Nanotechnology Now





Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > PharmaEngine Receives Approval of US IND Application for a Phase II Study of PEP02 (Liposome Irinotecan Injection) in Pancreatic Cancer

Abstract:
PharmaEngine, Inc. announced today that it has received approval of an Investigational New Drug (IND) application from the U.S. FDA for PEP02, a liposome formulation of irinotecan in a phase II study in patients with metastatic pancreatic cancer. Previous phase I data showed excellent pharmacokinetics, tolerability and efficacy of PEP02 in advanced solid tumor patients in a poster presented at 2008 ASCO Annual Meeting.

PharmaEngine Receives Approval of US IND Application for a Phase II Study of PEP02 (Liposome Irinotecan Injection) in Pancreatic Cancer

Taipei, Taiwan | Posted on December 3rd, 2008

During the pre-IND meeting this September, the FDA concurred with PharmaEngine's pancreatic cancer study design, as well as the overall development strategy for pancreatic, gastric, and colorectal cancers. Subsequently, the company completed IND submission in October, and received the safe-to-proceed letter in November. "I am very delighted that we have achieved an important milestone of IND approval for our second phase II study," said Grace Yeh, Ph.D., President and Chief Executive Officer. "PharmaEngine is most likely the first Taiwan company which has obtained regulatory approvals for phase II studies in Asia, Europe and the US, based on the phase I data generated in Taiwan."

The phase II study is an open-label, multi-national, optimal 2-stage design to be conducted in the US and Taiwan. PharmaEngine plans to enroll metastatic pancreatic cancer patients who failed gemcitabine containing regimen during 2009. There is no standard second line treatment for this nearly fatal cancer.

About PEP02

PEP02 is irinotecan hydrochloride encapsulated in a liposome formulation. Hermes Biosciences, Inc. (South San Francisco, CA, USA) invented the nanoparticle formulation, and licensed it to PharmaEngine to develop, manufacture, and commercialize in Asia and Europe. Irinotecan (CPT-11) is a topoisomerase I inhibitor which has shown significant activity in a variety of tumor types. The Irinotecan Injection (CamptoŽ or CamptosarŽ) has been approved for the treatment of colorectal cancer with sales of nearly US$1 billion in 2007. However, at high dosage, irinotecan causes severe diarrhea and myelosuppression, which is recognized as the dose-limiting toxicity and limits the use of more aggressive irinotecan therapy.

In the phase I clinical studies in advanced solid tumor patients, PEP02 given as a single agent or in combination with other chemotherapeutic agents showed a better pharmacokinetic, safety and efficacy profile, which compared favorably to the published data of unencapsulated irinotecan, or other types of formulations.

In early 2008, PharmaEngine initiated a multi-national (Europe and Asia), randomized phase II study of PEP02 as a second line treatment in gastric cancer patients. The study is estimated to complete patient enrollment in the first half of 2009.

####

About PharmaEngine, Inc.
PharmaEngine, Inc. is a biopharmaceutical company established in Taipei, Taiwan in 2003, and funded by TTY Biopharm and Taiwan venture capitals for NTD630 million (around US$20 million) in 2004. The company focuses on the development of new drugs to treat cancer and Asian prevalent diseases.

For more information, please click here

Contacts:
Peter Wu
+886(2)-2515-8228
Senior Manager of Business Development
Fax: +886(2)-2515-7558

Copyright © Business Wire 2008

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

Basel physicists develop efficient method of signal transmission from nanocomponents May 23rd, 2015

This Slinky lookalike 'hyperlens' helps us see tiny objects: The photonics advancement could improve early cancer detection, nanoelectronics manufacturing and scientists' ability to observe single molecules May 23rd, 2015

Visualizing How Radiation Bombardment Boosts Superconductivity: Atomic-level flyovers show how impact sites of high-energy ions pin potentially disruptive vortices to keep high-current superconductivity flowing May 23rd, 2015

Conversion of Greenhouse Gases to Syngas in Presence of Nanocatalysts in Iran May 22nd, 2015

Govt.-Legislation/Regulation/Funding/Policy

This Slinky lookalike 'hyperlens' helps us see tiny objects: The photonics advancement could improve early cancer detection, nanoelectronics manufacturing and scientists' ability to observe single molecules May 23rd, 2015

Visualizing How Radiation Bombardment Boosts Superconductivity: Atomic-level flyovers show how impact sites of high-energy ions pin potentially disruptive vortices to keep high-current superconductivity flowing May 23rd, 2015

Nanotherapy effective in mice with multiple myeloma May 21st, 2015

Turn that defect upside down: Twin boundaries in lithium-ion batteries May 21st, 2015

Nanomedicine

New Antibacterial Wound Dressing in Iran Can Display Replacement Time May 22nd, 2015

Researchers develop new way to manufacture nanofibers May 21st, 2015

Effective Nano-Micelles Designed in Iran to Treat Cancer May 20th, 2015

Nature inspires first artificial molecular pump: Simple design mimics pumping mechanism of life-sustaining proteins found in living cells May 19th, 2015

Announcements

Basel physicists develop efficient method of signal transmission from nanocomponents May 23rd, 2015

This Slinky lookalike 'hyperlens' helps us see tiny objects: The photonics advancement could improve early cancer detection, nanoelectronics manufacturing and scientists' ability to observe single molecules May 23rd, 2015

Visualizing How Radiation Bombardment Boosts Superconductivity: Atomic-level flyovers show how impact sites of high-energy ions pin potentially disruptive vortices to keep high-current superconductivity flowing May 23rd, 2015

New Antibacterial Wound Dressing in Iran Can Display Replacement Time May 22nd, 2015

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More










ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project