Erik, et. al., NBIX sold a P2 oncology program[IL4+pseudomonas toxin]?..this arrived in my GBM news feed..any thoughts on this program? Rick perhaps?
Protox acquires Phase II cancer program from Neurocrine and U.S. Public Health Service
VANCOUVER, July 20 /CNW/ - Protox(TM) Therapeutics Inc. (TSX-V:PRX) today
announced that it has acquired a Phase II clinical stage program for the
treatment of cancer from Neurocrine Biosciences Inc. and the United States
Public Health Service (PHS). The targeted therapeutic toxin PRX321, formerly
known as NBI-3001, has received both Fast Track Designation and Orphan Drug
Status from the U.S. Food and Drug Administration (FDA) for primary brain
tumors. Fast Track Designation enables expedited review by the FDA of products
that are in clinical development and Orphan Drug Status provides a number of
benefits including seven years of market exclusivity.
"We have substantially expanded our clinical pipeline with the
acquisition of PRX321 and view this transaction as accelerating our path
toward becoming the world leader in the development of targeted toxin
therapeutics", said Dr. Fahar Merchant, President and Chief Executive Officer
of Protox. "This transaction transforms Protox into a company with a robust
clinical pipeline targeting serious indications such as brain, kidney,
prostate and lung cancers that have large unmet medical needs. Furthermore,
the acquisition of PRX321 provides us with encouraging human clinical data
from 86 cancer patients, a strengthened intellectual property portfolio of 14
patents issued worldwide and a technology which is supported by over 50
peer-reviewed scientific publications."
PRX321 is a targeted therapeutic toxin in which a cytokine, interleukin-4
(IL-4), is linked to a Pseudomonas exotoxin, a potent substance that can
destroy cancer cells. The IL-4 portion of the compound binds to IL-4 receptors
found on the surface of various types of cancer cells. The drug subsequently
enters the target cell where the toxin component causes cell death by
inhibiting protein synthesis. Besides brain, kidney and lung cancer, PRX321
has shown promising pre-clinical results in a number of cancers
over-expressing IL-4 receptors including pancreatic, ovarian, breast, head and
neck, melanoma, prostate and blood cancers such as chronic lymphocytic
leukemia (CLL) and Hodgkin's lymphoma.
In Phase I and II clinical trials for the treatment of primary brain
cancers, namely, glioblastoma multiforme (GBM) and anaplastic astrocytoma,
patients were administered PRX321 intra-tumorally. Results from these studies
demonstrated potent anti-tumor effects without drug-related systemic toxicity
in the majority of patients. Protox plans to conduct a Phase II dose-refining
clinical trial to optimize the dose for PRX321 in patients with primary brain
cancer. In another Phase I study, patients with recurrent or unresponsive
metastatic renal cell and non-small cell lung carcinomas were administered
escalating doses of PRX321 intravenously to determine the maximum tolerated
dose. Based on the results of this study, Protox plans to continue evaluation
of PRX321 in additional clinical trials for cancers that over-express IL-4
receptors, such as pancreatic cancer.
The PRX321 program was acquired by Protox in two separate transactions.
In the first transaction, Protox obtained exclusive worldwide rights to IL-4
fusion toxin technology (INxin(TM)) from PHS. In the second transaction,
regulatory and product assets were purchased from Neurocrine in order to
facilitate the continued development of PRX321. The assets purchased from
Neurocrine included two Investigational New Drug applications, Fast Track
Designation and Orphan Drug Status, as well as cGMP batches of PRX321 that may
potentially be used in future clinical trials. The IL-4 fusion toxin was
originally discovered and developed by Dr. Raj Puri, from the Center for
Biologics Evaluation and Research of the FDA and colleagues from the National
Cancer Institute (NCI). Subsequent development and clinical studies were
sponsored by Neurocrine and additional research continues at the FDA and NCI
under the direction of Dr. Puri.
Protox has committed to pay PHS and Neurocrine, for the license and
corresponding assets, up to US$2 million over the next three years. In
addition, Protox will pay PHS up to US$4 million in future milestone payments
(based on the compound receiving FDA approval for at least three indications),
as well as royalties on commercial sales. |
