Nanopharmaceutics Announces Initiation of Phase 1b / 2 Clinical Study of Oral Tetrathiomolybdate Capsules with Capecitabine and Pembrolizumab in Triple Negative Breast Cancer Patients at High Risk of Recurrence
October 11, 2024, 8:00 ET
ALACHUA, FL , October 9, 2024 /EIN Pressswire/ -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, announced the initiation of a Phase 1b / 2 clinical study with Dartmouth Health’s Dartmouth Hitchcock Medical "Novel Targeting of the Microenvironment to Decrease Metastatic Recurrence of High-Risk TNBC: A Randomized Phase II Study of Tetrathiomolybdate (TM) plus capecitabine in patients with breast cancer at high risk of recurrence" (ClinicalTrials.gov Identifier: NCT06134375). The primary objective of the phase 1b study will be to establish the safety of the combination of adjuvant tetrathiomolybdate with capecitabine and pembrolizumab administered to patients with triple negative breast cancer after completion of neoadjuvant chemotherapy and with a non-pCR (RCB 2, 3) after standard surgery. The primary objective of the phase 2 study will be relapse-free survival (DRFS) between TM and capecitabine versus capecitabine +/- pembrolizumab. The Principal Investigator is Linda Vahdat, MD MBA, Chief of Medical Oncology and interim Chief of Hematology an Deputy Cancer Center Director at Dartmouth Cancer Center and the study will recruit 204 patients.
Ammonium Tetrathiomolybdate (TM) lowers copper levels in the body. Tetrathiomolybdate has been tested in 22 clinical studies as ammonium tetrathiomolybdate and bis-choline tetrathiomolybdate. The pharmacological class for TM is that of an oral drug which lowers copper levels in the body. TM forms a tripartite complex with copper and protein, eventually cleared primarily by the liver with excretion into the bile. The target indication for usage of TM in this study is in cancer as an anti-metastasis agent. Robust pre-clinical and clinical data in breast cancer suggest that reprogramming of the tumor microenvironment leading to a non-permissive environment for metastases occurs.
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Nanopharmaceutics, Inc. is a wholly-owned subsidiary of TRON Pharmaceuticals, Inc. (OTC:TGRP)
About Dartmouth Hitchcock Medical Center
Dartmouth Hitchcock Medical Center is the state's only academic medical center and the only Level I Adult and Level II Pediatric Trauma Center in New Hampshire. The Dartmouth Cancer Center is 1 of 57 NCI designated Comprehensive Cancer Centers (CCC) and the only CCC in northern New England.
Nanopharmaceutics and Northwestern University Announce Initiation of Phase I Adaptive Dose Escalation Clinical Study with Dose Expansion of Oral Triapine® in Combination with Temozolomide (TMZ) for Patients with Recurrent Glioblastoma
May 14, 2024, 16:30 ET
ALACHUA, Fla. and CHICAGO, May 14, 2024 /PRNewswire/ -- Nanopharmaceutics, Inc. (OTC:TGRP), a clinical-stage pharmaceutical development company, announced the initiation of a Phase I clinical study with the Robert H. Lurie Comprehensive Cancer Center of Northwestern University "A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide (TMZ) for Patients With Recurrent Glioblastoma" (ClinicalTrials.gov Identifier: NCT06410248). The primary objective of this phase 1 study will be to determine the recommended phase 2 dose (RP2D) for Triapine® in combination with temozolomide (TMZ). Secondary objectives include evaluation of the safety profile of Triapine® in combination with temozolomide (TMZ), progression-free survival (PFS), overall survival (OS), overall response rate (ORR) per RANO criteria, and quality of life per FACT-Br. The study will recruit 40-45 patients with an established diagnosis of recurrent glioblastoma, and there will be an exploratory arm to investigate drug delivery into brain tumor tissue and target engagement in a cohort who are surgical candidates for re-resection of recurrent glioblastoma. Funding for the study is provided by BrainUp.
Oral Triapine® has been shown to be safe, tolerable, and convenient in multiple clinical studies. Ribonucleotide Reductase (RNR) Regulatory Subunit 2 (RRM2) targeting with Triapine® may overcome chemoresistance and improve the clinical efficacy of TMZ therapy. Preliminary research from Dr. Atique Ahmed's lab at Northwestern University has uncovered a critical factor that helps glioblastoma, an aggressive brain cancer, resist chemotherapy treatment.
About the Robert H. Lurie Comprehensive Cancer Center of Northwestern University
The Robert H. Lurie Comprehensive Cancer Center of Northwestern University is a National Cancer Institute-designated Comprehensive Cancer Center located on Northwestern Memorial Hospital's downtown medical campus in the Streeterville neighborhood of Chicago, Illinois, United States.
About BrainUp
BrainUp is a nonprofit founded by Dan & Meg Kresach of Frankfort, Illinois. They founded BrainUp after their only child Olivia, was diagnosed 10 years ago with a Glioblastoma at the age of 22 years old. She died on April 19, 2014. The Kresachs formed BrainUp to fund brain cancer research. They have an annual run/walk to raise money for brain cancer research. They have funded over 1.2 million dollars supporting brain cancer research and trials at Chicago healthcare institutions. BrainUp is the financial supporter of Karan Dixit, M.D. (PI) and Atique Ahmed, Ph.D of Northwestern University Chicago, Illinois. To learn more about BrainUp, visit brainup.ngo
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver BCS category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability.
Contact:
Nanopharmaceutics, Inc. (OTC: TGRP)
James D. Talton, Ph.D.
President and Chief Executive Officer
386-401-6304
www.nanopharmaceutics.com
SOURCE Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. Announce Definitive Merger and Reorganization Agreement
February 16, 2024
Nanopharmaceutics, Inc. (OTC PINK:TGRP) and Nanopharmaceutic Holdings, Inc., announced signing of a definitive agreement for the merger and reorganization combining Nanopharmaceutic Holdings, Inc. with NANOP Acquisition II, Inc. ("NANOP"), a wholly-owned Nanopharmaceutics, Inc. subsidiary, in an all-stock transaction. Before the transaction, Nanopharmaceutic Holdings, Inc. held a minority stake in Alchem Laboratories Corporation, a research and development company manufacturing products for clinical trials based in Florida. Following consummation of the Merger, Nanopharmaceutics, Inc. becomes a vertically-integrated clinical-stage pharmaceutical company with a minority stake in Alchem Laboratories Corporation and will continue to trade on the OTC Pink market. The combined company's headquarters are located in Alachua, Florida. The Company intends to file a corporate action with FINRA with respect to the change.
https://www.otcmarkets.com/otcapi/company/financial-report/392596/content
Nanopharmaceutics issued US patent 11,725,016 "Compositions and Methods for Oral Delivery of Crystalline PRX-3140 Potassium Salt"
August 16, 2023 / James Talton
The present disclosure addresses this need by providing crystalline fine particle forms of PRX-3140 potassium salt, methods for preparation and the treatment for Alzheimer's disease (AD) and other dementias affecting the cholinergic and/or serotonergic systems including post-traumatic stress disorder (PTSD). In certain aspects, the present disclosure provides novel methods of preparing the compound of Formula I thereof, or PRX-3140 potassium salts, crystalline fine particle forms of PRX-3140 potassium salt, and compositions comprising them. In certain aspects, the present disclosure provides novel crystalline fine particle form of PRX-3140 potassium salt which may provide advantages including improved bioavailability and stability relative to other crystalline or amorphous forms. In other aspects, the present disclosure provides oral dosage forms of crystalline fine particle form of PRX-3140 potassium salt and excipients with improved stability. In additional aspects, the present disclosure provides novel methods of synthesizing novel crystalline fine particle form of PRX-3140 potassium salt, preparing crystalline PRX-3140 potassium salt particle delivery systems (PDS), and preparing novel final dosage forms (FDF) of crystalline fine particle PRX-3140 potassium salt. In certain aspects, the present disclosure provides novel crystalline forms of fine particle PRX-3140 potassium salt which may provide advantages including improved bioavailability and stability relative to other crystalline or amorphous forms.
PrecisionLife announces strategic CNS drug development collaboration with Nanopharmaceutics
Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS portfolio.
Agreement to utilize PrecisionLife’s combinatorial analytics platform to identify genetic biomarkers that will optimize patient selection across multiple CNS clinical trials.
Oxford, UK, and Alachua, US, 15 June 2023 – PrecisionLife, a leading techbio company driving precision medicine into complex chronic diseases, and Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, announced today a strategic collaboration aiming to accelerate and de-risk the development of Nanopharmaceutics’ portfolio of central nervous system (CNS) assets.
The collaboration will leverage PrecisionLife’s proprietary combinatorial analytics platform to analyze patient genomic profiles and identify target-specific genetic biomarkers for each of Nanopharmaceutics’ CNS drug development programs. These biomarkers will be based on combinations of single nucleotide polymorphisms (SNPs) specifically associated with Nanopharmaceutics’ drugs’ mechanisms of action and the development indication.
As part of the collaboration, PrecisionLife will support Nanopharmaceutics in the clinical development of their CNS programs by identifying patient stratification biomarkers to link the development compounds’ mechanisms of action to the patient subgroups with the highest likelihood of demonstrating positive outcomes in clinical trials, optimizing patient selection. The terms of the collaboration also include an option for Nanopharmaceutics to negotiate an exclusive right to the patient stratification biomarkers discovered through the PrecisionLife platform.
This precision medicine approach has the potential to significantly increase the probability of clinical trial success rates, even in the most complex chronic diseases. Beyond the applications set out in this collaboration, PrecisionLife biomarkers may also serve as invaluable complementary diagnostic tools, expediting the approval of new therapeutic products and facilitating the swift delivery of the latest medicines to patients with unmet medical needs.
Commenting on the collaboration, James Talton, PhD, President and CEO of Nanopharmaceutics, stated: "We're thrilled to partner with PrecisionLife, a company that shares our commitment to creating targeted therapeutic products for patients. By leveraging PrecisionLife’s innovative approach, Nanopharmaceutics aims to enhance the precision and effectiveness of clinical trials for CNS disorders, which have historically presented numerous challenges due to their complexity.”
Steve Gardner, PhD, CEO and Co-founder of PrecisionLife, added: "PrecisionLife excels in the identification of the combinations of genetic and non-genetic features responsible for an individual’s disease subtypes, enabling the design of smaller, faster-to-readout clinical trials targeted at each drug's mechanism of action. We're delighted to support Nanopharmaceutics in their clinical development with precision biomarkers, accelerating and de-risking the development of targeted therapeutic products for patients who urgently need them."
This collaboration between PrecisionLife and Nanopharmaceutics marks a significant milestone in the pursuit of precision medicine for complex chronic diseases, by using mechanistic patient stratification biomarkers to inform clinical trial design and transform the lives of patients.
For further press information please contact:
Noah Konig, Marketing Director, Precision Life
noah@precisionlife.com / +44 (0)1865 575170
About PrecisionLife
PrecisionLife is a pioneering techbio company changing the way the world predicts, prevents, and treats chronic disease.
Our mission is to find better, more personalized treatment options for patients with unmet medical needs - driving precision medicine beyond oncology and rare diseases, into complex common diseases that account for over 80% of healthcare spending.
Our innovative combinatorial approach allows us to uncover the deepest insights into disease biology and achieve mechanistic patient stratification even in the most heterogeneous conditions.
With a vast repository of information and intellectual property spanning over 45 indications, we have developed one of the most extensive pipelines for precision targeted therapies. This wealth of knowledge empowers us to inform and de-risk every stage of biopharma innovation, from initial concept to the clinic.
To learn more about our groundbreaking work, please visit us at precisionlife.com. Connect with us on LinkedIn at @PrecisionLifeAI and follow us on Twitter at @PrecisionLifeAI.
About Nanopharmaceutics, Inc. (OTC: TGRP)
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver Biopharmaceutics Classification System (BCS) category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability.
Nanopharmaceutics, Inc. Announces a Phase 2 Clinical Study “Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors“ with NCI and Ohio State University Comprehensive Cancer Center
ALACHUA, Fla., March 18, 2023 -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, today announced the 94 patient Phase 2 clinical study “Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors“ led by Aman Chauhan at Ohio State University Comprehensive Cancer Center (ClinicalTrials.gov Identifier: NCT05724108). The phase 2 trial will compare the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone.
Nanopharmaceutics, Inc. Announces Initiation of Patient Recruitment for a Phase 2 Clinical Study “Investigation of Laser Assisted Drug Delivery of NanoDOX®“ with Massachusetts General Hospital Cutaneous Biology Research Center
ALACHUA, Fla., March 18, 2023 -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, today announced initiation of patient enrollment in the 12 patient Phase 2 pilot clinical study “Investigation of Laser Assisted Drug Delivery of NanoDOX®“ led by Dieter Manstein, MD at Massachusetts General Hospital Cutaneous Biology Research Center (ClinicalTrials.gov Identifier: NCT05411484). The pilot phase 2 trial will evaluate an ablative fractional CO2 laser procedure followed by topical application of NanoDOX® Hydrogel to evaluate the effects on wound healing. Nanopharmaceutics proprietary formulation of NanoDOX® 1% Doxycycline Monohydrate Hydrogel is currently under development for skin wounds and atopic dermatitis.
Nanopharmaceutics, Inc. Announces the End of Patient Recruitment for the National Cancer Institute (NCI) Sponsored Phase 3 Clinical Study in Advanced-Stage Cervical and Vaginal Cancers with Cisplatin During Radiation Therapy with and without Triapine®
ALACHUA, Fla., Nov. 2, 2022 /PRNewswire/ -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, today announced completion of patient enrollment in the 450 patient Phase 3 clinical study sponsored by the NCI, part of the National Institutes of Health, and led by NCI funded network group, NRG Oncology, with participation of the NCI National Clinical Trials Network (NCTN), "A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal," (NRG-GY006, ClinicalTrials.gov Identifier: NCT02466971). The randomized phase 3 trial is evaluating radiation therapy and cisplatin with Nanopharmaceutics' proprietary formulation of Triapine® compared to the standard radiation therapy and cisplatin, alone, in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors.
Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Triapine® may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with Triapine® Injection in treating cervical or vaginal cancer. 450 patients were enrolled in the study, which was performed under a Cooperative Research and Development Agreement (CRADA) between NCI and Nanopharmaceutics.
About Triapine®
Triapine® is a synthetic heterocyclic carboxaldehyde thiosemicarbazone with potential antineoplastic activity being studied in the treatment of cancer. It is a type of ribonucleotide reductase inhibitor. Also called 3-aminopyridine-2-carboxaldehyde thiosemicarbazone and 3-AP, Triapine® inhibits the enzyme ribonucleotide reductase, resulting in the inhibition of the conversion of ribonucleoside diphosphates to deoxyribonucleotides necessary for DNA synthesis.
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver Biopharmaceutics Classification System (BCS) category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability.
TRON Group, Inc. and Nanopharmaceutics, Inc. Announce Definitive Merger Agreement
Eagle, Idaho and Alachua, FL, August 11, 2022 -- TRON Group, Inc. (OTC PINK:TGRP) (“TRON” or “the Company”) and Nanopharmaceutics, Inc. (“Nano”), a privately-held clinical-stage pharmaceutical development company incorporated in Florida, announced today the signing of a definitive agreement for the merger of Nano with NANOP Acquisition Corp, Inc. ("NANOP"), a wholly-owned TRON subsidiary, in an all-stock transaction. Following consummation of the Merger, TRON will change its name to Nanopharmaceutics, Inc. and will continue to trade on the OTC Pink market.
Details of Proposed Merger
The merger was unanimously approved by both Boards of Directors of TRON and Nano. Under the terms of the agreement, in an all-stock transaction, Nano and NANOP will merge. TRON will issue five shares of recently authorized and designated Class A Preferred stock to Nano shareholders in exchange for all the issued and outstanding shares of Nano. The Company intends to file a corporate action with FINRA in respect of the aforementioned name change.
James D. Talton, Ph.D., President and Chief Executive Officer and controlling shareholder of both TRON and Nanopharmaceutics, has been appointed Chief Executive Officer, President, Secretary/Treasurer and Director of TRON, effective August 8, 2022. The Board of Directors will initially be comprised of three members including current TRON directors, Quoc Tuan (Jacob) Nguyen and Stephen Michael Griffith. Jr., and Dr. Talton, who will also continue to serve as an officer and director of Nano. The combined company's headquarters will be located in Alachua, Florida.
Immediately prior to the Merger Agreement, TRON entered into an agreement to terminate its common control relationship with Impression VFX Inc., including the extinguishment of a convertible note in exchange for the return of certain assets, and the termination of a service agreement.
Clinical Stage Product Pipeline
The new company’s pipeline includes 10 clinical-stage (phase 1 through phase 3), proprietary and partnered programs including Triapine®, Ammonium Tetrathiomolybdate and Aza-TdC, targeting cancer; NanoBUP™, PRX-3140, NP-18-2, and NP-18-3, targeting CNS; and Ramoplanin™ and NanoDOX™, targeting infectious disease. The company is also advancing a large, undisclosed portfolio of preclinical development candidates.
Important Additional Information about Proposed Merger
This communication is being made in respect of the merger involving TRON Group, Inc. and Nanopharmaceutics, Inc. TRON Group will file a material event notice with the OTC Pink Market. This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in connection with the proposed merger shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
About TRON Group, Inc.
TRON Group Inc. is a holding company acquiring operating companies and assets in growing industries. The company’s intent is to grow them by providing management and technical support under its public company umbrella.
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Leveraging its expertise in nanoparticle and fine-particle formulations, which can specifically be used to improve hard-to-deliver BCS category II and IV drugs, Nanopharmaceutics is focused on formulation development aimed at improving drug absorption and stability.
Forward-Looking Statements:
Legal Notice Regarding Forward-Looking Statements in this news release that are not historical facts are forward-looking statements that are subject to risks and uncertainties. Forward-looking statements are based on current facts and analyses and other information that are based on forecasts of future results, estimates of amounts not yet determined, and assumptions of management. Forward looking statements are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "aims", "potential", "goal", "objective", "prospective", and similar expressions or that events or conditions "will", "would", "may", "can", "could" or "should" occur. Actual results may differ materially from those currently anticipated due to a number of factors beyond the reasonable control of the Company. It is important to note that actual outcomes and the Company's actual results could differ materially from those in such forward-looking statements. Factors that could cause actual results to differ materially include misinterpretation of data, the Company's ability to raise financing for operations, breach by parties with whom we have contracted, and the possible inability to maintain qualified employees or consultants.
Contact:
Nanopharmaceutics, Inc.
James D. Talton, Ph.D.
President and Chief Executive Officer
352-256-6266
jtalton@nanopharmaceutics.com
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