Healthcare Industry News: benign prostatic hyperplasia
News Release - November 14, 2007
Protox collaborates with BrainLAB for Brain Cancer ProgramVANCOUVER, Nov. 14 (Healthcare Sales & Marketing Network) - Protox Therapeutics Inc. (TSX-V: PRX ) today announced that it has entered into a collaborative research and clinical development agreement with BrainLAB AG for use of the BrainLAB proprietary drug delivery software iPlan(R) Flow in the planned pre-pivotal primary brain cancer clinical trial of PRX321. Terms of the final agreement have not been released.
As part of the agreement, BrainLAB will supply and install its iPlan Flow software at all clinical sites participating in the pre-pivotal trial. The software will incorporate patient-specific information to monitor and potentially predict drug distribution in and around the brain tumor. Using the iPlan Flow software, neurosurgeons will be able to better plan treatments and optimize catheter placement for ideal delivery and distribution of PRX321.
"We are very pleased to have secured this agreement with BrainLAB and see this as an important step in the commercial development of PRX321 for the treatment of primary and metastatic brain cancer." said Dr. Fahar Merchant, President and Chief Executive Officer of Protox. "The use of this software should allow for patient-specific treatment resulting in optimal delivery and distribution of PRX321 which in turn could lead to more favorable outcomes in patients with this disease."
"With Protox, we have found one of the most experienced teams for targeted drug delivery as a key partner in the development of therapies for brain tumors," said Dr. Christoph Pedain, Director of BrainLAB Pharmaceutical Solutions. "This cooperation provides the possibility to improve delivery of PRX321 to the brain by incorporating promising new BrainLAB technologies. These technologies are designed to ease adoption and improve standardization among participating clinical centers."
In addition to the iPlan Flow software, BrainLAB will also provide hospital support services during this clinical study by installing computer hardware and software at the study sites, provide support and training for the participating neurosurgeons and perform data collection and analysis of study results.
Facts about brain cancer
The American Cancer Society estimates that in 2007 approximately 20,000 people will be diagnosed with brain cancer and 12,500 will die as a result of the disease in the United States. Primary brain cancer is currently treated with an aggressive combination approach that includes surgery, radiation therapy and chemotherapy. Although treatment may prolong survival, most malignant brain tumors are not curable. As such, a significant unmet need exists for this form of cancer.
BrainLAB develops, manufactures and markets software-driven medical technology that enables procedures that are more precise, less invasive, and also less expensive than traditional treatments. Among the core products are image-guided systems that provide highly accurate real-time information used for navigation during surgical procedures. This utility has been further expanded to serve as a computer terminal for physicians to more effectively access and interpret diagnostic scans and other digital medical information for better informed decisions. BrainLAB solutions allow expansion from a single system to operating suites to digitally integrated hospitals covering all subspecialties from neurosurgery, orthopedics, ENT, CMF to spine & trauma and oncology. With more than 2,950 systems installed in over 70 countries, BrainLAB is a market leader in image-guided technology. The privately held BrainLAB group, founded in 1989, is headquartered in Munich, Germany and today employs more than 950 people in 16 offices across Europe, Asia, Australia, North and South America.
For more information, visit BrainLAB at www.brainlab.com
PRX321 is a novel targeted protein 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. PRX321 is in clinical development for the treatment of primary brain cancer, specifically malignant astrocytoma and glioblastoma multiforme (GBM). Results from a Phase 2a clinical trial completed in patients with recurrent and progressive GBM showed potent anti-tumor effects without drug-related systemic toxicity in the majority of patients. Based on encouraging safety and efficacy results from this trial, Protox is preparing to conduct a pre-pivotal clinical trial.
Protox Therapeutics is a leader in advancing novel, targeted protein toxin therapeutics for the treatment of cancer and other proliferative diseases. Two novel drug candidates derived from the company's INxin(TM) and PORxin(TM) platforms are being developed in three clinical programs. A Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary brain cancer has been completed and the drug has received Fast Track Designation and Orphan Drug Status from the US FDA. Phase 1 clinical trials evaluating PRX302 (PORxin) have been completed for the treatment of localized prostate cancer and benign prostatic hyperplasia (enlarged prostate).
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Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on Protox' current beliefs as well as assumptions made by and information currently available to Protox and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Protox in its public securities filings; actual events may differ materially from current expectations. Protox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For further information
James Beesley, Director, Investor Relations, Protox Therapeutics, (604) 688-0199, email@example.com Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241, firstname.lastname@example.org Dr. Christoph Pedain, Director Pharmaceutical Solutions, BrainLAB AG, + 49 89 99 15 68 154, email@example.com
Source: Protox Therapeutics
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