits of business relationships; and, costs of providing funding to these business relationships. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition; the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; management of growth; and, other risks and uncertainties. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position. CONTACTS: For additional Information, please contact the Oncology Pharma at: One Sansome Street, Suite 3500 San Francisco, CA 94104 Phone: 415-869-1038 Fax: 415-946-8801 website: email: info@oncology-pharma.com SOURCE: Oncology Pharma Inc. View source version on accesswire.com:

08 Jun 2022

·www.biospace.com

Oncology Pharma Announces: Initial Feasibility Study of the Nanoemulsion Drug Delivery System is Complete and Results Have Met the Threshold for Moving Forward To the Next Steps of Development

SAN FRANCISCO, CA / ACCESSWIRE / June 8, 2022 / Oncology Pharma Inc. (OTC PINK:ONPH) - Oncology Pharma, Inc. ("The Company") is pleased that the initial feasibility stage is complete and results have met the threshold to move forward. The formulation under development consisted of the active pharmaceutical ingredient (dactinomycin) encapsulated in a saturated lipid and combined with various emulsifiers, surfactants, and stabilizers. The specific identity and ratios of these ingredients, along with the processing methods and processing parameters utilized, lead to formulations with very different characteristics. Various qualitative assessments (described in the previous section) were performed on the various iterations of the formulations and included: Test for drug incorporation Test for release over time The most promising formulation candidates (i.e., those which demonstrated acceptable feasibility using qualitative assessments) were forwarded to an analytical laboratory for initial characterization, which included: Test for physical properties Tests for formulation drug concentration During the feasibility stage of this project, the Company sought to acquire research and development equipment, establish an early-phase formulation laboratory, verify the capability of developing lipid nanoemulsions, and identify some promising formulations for further development. All goals were successfully accomplished. The data provided a high-level overview of the various formulations that were created and evaluated during this feasibility stage. Essentially, all of the specific aims under the scope of this project were met. The capability to formulate nanoemulsions that incorporate the active pharmaceutical ingredient, dactinomycin, was demonstrated. Specifically, the Company identified two formulations feasible for further development based on the following: The nanoparticle size was approximately 200 nm, which would improve drug delivery at the tumor site. The nanoparticles did not aggregate during storage at 40 C, which enables commercial viability. Dactinomycin incorporation in the nanoparticles was approximately 100% Drug release-over-time study showed about 50% of the drug is retained at 3 hrs. There is 1 mg dactinomycin in 4 ml of nanoemulsion, which is within the range of standard dose administration. The capability to be able to innovate and make progress in this early stage demonstrates the Company's ability to identify developmental goals and overcome formulation challenges to produce a drug formulation with suitable characteristics for further, formal nonclinical development. These characteristics include the ability for the nanoemulsion to incorporate the majority of available drug into the lipid nanoparticles, a demonstrated release-over-time profile, and stability during storage. Additionally, test methods were established at independent contract laboratories to support basic formulation characterization and accurately detecting the drug concentration in control and test formulations in support of future nonclinical studies. Oncology Pharma is committed to finding the path to further development of our licensed technologies and developing the financial model to see this through to the next phases. The Company is reviewing feasibility of some initial applications to the FDA that could enhance the development process. ABOUT ONCOLOGY PHARMA, INC. ONCOLOGY PHARMA, INC. (OTCPK:ONPH) (the "Company") is currently engaging in research and development of therapeutics for oncology and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare. FORWARD LOOKING STATEMENTS Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to licensing arrangements and joint ventures, including the need to negotiate the definitive agreements for the relationships; possible failure to realize anticipated benefits of business relationships; and, costs of providing funding to these business relationships. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition; the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; management of growth; and, other risks and uncertainties. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position. CONTACTS: For additional Information, please contact the Oncology Pharma at: One Sansome Street, Suite 3500 San Francisco, CA 94104 Phone: 415-869-1038 Fax: 415-946-8801 website: email: info@oncology-pharma.com SOURCE: Oncology Pharma Inc. View source version on accesswire.com:

100 Deals associated with Dactinomycin

External Link

KEGG	Wiki	ATC	Drug Bank
D00214	Dactinomycin	L01DA01	DB00970

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hodgkin's Lymphoma	CN	Shaanxi Wuzhou Pharmaceutical Co Ltd	01 Jan 1995
Hodgkin's Lymphoma	CN	-	01 Jan 1995
Neuroblastoma	CN	-	01 Jan 1995
Neuroblastoma	CN	Shaanxi Wuzhou Pharmaceutical Co Ltd	01 Jan 1995
Choriocarcinoma	JP	Nobelpharma Co., Ltd.	16 Dec 1968
Ewing Sarcoma	US	Recordati Rare Diseases, Inc.	10 Dec 1964
Gestational Trophoblastic Disease	US	Recordati Rare Diseases, Inc.	10 Dec 1964
Local Neoplasm Recurrence	US	Recordati Rare Diseases, Inc.	10 Dec 1964
Rhabdomyosarcoma	US	Recordati Rare Diseases, Inc.	10 Dec 1964
Testicular Neoplasms	US	Recordati Rare Diseases, Inc.	10 Dec 1964
Wilms Tumor	US	Recordati Rare Diseases, Inc.	10 Dec 1964

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	IT	Actavia Life Sciences, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


522 (ESGO2024)	Not Applicable	Gestational Trophoblastic Disease Second line	324	5-day ACT-D regimen	ilixnafouz(lqeguqkgbu) = hughkklvbw wyfvkqrnqc (zidfmfucpn ) View more	Positive	10 Mar 2024
				biweekly pulsed ACT-D regimen	ilixnafouz(lqeguqkgbu) = uqqnwxjsoz wyfvkqrnqc (zidfmfucpn ) View more
NCT01535053 (NRG/GOG 275, Pubmed \| Obstet Gynecol Surv)	Phase 3	Gestational Trophoblastic Disease	57	Pulse actinomycin-D	wcvssqsrky(fpkaaqstwt) = ehljqxjphf wyfsqmiscz (fwvpxjlxjp )	Positive	01 Aug 2020
				Multi-day methotrexate	wcvssqsrky(fpkaaqstwt) = neyakgmtlr wyfsqmiscz (fwvpxjlxjp )
ASCO2020	Not Applicable	Ewing Sarcoma First line	-	VAIA combination	pnukisfueq(nckxdiooim) = iidtlmuzrb uspnujoxhw (ssokjtvznw )	Negative	25 May 2020
NCT01014767 (CPT-SIOP-2009, CTgov)	Phase 3	Choroid Plexus Neoplasms \| Brain Cancer	27	Etoposide+Cyclophosphamide+Carboplatin+Vincristine (Standard Arm (1))	oelajapbrs(zwhnonxgpn) = lodwgdyena adtjchvddl (lzkiggpgna, izjfftxozk - scmswgnmqb) View more	-	20 Aug 2019
				Etoposide+Cyclophosphamide+Carboplatin+doxorubicin+Dactinomycin+cisplatin+Vincristine (Doxorubicin/Cisplatin Arm (2))	oelajapbrs(zwhnonxgpn) = okqthtpdpv adtjchvddl (lzkiggpgna, oirunoofmu - hddntimqab) View more
NCT01535053 (NRG/GOG 275, CTgov)	Phase 3	Hydatidiform Mole \| Choriocarcinoma	57	Dactinomycin (Regimen I (Dactinomycin))	zqcoqfsuhb(vqcojswgeb) = xltcjuqxwy jnextuvlzp (ecskmpntbh, ctpyumjvjt - bweylyixdl) View more	-	13 Aug 2019
				Methotrexate (Regimen II (Methotrexate))	zqcoqfsuhb(vqcojswgeb) = gsygsytvss jnextuvlzp (ecskmpntbh, yrtlbuuadu - ssvsewzqsz) View more
EHA2019	Not Applicable	Relapsing acute myeloid leukemia	19	Venetoclax + Low dose cytarabine	cnnifjsknv(wfqmpeoatm) = sepsis (5/19, 26%), pneumonia (5/19, 26%), catheter related infections (3/19, 16%) and febrile neutropenia (3/19, 16%) cfaisphang (gjcglowrnf ) View more	-	14 Jun 2019
NCT00945009 (CTgov)	Phase 3	Wilms Tumor \| Beckwith-Wiedemann Syndrome	249	Therapeutic Conventional Surgery+doxorubicin hydrochloride+Dactinomycin+Vincristine Sulfate (Arm 1 (Bilateral Wilms Tumors))	whxecdocgp(jewmdkbytm) = ocxmelslvd ppfufrsfcs (bzqxyzefum, gamxmznnoo - vushkhhtvu) View more	-	05 Mar 2019
				Therapeutic Conventional Surgery+doxorubicin hydrochloride+Dactinomycin+Vincristine Sulfate (Arm 3 (DHPLN))	syjskeqmlr(rdtstmeckk) = yystummtnr xgziodiccf (ukfacqxwqa, htkbiwzovn - xaasualnbt) View more
NCT00354835 (Pubmed \| J Urol)	Phase 3	Rhabdomyosarcoma	448	Vincristine, Dactinomycin, and Cyclophosphamide (VAC)	hmqzmfouhb(lmakubuefu) = hagyhssrdo rjsbknzwut (ecfesxujby ) View more	-	20 Sep 2018
				Vincristine, Irinotecan, Dactinomycin,Vincristine, Irinotecan, Dactinomycin,Vincristine, Irinotecan, Dactinomycin, and Cyclophosphamide (VAC/VI)	hmqzmfouhb(lmakubuefu) = mlqewmoezw rjsbknzwut (ecfesxujby ) View more
NCT01323517 (CTgov)	Phase 2	Unresectable Melanoma	26	Ipilimumab+Melphalan+Dactinomycin	rkuuhpthht(edqqsaguic) = esopjljzhv hauelqaoef (ztyronqozz, xogzkneyre - mesyxjxkay) View more	-	15 May 2018
NCT00002766 (CTgov)	Phase 3	Acute Lymphoblastic Leukemia \| Lymphoma	170	Mitoxantrone+ARA-C (All-2)	drivqmrqrd(mtkbnlvjnj) = ikzzblgota rdnlldnimr (jmxcazqtlx, eualbfmfct - durftreqje) View more	-	22 Feb 2016
				Prednisone+Vincristine (L-20)	drivqmrqrd(mtkbnlvjnj) = wkbvygyiyh rdnlldnimr (jmxcazqtlx, bvfzssapud - tnuxyqeblz) View more

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