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Product Pipeline

Anti-HER2 Immunoliposomal Doxorubicin combines the long circulating properties of pegylated liposomal doxorubicin (Doxil®) with the target specificity of an anti-HER2 scFv antibody fragment for immunotargeting. This product has been exclusively licensed, and is in joint development with Alza/Johnson & Johnson. The targeted drug shows extended pharmacokinetics that are similar to Doxil, cellular uptake in Her2-overexpressing cells, and HER2-specific antitumor activity in multiple tumor models. 


Nanoliposomal Irinotecan utilizes HERMES Nanoliposome technology to stabilize the camptothecin prodrug irinotecan (CPT-11) inside liposomes while in the circulation.  The drug is thought to be delivered to solid tumors and activated locally by tumor-residing macrophages.  Nanoliposomal Irinotecan has been shown to have long circulation lifetimes, low toxicity, and a high degree of antitumor efficacy in a wide range of animal tumor models, including breast cancer, colon cancer, gliomas, pancreatic cancer, thyroid cancer, and cervical cancer.  Phase I clinical trials were completed in Taiwan in 2004 through an Asian co-development partner, PharmaEngine. A randomized phase II trial in patients with gastric cancer has been initiated in Europe in 2007.  An IND has been filed for a phase I/II trial in the United States in May of 2007 for patients with Malignant Gliomas using i.v. delivery.   Nanoliposomal Irinotecan has also shown tremendous efficacy when delivered locally to brain tumors using convection-enhanced delivery.

Nanoliposomal Vinorelbine utilizes HERMES Nanoliposome technology to stabilize the vinca alkaloid vinorelbine inside liposomes.  Vinorelbine is currently used in first line nonsmall cell lung cancer and is preferred in elderly patients due to its relatively mild toxicity profile.  Stable encapsulation in liposomes has only been possible recently using HERMES proprietary Lipotrap technology.  The result is a long circulating formulation that results in a significant improvement in antitumor activity in multiple breast and lung tumor models.  Nanoliposomal vinorelbine has recently finished Phase I trials in Taiwan through an Asian partner, Taiwan Liposome Company, and is currently being evaluated in Phase II trials.  HERMES is currently exploring potential partnerships for US,  European, and Japanese Clinical Development of this agent. HERMES is also continuing to evaluate EGFR-immunotargeted liposomal vinorelbine constructs in preclinical models for the treatment of breast and lung cancer as well.

Pipeline

1 Phase I and II trials were initiated in Taiwan with partner (PharmaEngine).  A Phase I/II trial in patients with malignant gliomas is planned for 2007.

2 Phase I and II trials were initiated in Taiwan with partner (Taiwan Liposome Company)


Emerging Pipeline
1. Nanoliposomal forms stably encapsulating modern pharmaceuticals from the classes of taxanes, HDAC inhibitors, hsp90 inhibitors, and camptothecins using LipoTrap™ liposome drug trapping and stabilization technology. Stable nanoliposomal encapsulation allows sustained levels of these agents to be achieved with preferential accumulation in the site of disease, such as cancer or inflammation, and creates a nanocarrier-encapsulated drug module for ligand-targeted delivery into diseased cells.

2. Novel scFv  and other antibody-based targeting ligands for immunotargeted liposomal delivery of anticancer agents based on new prostate cancer markers, EGFR, and VEGFR. Novel targeting epitopes and ligands (a targeting module) allow us to expand the clinical application base of the HERMES's drug and gene nanocarrier formulations.

3.  Highly active and target cell-specific lipid-based nonviral nanocarriers for the delivery of therapeutic nucleic acids, such as anti-telomerase constructs (in collaboration with Dr. Elizabeth Blackburn, UCSF) for treatment of cancer.   Development of Genosphere™ Technology aims at meeting an unmet industrial need for an efficient, scalable, systemically deliverable, non-immunogenic, and targetable  non-viral nanocarrier for nucleic acid therapeutics, equally effective for established gene medicines (such as expressible plasmids, antisense oligonucleotides), and for newly emerging ones (such as siRNA).

4. Methods and compositions for stable and versatile labeling and quantification of the liposomal drug delivery to target tissues in vivo. Radioisotope (SPECT) and infrared optical labeling agents with “plug-in” capability into pre-formulated liposomal therapeutics are developed at HERMES as part of the “individualized medicine” approach. These agents will help physicians to monitor and measure the drug delivery to sites of disease in a patient’s body, to adjust and “tailor” the treatments to each individual patient for maximum efficiency and reduced side effects.   

last updated: July 16, 2007

 
 

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