Nanotechnology Now

Our NanoNews Digest Sponsors
Heifer International



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 (Campto® or Camptosar®) 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

Virginia Tech physicists propose path to faster, more flexible robots: Virginia Tech physicists revealed a microscopic phenomenon that could greatly improve the performance of soft devices, such as agile flexible robots or microscopic capsules for drug delivery May 17th, 2024

Gene therapy relieves back pain, repairs damaged disc in mice: Study suggests nanocarriers loaded with DNA could replace opioids May 17th, 2024

Shedding light on perovskite hydrides using a new deposition technique: Researchers develop a methodology to grow single-crystal perovskite hydrides, enabling accurate hydride conductivity measurements May 17th, 2024

Oscillating paramagnetic Meissner effect and Berezinskii-Kosterlitz-Thouless transition in cuprate superconductor May 17th, 2024

Govt.-Legislation/Regulation/Funding/Policy

International research team uses wavefunction matching to solve quantum many-body problems: New approach makes calculations with realistic interactions possible May 17th, 2024

Aston University researcher receives £1 million grant to revolutionize miniature optical devices May 17th, 2024

NRL charters Navy’s quantum inertial navigation path to reduce drift April 5th, 2024

Discovery points path to flash-like memory for storing qubits: Rice find could hasten development of nonvolatile quantum memory April 5th, 2024

Nanomedicine

Virginia Tech physicists propose path to faster, more flexible robots: Virginia Tech physicists revealed a microscopic phenomenon that could greatly improve the performance of soft devices, such as agile flexible robots or microscopic capsules for drug delivery May 17th, 2024

Diamond glitter: A play of colors with artificial DNA crystals May 17th, 2024

Advances in priming B cell immunity against HIV pave the way to future HIV vaccines, shows quartet of new studies May 17th, 2024

New micromaterial releases nanoparticles that selectively destroy cancer cells April 5th, 2024

Announcements

Virginia Tech physicists propose path to faster, more flexible robots: Virginia Tech physicists revealed a microscopic phenomenon that could greatly improve the performance of soft devices, such as agile flexible robots or microscopic capsules for drug delivery May 17th, 2024

Diamond glitter: A play of colors with artificial DNA crystals May 17th, 2024

Finding quantum order in chaos May 17th, 2024

Oscillating paramagnetic Meissner effect and Berezinskii-Kosterlitz-Thouless transition in cuprate superconductor May 17th, 2024

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




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project