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Ortho Biotech Oncology Research & Development Unites Johnson & Johnson Biopharmaceutical Oncology R&D Assets

Saturday, April 12, 2008 General News J E 4
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SAN DIEGO, California, April 11

- Newly Established Organization Presents Data on Advancing Compounds atAACR -

Ortho Biotech Oncology Research & Development (ORD), a unit of Johnson &Johnson Pharmaceutical Research & Development, L.L.C., will announce resultsfrom studies of three innovative compounds--Hdm2, c-Met, and HDAC inhibitors--here at the American Association for Cancer Research (AACR) 2008 AnnualMeeting.

"ORD is a new research and development organization that unites thebiotechnology and pharmaceutical oncology efforts of several Johnson &Johnson companies with the goal of transforming cancer into a chronic orcurable disease," said William Hait, M.D., Senior Vice President andWorldwide Head of Ortho Biotech Oncology Research & Development. "The neworganization harnesses broad, multi-disciplinary capabilities and expertisein order to prioritize existing and emerging opportunities, align cancertreatment with modern cancer biology and improve patients' lives."

ORD's scientific approach to cancer examines the cancer cell and thesurrounding tissue, or microenvironment. Previously, researchers oftenstudied cancer as collections of malignant cells growing in isolation, butnow understand cancer cells depend on interactions with the surroundingtissue to survive, grow and metastasize. ORD seeks to identify compoundswhich can inhibit or block the interaction cancer cells have with thesurrounding tissues, which compromises the cancer's ability to survive.

The organization will combine the microenvironment disruptive agents(MDAs) resulting from this approach with classic treatments that directlytarget cancer cells. MDAs represent one of the most promising areas of drugdiscovery, and ORD has a pipeline of several investigational MDAs, includingsome of which are first-in-class and first-in-clinic.

Pre-clinical data presented at this year's AACR meeting demonstrateevidence of broad-spectrum, anti-tumor activity for three new compounds.These compounds selectively target specific pathways and influence theinteraction between cancer cells and the microenvironment to induce cancercell death. The presentations include:

- JNJ-26854165, a first-in-class, first-in-clinic Hdm2 inhibitor whichinduces apoptosis (programmed cell death) in a number of cancer cell lines,and restores function of the p53 tumor suppressor protein through a novelmechanism of action; the compound is in phase I studies for non-small celllung cancer and prostate cancer. (Oral abstract #1592)

- JNJ-26481585, a novel, second-generation pan-Histone Deacetylase (HDAC)inhibitor with anti-tumor activity against solid and hematologicalmalignancies, which interferes with expression of genes that control cancercell proliferation, angiogenesis and metastasis; phase I trials are ongoing.(Oral abstract #2444)

- JNJ-38877605, a small molecule that selectively and potently inhibitsthe c-Met receptor tyrosine kinase (c-Met RTK) pathway that regulatesinhibition of signaling from the microenvironment to block cancer celldevelopment and metastasis; based on promising pre-clinical properties andclean toxicity profile of JNJ-38877605, ORD has advanced this potent anduniquely selective c-Met inhibitor into clinical evaluation in multiplemetastasized malignancies. (Poster abstract #4837)

"These new agents are just a few of the novel compounds from our pipelinethat we hope may lead to the control of cancer," Dr. Hait said. "Thescientific community is attempting to identify all the genetic abnormalitieswithin cancer cells; this has yielded a finite number of treatmentopportunities. The scientific approach of ORD has the potential to generatenew opportunities to improve cancer care."

About Our Compound Targets

Human Double Minute 2 (Hdm2)

The Hdm2 oncogene is activated in cancers through various mechanisms,including gene
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