Pantec Biosolutions Achieves Clinical Efficacy POC for Delivery of urinary FSH using P.L.E.A.S.E.^®

Ruggell, Liechtenstein, 15 December 2010- Pantec Biosolutions AG, a privately-owned company developing innovative transdermal drug delivery products, today announced that a FSH (follicle stimulating hormone of 32 kDa) patch used in conjunction with the Company’s novel P.L.E.A.S.E.^® (Precise Laser Epidermal System) technology has successfully achieved proof of concept in an exploratory clinical trial.

The purpose of the study was to investigate the primary pharmacodynamic characteristics as well as the safety and tolerability of the newly developed FSH protein patch in 10 oocyte donors and to compare them with the effects of subcutaneous injections of Fostimon^® (native urinary FSH) in another 10 oocyte donors. The donors were randomly assigned to the two groups. The end of study was the successful collection of at least two follicles of 15-27 mm diameter after the FSH stimulation protocol. Principal investigators were Dr. Petr Uher (IVF Centers Prof Zech, Pilsen, Czech Republic) and Prof. Dr. Herbert Zech, (IVF Centers Prof. Zech, Bregenz, Austria).

Due to its size of 32 kDa and physicochemical properties, the urinary FSH hormone cannot permeate intact skin. Therefore, prior to patch application, the skin was microporated using Pantec Biosolutions’ P.L.E.A.S.E.^® laser device in order to create tiny openings in the skin’s outermost layer. These micropores allow FSH transport through the skin and its entry into the systemic circulation. Results showed that six out of ten oocyte donors using the FSH patch/P.L.E.A.S.E. microporation stimulation protocol achieved follicle growth.

These results were compared to a group using subcutaneous injections (Fostimon^®), in which eight donors experienced successful stimulation. At least two follicles of 15-27 mm diameter were retrieved in six out of ten patch/ P.L.E.A.S.E. patients and nine out of ten injection patients. One injection patient dropped out.

Interestingly, despite the trend of more growth of larger follicles with classical FSH treatment (s.c./i.m), the detailed follicle recruitment analysis suggests new follicle recruitment following P.L.E.A.S.E. microporation with differences in follicle quality, implying a potential use of P.L.E.A.S.E. microporation with low-responders.

“These successful proof-of-concept results for our P.L.E.A.S.E.^®-FSH patch represent a key milestone in transdermal delivery,” said Christof Boehler, CEO of Pantec Biosolutions. “Now that we know for sure that this innovative way of delivering FSH works, we are thrilled to proof the implications of this exploratory POC study in regulatory trials, in order to provide all women with a more comfortable and less invasive IVF procedure and low-responders with new hope.” Pantec plans to immediately initiate Phase IIb trial(s) after patch and pore density optimization.

About Pantec Biosolutions and P.L.E.A.S.E.^®

Pantec Biosolutions AG is a private drug delivery company specialised in using laser microporation technology to deliver large molecular weight drugs into the epidermis for local or systemic uptake. Its proprietary P.L.E.A.S.E.^® (Painless Laser Epidermal System) platform enables efficient, needle-free and painless administration of biopharmaceutical drugs, in varying and individualised dosages, through partnered patch technology. The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of US$1.5 – 2 billion.

Pantec Biosolutions’ P.L.E.A.S.E.^® platform is available both for the development of the Company’s own pipeline and for penetration into new markets through strategic partnerships. Pantec Biosolutions is based in Ruggell, Liechtenstein.

For further details please contact:

At the Company Pantec Biosolutions AG
Dr. Christof Boehler, Chief Executive Officer
Tel: +423 377 1390
Email: info@pantec-biosolutions.com 

Media Relations College Hill Life Sciences
Douglas Pretsell, Account Director 
Tel: +49 (0)89 57 00 18 06 
Email: douglas.pretsell@collegehill.com