Protox Acquires Phase II Cancer Program from Neurocrine and U.S. Public Health Service
Vancouver, British Columbia, July 20, 2006 – ProtoxTM 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 (INxinTM) 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.
Conference Call
Protox will hold a conference call and webcast to discuss this announcement on July 20 at 4:30p.m. ET (1:30 p.m. PT).
To access the conference call, dial 416-644-3414 or 1-800-814-4861, or access the webcast online.
Please connect approximately ten minutes prior to the beginning of the call to ensure participation. The conference call will be archived for replay and can be accessed by dialing 416-640-1917 or 1-877-289-8525 and enter the reservation number 21197019 followed by the number sign, or via the company’s website.
About Brain Cancers
Malignant gliomas such as GBM and anaplastic astrocytoma account for around 45% of all primary brain cancers and are a leading cause of death from cancer. The American Cancer Society estimates that in 2006 approximately 18,900 people will be diagnosed with brain cancer and almost 13,000 will die because of the disease. Brain tumors are currently treated by surgical removal, radiation or chemotherapy. Although treatment may prolong survival somewhat, most malignant brain tumors are not curable. As such, a significant unmet need exists for a minimally-invasive curative solution. IL-4 receptors are expressed on the surface of malignant tumor cells but not on normal brain cells. IL-4 fusion toxin has a very high affinity for IL-4 receptors and binds tightly to IL-4 receptors on the surface of these tumor cells. The toxin portion of the molecule is then selectively delivered into the tumor cells, destroying the tumor while sparing healthy surrounding cells.
About Protox
Protox Therapeutics is a product-focused development-stage company and a leader in advancing novel, targeted protein toxin therapeutics for treatment of cancer and other proliferative diseases. The company currently has three clinical programs in various stages of development for the treatment of primary brain cancers, localized prostate cancer and cancers that over-express IL-4 receptors. The company also has a pre-clinical program for benign prostatic hyperplasia (BPH) that is expected to enter clinical trials. Through the company’s INxin and PORxinTM technology platforms, therapeutic candidates are generated by engineering the naturally occurring toxins, Pseudomonas exotoxin and proaerolysin. These drugs are potent anti-cancer agents with distinct modes of action. INxinTM drugs target cancer cells that produce specific tumor associated receptors on their cell surface. Once bound to the cancer cells, INxin drugs enter the cell and inhibit protein synthesis which ultimately leads to cell death. PORxin drugs are pro-drugs that are activated by specific proteases produced at elevated levels by target cells. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.
NO REGULATORY AUTHORITY HAS APPROVED OR DISAPPROVED THE CONTENT OF THIS RELEASE. THE TSX VENTURE EXCHANGE DOES NOT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
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 contact:
Dr. Shafique Fidai
Senior Director of Corporate Development
Protox Therapeutics
604-608-4222
sfidai@protoxtherapeutics.com
Michael Moore
Investor Relations
The Equicom Group
416-815-0700 x 241
mmoore@equicomgroup.com
