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Protox announces manufacturing agreement w/ Dompé for PRX321


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Protox announces manufacturing agreement with Dompé for PRX321

VANCOUVER, July 17 /CNW/ - Protox Therapeutics Inc. (TSX-V:PRX) announced

today that it has entered into an agreement with Dompé pha.r.ma S.p.A. (Dompé)

for clinical manufacture and commercial supply of PRX321, its lead product

candidate in development for the treatment of primary brain cancer. Under the

terms of the agreement, Dompé will manufacture PRX321 according to current

Good Manufacturing Practice at its state-of-the-art facility in Italy for the

upcoming pre-pivotal clinical trial and has committed to supply commercial

batches for a period of 5 years following product registration. Terms of the

final agreement have not been released.

"After assessing a number of potential contract manufacturers, we are

pleased to have secured a long-term strategic relationship with Dompé and look

forward to working with them as we continue to advance PRX321 through the

regulatory channels towards commercialization," said Dr. Fahar Merchant,

President and Chief Executive Officer of Protox.

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. PRX321 has also

been studied in a completed Phase 1 trial in which patients with recurrent,

unresponsive metastatic renal cell and non-small cell lung carcinomas were

treated. In addition, 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.

About Dompé

Dompé pha.r.ma operates a state-of-the-art research and manufacturing

centre at L'Aquila, Italy, with advanced research laboratories and

internationally validated production and biotechnology facilities. The

company, supported by 100 research and development scientists, is committed to

the discovery and clinical development of innovative drugs, mainly focused in

the areas of immunology and oncology. The most advanced programs are based on

a novel class of non-competitive allosteric modulators of the chemokine

receptors CXCR1 and CXCR2. Reparixin, the first candidate drug selected from

these programs, is currently undergoing Phase II clinical studies for the

prevention of reperfusion-induced organ damage in kidney and lung

transplantation. Dompé pha.r.ma is a part of the Dompé Group, one of the main

Italian pharmaceutical and biotechnology companies, with products in more than

50 countries and a wide network of dealerships and distributors around the

world. The Dompé Group employs approximately 800 people and has consolidated

sales of approximately 300 million Euro.

About Protox

Protox Therapeutics is a leader in advancing novel, targeted protein

toxin therapeutics for the treatment of cancer and other proliferative

diseases. The company currently has four programs in clinical development

based on two distinct but complementary platforms, INxin and PORxin. A

Phase 2a clinical trial evaluating PRX321 (INxin) for the treatment of primary

brain cancer has been completed and the product candidate has received Fast

Track Designation and Orphan Drug Status from the US FDA. In addition, a

Phase 1 clinical trial evaluating PRX321 for the treatment of patients with

renal cell carcinoma and non-small cell lung cancer has been completed.

Patient enrollment has been completed for a Phase 1 clinical trial evaluating

PRX302 (PORxin) for the treatment of localized prostate cancer. A Phase 1

clinical trial evaluating PRX302 for the treatment of benign prostatic

hyperplasia (enlarged prostate) is ongoing.

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