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Innopharmax Inc. Taiwan flag Taiwan
Abstract ID:
INNOPHARMAX is leveraging the OralPASŪ technology to develop Gemcitabine OralPASŪ, a Phase 2 ready oral gemcitabine program with available data demonstrating \r\nStable disease in 12 patients having either advanced solid malignancies and/or malignant lympho
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Stable disease in 12 patients having either advanced solid malignancies and/or malignant lymphomas, nine (9) of whom were on study for ≥ three (3) months
No dose limiting toxicities (DLTs)
Low incidence of adverse events with the majority being mild-to-moderate (Grade 1 or Grade 2)

Gemcitabine OralPASŪ is protected by a robust intellectual property portfolio with granted patents providing protection for both the program as well as the underlying technology across the seven major markets

GEMCITABINE (2',2'-difluorodeoxycytidine) is a fluorine- substituted deoxycytidine analog with a broad spectrum of antitumor activity. It is rapidly and extensively deaminated by cytidine deaminase to the inactive metabolite, 2',2'-difluorodeoxyuridine (dFdU). In order to enhance the bioavailability as well as the stability of gemcitabine via oral administration, INNOPHARMAX has applied OralPASŪ technique on gemcitabine to prepare unique oral formulation. OralPASŪ enhances the bioavailability of drugs through solubilization in the excipient matrix or interface and dispersion in the gastrointestinal tract. These characteristics result in faster drug release from nanoparticles in a reproducible manner, which can be designed further to make the release characteristics independent of the gastro-intestinal physiology and the fed/fasted state of the patient. Recently, several in-vitro and in-vivo studies (i.e. pilot tests in rats and dogs) have been done and study goals have been met.  

The key advantages of OralPASŪ include, but is not limited to
Applications to both Class III and Class IV drug candidates
Disperses drug-contained droplets into nano-size particles
Increases solubilization and dissolution
Protects against degradation
Enhances oral absorption

OralPASŪ has numerous applications to include reformulating new chemical entities (NCEs) with solubility issues; developing generic drugs with high technology barriers to entry; as well as, reformulating known drugs in an effort to address unmet medical needs and/or increase patient compliance
Type of Business Relationship Sought

To look for partners around the world to license out or co-develop Inno-D07001(Gemcitabine Oral)

Last Updated Oct 2014
Technology Type THERAPEUTIC
Phase of Development CLINICAL TRIALS

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