Midatech Ltd., a global leader in the design, synthesis and manufacture of nanomedicines based on its passivated gold-nanoparticle technology, and MonoSol Rx LLC, the developer of PharmFilm® drug delivery technology, today announced positive bioavailability and pharmacokinetic results from a first-in-human Phase 1 clinical study of their MidaformTM Insulin PharmFilm product in 27 healthy volunteers. The companies have licensed to their joint venture company, MidaSol Therapeutics LLC, a proprietary nanoformulated transbuccal insulin film product, which delivers monomeric insulin through the use of a rapidly dissolving mucoadhesive film that is placed onto the inside of the cheek.

Insulin, stabilized on a nanoparticle and delivered transbuccally, has the potential to offer diabetic patients a viable oral alternative to injectable insulin. The Phase 1 study established Midaform Insulin PharmFilm as a safe, novel, non-injectable insulin delivery system, which closely mimicked the delivery characteristics of monomeric insulin from the pancreas. Importantly, MidaSol’s product showed a faster onset of action compared to subcutaneous insulin. Top-line results, including PK and bioavailability elements, from the study will be presented at the European Summit for Clinical Nanomedicine (CLINAM) in Basel, Switzerland by Prof.Dr. med. Fritz R. Bühler, Chief Medical Officer and member of the Board of Midatech Ltd.

A. Mark Schobel, Co-President and CEO of MonoSol Rx, said “These results are as good as we could have hoped for in terms of insulin bioavailability and pharmacokinetics following administration of Midaform Insulin Pharmfilm. The rapid onset of action surpassed our expectations and we look forward to further clinical development of this exciting and new groundbreaking product. Based on the success of this in-man study, which unequivocally validates the utility of our diverse pre-clinical animal models, we look forward to accelerating the entire product development program.”

Professor Thomas Rademacher, CEO and Chairman of Midatech, remarked: “The success of Midaform Insulin PharmFilm demonstrates its safety, tolerability and potential use in treating diabetes, particularly meal-dependent hyperglycemia. This study is a significant step forward for the commercialization of this novel, non-injectable insulin formulation. This trial shows the success of the MidaSol Therapeutics LLC joint venture between Midatech and MonoSol, and brings us closer to using nanomedicines in clinical practice.”

The post Positive Phase 1 Clinical Results for Novel Transbuccal Oral Insulin Film Product appeared first on Midatech.

The post 5th European CLINAM conference for clinical nanomedicine appeared first on Midatech.

The post SACHS European Life Science CEO Forum for Partnering & Investing appeared first on Midatech.

Strategic Initiative Focused on Partnering/Licensing of Innovative Diabetes Therapies

Combines Monosol Rx’ Proprietary PharmFilm® and Midatech’s Proprietary MidaFormTM Nanoparticle Technologies

The post MonoSol Rx and Midatech Launch MidaSol Therapeutics LP appeared first on Midatech.

Midatech Ltd., a global leader for the design, development, synthesis and manufacture of nanomedicines, announced today it has raised £6.3 million through a private investment round.

This financing will be used to strengthen and diversify Midatech’s product development portfolio, especially in oncology. It will be used to support clinical development of chemotherapeutic gold nanoparticles designed to target ovarian, lung and breast carcinoma and to support development of therapeutic cancer vaccines in SynTara, a joint venture with Immunotope Inc. The funding will also be used to expand the capacity of Midatech’s resources to accommodate its expanding development portfolio. In November 2011, Midatech received regulatory approval for a first-in-human study of MidaFormTM insulin delivered transbuccally. Phase I results are expected in Q1 2012.

“This funding reflects on the excellent work that Midatech has achieved in advancing its programs through preclinical development and targeting specific compounds for drug delivery by gold nanoparticles”, commented Prof. Thomas Rademacher, CEO and Chairman of Midatech, adding, “In addition to its advanced diabetes program currently being commercialized in MidaSol Therapeutics LP, a joint venture with MonoSol Rx, Midatech is now well funded to expand its activities to encompass other disease indications, by initiating several programmes in oncology.”

Midatech is a world leader in the design, synthesis and manufacture of biocompatible nanoparticles. These nanoparticles can be used to create a wide variety of products with novel characteristics, functions and applications for a number of industry segments including life sciences, electronics and fine chemicals.

The post Midatech secures £6.3 Million Financing to Strengthen Product Development Portfolio appeared first on Midatech.

Midatech Ltd., a global leader in the design, development, synthesis and manufacture of nanomedicines, announced today it has received Swissmedic approval to start the First-in-Human clinical trial with insulin-coated gold nanoparticles, which will be coordinated through its Swiss subsidiary PharMida AG.

The trial is designed to assess the safety profile of insulin-coated gold nanoparticles when applied in transbuccal film to healthy volunteers. The study will be performed in a clinical research unit near Basel, Switzerland and results of the trial are expected during Q1 2012.

Midatech has developed ultra-small gold nanoparticles (GNP, < 2 nm) that act as artificial atoms that are covalently surface-passivated with a mixed carbohydrate/organic layer (corona). The corona is designed to non-covalently bind and stabilise multiple copies of bioactive peptides like insulin and glucagon-like peptide-1 (GLP-1). Extensive pre-clinical studies with GNP and peptide-GNP have demonstrated favourable PK properties and a clean safety profile in studies with single and multiple dosing by oral, intravenous, subcutaneous and transbuccal route in various animal species.

“This is the first time that solid core nanoparticles of this size and nature will enter human clinical trials,” Thomas Rademacher, CEO and Chairman of Midatech Group said, adding: “Based on the excellent preclinical and toxicology results obtained for Midatech’s gold nanoparticles in multiple animal models, we are pleased to move to the next stage of development and test the safety of our nanoparticles in human clinical trials. We are also pleased that our Spanish-based IMP Licenced manufacturing subsidiary, Midatech Biogune SA, will be able to provide clinical- grade material for these studies.

Midatech’s aim is to provide innovative solutions for the delivery and stabilisation of bioactive peptides for therapeutic indications and peptide antigens for prophylactic and therapeutic vaccines.

Midatech has a collaboration with MonoSol Rx, Warren, NJ (USA) to develop products by combining its proprietary gold-nanoparticle technology with MonoSol’s PharmFilm® drug delivery technology and a Joint Venture with Immunotope in Doylestown, PA (USA) to develop nanoparticle based immunotherapeutic cancer vaccines for the delivery of peptide antigens.

The post Midatech receives Regulatory Approval for Clinically Testing Ultra- small Gold Nanoparticles appeared first on Midatech.

Midatech Biogune S. L., the nanoparticle manufacturing subsidiary of the Midatech Group, a global leader and centre of excellence for the design, development, synthesis and manufacture of nanomedicines, is pleased to announce that it has been granted an Investigational Medicinal Products (IMP) License from the Spanish Medicines Agency for the cGMP manufacture of clinical grade nanoparticles at its state-of-the art facility in Bilbao, Spain.

Inspectors from the Spanish Medicines Agency carried out an inspection of the Midatech Biogune facility on the 15th and 16th of February 2011 and thereupon granted the accreditation, making Midatech one of the first companies in Spain to be granted this type of license under the new European regulations.

Justin Barry, CEO, said; “Getting such a rapid and positive response from the Medicines Agency validates the quality of our manufacturing and endorses the investment that Midatech has made into its first class quality systems.”

Tom Rademacher CEO and Chairman of the Midatech Group, added; “This is great news for colleagues in Spain, and for Midatech globally. It marks a critical stage in the Company’s history in our development as a clinical stage company, with our novel insulin formulation approaching first-in-man trials.”

The post Midatech Receives Manufacturing License in Spain for its Nanoparticles appeared first on Midatech.

Efforts Underway for Human Trials in 2011

MonoSol Rx, the developer of PharmFilm® drug delivery technology, and Midatech Group Ltd., a global leader and centre of excellence for the design, development, synthesis and manufacture of nanomedicines, today announced positive results from a pre-clinical study of insulin PharmFilm, the first-ever oral insulin film formulation to transbuccally deliver an active therapeutic dose of insulin in a diet- induced diabetic primate model.

The post MonoSol Rx and Midatech Ltd Complete Transbuccal Insulin Delivery Study in Primate Diabetes Model appeared first on Midatech.

The post MonoSol Rx and Midatech to Develop Insulin in PharmFilm®; To Establish Joint Venture appeared first on Midatech.

The post Filing of Joint Patent Application for Nanoparticle Film Delivery Systems appeared first on Midatech.