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Biodexa Launches Global Early Access Program for eRapa for FAP Patients Through Strategic Partnership with Tanner Pharma Group
Globenewswire· 2026-03-23 12:30
Core Insights - Biodexa Pharmaceuticals has launched a Global Early Access Program for eRapa, aimed at patients with Familial Adenomatous Polyposis (FAP), through a partnership with Tanner Pharma Group [1][2][3] Company Overview - Biodexa Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing innovative treatments for gastrointestinal cancers [1][7] - The company is headquartered in Cardiff, UK, and has a lead development program for eRapa, which is under development for FAP and Non-Muscle Invasive Bladder Cancer [7][11] Product Information - eRapa is an oral capsule formulation of rapamycin (sirolimus), an mTOR inhibitor, which plays a significant role in cellular metabolism, growth, and proliferation [4][8] - The rationale for using eRapa in treating FAP is supported by the over-expression of mTOR in FAP polyps [4][8] Clinical Development - Biodexa has initiated a double-blind, placebo-controlled Phase 3 trial for eRapa, planning to enroll 168 patients across 30 clinical sites in the US and Europe, with a 2:1 randomization of drug to placebo [4] - The Phase 3 program is backed by a $20 million grant from the Cancer Prevention and Research Institute of Texas [4] Market Context - FAP is characterized by a proliferation of polyps in the colon and/or rectum, typically occurring in mid-teens, with no currently approved therapeutic options available [3] - The incidence of FAP is reported to be one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe [3] Strategic Partnership - The partnership with Tanner Pharma Group aims to provide ethical access to eRapa for FAP patients globally, subject to local regulations and funding availability [2][5]
Biodexa Pharmaceuticals PLC(BDRX) - Prospectus(update)
2025-12-11 21:45
As filed with the U.S. Securities and Exchange Commission on December 11, 2025. Registration No. 333-291598 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) England and Wales 2834 Not Applicable (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (IRS Em ...
Midatech Pharma PLC(MTP) - Prospectus(update)
2025-12-08 21:12
As filed with the U.S. Securities and Exchange Commission on December 8, 2025. Registration No. 333-291598 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Emp ...
Biodexa Pharmaceuticals PLC(BDRX) - Prospectus(update)
2025-12-08 21:12
Registration No. 333-291598 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM F-1 As filed with the U.S. Securities and Exchange Commission on December 8, 2025. REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Emp ...
Biodexa Pharmaceuticals PLC(BDRX) - Prospectus
2025-11-17 22:00
As filed with the U.S. Securities and Exchange Commission on November 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No. ...
Biodexa Announces Recruitment of First Patient in Phase 2 Study of Tolimidone in Type 1 Diabetes
GlobeNewswire News Room· 2025-06-04 12:30
Core Viewpoint - Biodexa Pharmaceuticals PLC has announced the recruitment of the first patient in a Phase 2 study of tolimidone for Type 1 Diabetes, indicating progress in its clinical development pipeline [2][3]. Group 1: Study Details - The Phase 2 study is an Investigator Initiated Trial (IIT) conducted by the University of Alberta Diabetes Institute, focusing on measuring C-peptide levels and HbA1c after three months in 12 patients across three dose groups [3]. - The study aims to assess the number of hyperglycemic events and may expand in the future [3]. Group 2: Drug Background - Tolimidone was originally discovered by Pfizer and developed through Phase II for gastric ulcers but was discontinued due to lack of efficacy [5]. - It is a selective activator of Lyn kinase, which enhances insulin signaling by increasing phosphorylation of insulin substrate-1 [5][8]. - Preclinical studies at the University of Alberta have shown tolimidone's potential to induce beta cell proliferation, which is crucial for insulin production [4]. Group 3: Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including tolimidone for Type 1 Diabetes [6]. - The company's other lead programs include eRapa for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, and MTX110 for aggressive rare/orphan brain cancer [6].
Biodexa Pharmaceuticals PLC(BDRX) - Prospectus
2024-08-12 20:36
Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON AUGUST 12, 2024 THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) Caspia ...