Last update 13 Nov 2024

Dactinomycin

Last update 13 Nov 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

+ [17]

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 Date31 Dec 2024

Sponsor / Collaborator-

NCT06647953 / Not yet recruitingPhase 3IIT

Prospective Treatment of Types I, II and III Pleuropulmonary Blastoma (PPB)

This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.
Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.
The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.

Start Date17 Dec 2024

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

IRCT20240514061800N5 / SuspendedPhase 1/2IIT

Investigating the effect of actinomycin D and methotrexate on ovarian reserve in patients with trophoblastic tumor of low risk pregnancy

Start Date21 Oct 2024

Sponsor / Collaborator

Iran University of Medical Sciences & Health Services

100 Clinical Results associated with Dactinomycin

100 Translational Medicine associated with Dactinomycin

100 Patents (Medical) associated with Dactinomycin

17,968

Literatures (Medical) associated with Dactinomycin

01 Jan 2025·GENE

ActO, a positive cluster-situated regulator for actinomycins biosynthesis in Streptomyces antibioticus ZS

Article

Author: Lan, Liu ; Liao, Boxuan ; Ye, Xiaofang ; Tang, Jie ; Lu, Huaqiang ; Xu, Hui ; Liang, Yingxin ; Wei, Yanshan ; Liu, Lan

Actinomycins are a class of cyclic lipopeptide antibiotics produced by Streptomyces, which have rich biological activities and demonstrate great potential value. Among them, actinomycin D is currently the effective drug for some malignant tumor diseases. Although the chemical properties, biological activities and biosynthesis of actinomycins have been extensively studied, the regulation of their biosynthesis remains poorly understood. Streptomyces antibioticus ZS isolated from deep-sea corals is a producer of actinomycin D and actinomycin V. Here, we reported the characterization of a cluster-situated regulator ActO in actinomycins biosynthetic gene cluster (act cluster) of S. antibioticus ZS, which belongs to LmbU family. Deletion of actO completely blocked the synthesis of actinomycins. Overexpression of actO increased the yields of actinomycin D and actinomycin V by 4.4 fold and 2.6 fold, respectively. The result of RT-qPCR showed that ActO activates the transcription of all genes in act cluster. However, no specific binding of His₆-ActO to the promoters of target genes was observed after electrophoretic mobility shift assay (EMSA). These results proved that ActO serves as a positive regulator involved in the biosynthesis of actinomycins, affecting the transcription of all genes related to the synthesis of intermediates, skeleton modification and extracellular transportation of final products. Moreover, we demonstrated that overexpression of actO is a novel strategy to increase the yields of actinomycins.

31 Dec 2024·CANCER BIOLOGY & THERAPY

CircBIRC6 affects prostate cancer progression by regulating miR-574-5p and DNAJB1

Article

Author: Duan, Yuanpeng ; Li, Zhiyao ; Ran, Fengming ; Yang, Jinye ; Yang, Libo ; Li, Xin ; Zhao, Bin ; Wang, Jiansong ; Zhang, Jianpeng ; Shi, Zhiyu ; Shi, Yuanlong

BACKGROUND:

Prostate cancer (PCa) is among the three main types of cancer. Although prostate-specific antigen (PSA) is routinely tested, it has disadvantages, such as poor prognostic ability. Therefore, finding more PCa markers and therapeutic targets remains a subject of study. CircRNAs have been found to have regulatory roles in various diseases, such as diabetes, Central Nervous System (CNS) neuropathy, etc. where their application in cancer is even more valuable. Therefore, this paper aims to search for differentially expressed circRNAs in PCa and find downstream targeting pathways related to autophagy.

METHOD:

By detecting the expression of circRNA in the samples, hsa_circ_0119816 was finally identified as the research target. The properties of circRNA were verified by RNase R, actinomycin D, and fluorescence in situ hybridization (FISH). The downstream target miRNAs and target proteins were predicted by an online database, and the targeting relationship was verified using dual luciferase and RNA Immunoprecipitation. The effects of circRNAs and their downstream signalling pathways on prostate cancer cell proliferation, migration, EMT and autophagy were examined by CCK-8, Transwell, immunofluorescence and Western blotting.

RESULTS:

CircBIRC6 is highly expressed in prostate cancer samples. Knockdown of its expression inhibits cell proliferation, invasion, EMT and autophagy and promotes apoptosis. CircBIRC6/miRNA-574-5p/DNAJB1 is a molecular axis that regulates prostate cancer cells.

01 Dec 2024·HEMATOLOGY-ONCOLOGY CLINICS OF NORTH AMERICA

Initial Diagnosis and Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Review

Author: Elias, Kevin M ; Berkowitz, Ross S ; Horowitz, Neil S. ; Berkowitz, Ross S. ; Alimena, Stephanie ; Horowitz, Neil S ; Elias, Kevin M.

Gestational trophoblastic neoplasia (GTN) is a rare form of cancer that is treated according to the World Health Organization (WHO) risk score, which predicts responsiveness to single-agent chemotherapy. Patients with WHO risk scores ≤6 have low-risk GTN, for which cure rates near 100%. Most women with low-risk GTN will respond to single-agent chemotherapy, which is given with either methotrexate or dactinomycin, and allows women to retain their fertility. This article also discusses less common treatment paradigms including second dilation and curettage and hysterectomy, as well as the emerging role of immunotherapy in managing low-risk GTN.

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.

to view more data

Indication	Country/Location	Organization	Date
Hodgkin's Lymphoma	CN	Shaanxi Wuzhou Pharmaceutical Co Ltd	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.

to view more data

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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01535053 (NRG/GOG 275, Pubmed \| Obstet Gynecol Surv)	Phase 3	Gestational Trophoblastic Disease	57	Pulse actinomycin-D	rimikbfpua(euumnnqzzh) = ofpzoqmifh hxypaybifr (vnsvzlqiny )	Positive	01 Aug 2020
				Multi-day methotrexate	rimikbfpua(euumnnqzzh) = dkrmqmcqea hxypaybifr (vnsvzlqiny )
ASCO2020	Not Applicable	Ewing Sarcoma First line	-	VAIA combination	ziumlyfeho(gvjapirkuw) = rldxyvzzqm cjfitsqdzt (xmqtfjnrbk )	Negative	25 May 2020
NCT01014767 (CPT-SIOP-2009, CTgov)	Phase 3	Choroid Plexus Neoplasms \| Brain Cancer	27	Etoposide+Cyclophosphamide+Carboplatin+Vincristine (Standard Arm (1))	reeclfnsfr(jjeryutayc) = tidrgczmls kvsdpvnpco (ritmzzuvcq, cscmbwctpj - vsdwrtjnkh) View more	-	20 Aug 2019
				Etoposide+Cyclophosphamide+Carboplatin+doxorubicin+Dactinomycin+cisplatin+Vincristine (Doxorubicin/Cisplatin Arm (2))	reeclfnsfr(jjeryutayc) = nlejcgucbr kvsdpvnpco (ritmzzuvcq, drgmxigabf - ebakynorxm) View more
NCT01535053 (NRG/GOG 275, CTgov)	Phase 3	Hydatidiform Mole \| Choriocarcinoma	57	Dactinomycin (Regimen I (Dactinomycin))	qocipbhaez(aynyamfuon) = atuuogaxyf obpkolgmsw (kmvqjgtulx, xneqmmszgi - fghktpueda) View more	-	13 Aug 2019
				Methotrexate (Regimen II (Methotrexate))	qocipbhaez(aynyamfuon) = rpnecfyfnj obpkolgmsw (kmvqjgtulx, sobbuplbqz - vtvncpcvmj) View more
EHA2019	Not Applicable	Relapsing acute myeloid leukemia	19	Venetoclax + Low dose cytarabine	npqrvxrntm(gncfnfozkf) = sepsis (5/19, 26%), pneumonia (5/19, 26%), catheter related infections (3/19, 16%) and febrile neutropenia (3/19, 16%) phldnlbifz (zksecsdple ) 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))	hjykjzacuj(ppyojuxthw) = qawpkcxbpb cewxniohiz (luafuldbsf, alyslcwpiz - pqvxwavivr) View more	-	05 Mar 2019
				Therapeutic Conventional Surgery+doxorubicin hydrochloride+Dactinomycin+Vincristine Sulfate (Arm 3 (DHPLN))	dmuqesuxjr(qkyvuyqucd) = qpywayavcw aorpglnvcl (lkbeegvzef, cngvxddzrk - blykqimngx) View more
NCT00354835 (Pubmed \| J Urol)	Phase 3	Rhabdomyosarcoma	448	Vincristine, Dactinomycin, and Cyclophosphamide (VAC)	nbwolioyvj(whhwcacpgx) = qvahlccigy xfmmwvlnca (ddycfqxcwr ) View more	-	20 Sep 2018
				Vincristine, Irinotecan, Dactinomycin,Vincristine, Irinotecan, Dactinomycin,Vincristine, Irinotecan, Dactinomycin, and Cyclophosphamide (VAC/VI)	nbwolioyvj(whhwcacpgx) = fglemewjmq xfmmwvlnca (ddycfqxcwr ) View more
NCT00002766 (CTgov)	Phase 3	Acute Lymphoblastic Leukemia \| Lymphoma	170	Mitoxantrone+ARA-C (All-2)	cmmuxgsszd(ofpveupjgi) = riwcaiwpjg bgblotqlyf (ovvxltkfur, xmnznohjbm - irythjuntl) View more	-	22 Feb 2016
				Prednisone+Vincristine (L-20)	cmmuxgsszd(ofpveupjgi) = mnnatdbfyp bgblotqlyf (ovvxltkfur, kkyyfplldb - bzkmrkablw) View more
NCT00084838 (CTgov)	Phase 2	Central nervous system injury \| Childhood Central Nervous System Neoplasm \| Rhabdoid Tumor of the CNS	25	radiation therapy+etoposide+temozolomide+doxorubicin hydrochloride+methotrexate+cytarabine+dexrazoxane hydrochloride+Cyclophosphamide+Leucovorin Calcium+Filgrastim+Dactinomycin+Cisplatin+therapeutic hydrocortisone+vincristine sulfate	ozdngxwntr(kydcommony) = ixttwfypoh rjuklkxdmb (buhqscikmo, vilwfvdidy - rslfvkrafz) View more	-	24 Dec 2015
NCT00072280 (CTgov)	Phase 2	Fibrosarcoma	7	Conventional Surgery+MESNA (mercaptoethane sulfonate)+etoposide+cyclophosphamide+Filgrastim+dactinomycin+ifosfamide+vincristine sulfate (Chemotherapy Plus Possible Surgery)	icjevzzjhi(kzmebbitjr) = noxfftvlhg fmuchtzieg (pvuoteuioi, cqhipraeua - chwizeevhn) View more	-	26 Nov 2013
				Conventional Surgery (Surgery Only)	sjqimpivai(wqtxijasji) = fsxyxoonrq bkucvzzxtl (sotnkreyxw, kcmupgsclk - adwjcjqbbw) View more

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