Company Overview

Procyon Biopharma is a publicly-traded Canadian biotechnology company actively engaged in the discovery and development of innovative therapeutics and diagnostics in the fields of oncology and infectious diseases. The mission of the Company is to identify leading-edge technologies, bring them quickly to advanced human clinical trials and license them to pharmaceutical companies for further development and commercialization. Procyon receives from licensee partners upfront and milestone payments, as well as royalty revenues upon commercialization.

Company Information

Additional Details

Legal Name: Procyon BioPharma Inc.

Number of Employees: 37

Contacts

Products

• Ansa - - Antinucleosome Antibodies

  ANTI-NUCLEOSOME ANTIBODIES (ANsA) While the market for chemotherapy and adjunctive products such as immunomodulators continues to grow, there is continued concern with side-effects and toxicity. As a result there has been a resurgence of interest in immunological therapies, particularly monoclonal antibody based therapeutics. ANsA-based therapeutic antibodies specifically target cancer cells by binding to nucleosomes (DNA combined with histone protein), which are usually found within the cell nucleus and out of reach of circulating antibodies. However, during the process of tumor growth, some cancer cells die due to apoptosis. The dying cells release nucleosomes that attach to binding sites on the surface of surviving cancer cells. ANsA antibodies target cancer in this manner and signal the bodys own immune system to break down and kill the cancer cells. Therefore, ANsA may have therapeutics and imagery application.

• Colopath
• Fibrostat

  Fibrostat Fibrostat is the only topical therapeutic cream that reduces excessive scarring following surgery and burns.

  This late stage product in development at Procyon is indicated for the management and prevention of excessive scar formation (hypertrophic scarring) following dermal insult (surgery, grafting, trauma, burns, etc.)

  Hypertrophic scars are characterized by being thick and ropey;

  red, firm and elevated, painful and itchy and can cause functional deficits when they occur across a joint.

  In the wound healing process, the enzyme tissue transglutaminase (tTGase) plays a role in the production of ε- (γ-glutamyl) lysine cross-links to form insoluble collagen matrices. In hypertrophic scarring this enzyme is found to be over-expressed resulting in an over-healing process and an excess deposition of collagen.

  Pre-clinical and clinical evidence suggests that 1, 4 diaminobutane dihydrochloride (1, 4 DAB 2HCl), the active pharmaceutical ingredient of Fibrostat, inhibits tTGase activity.

  The incidence of hypertrophic scarring following surgery is high: 39% in Caucasians and 68% in Orientals, and 33% and 91% in Caucasians and Orientals respectively after burns. Up to 15% of the general population is affected by hypertrophic scarring following wounding (as high as 90% in darker skinned people).

  Currently there are no topical pharmaceutical preparations with an active pharmaceutical ingredient that prevent and/or treat hypertrophic scars. The regulation of collagen production by Fibrostat offers a unique and exciting approach.

  Phase IIb clinical trial is underway to further evaluate the safety and efficacy of 0.8% Fibrostat.

  The rights to Fibrostat for North America are licensed to Biovail Corporation.

• Pck3145 Therapeutic Petide

  PCK3145 PCK3145 is a non-toxic therapeutic for the treatment of prostate cancer.

  PSP94 is a naturally occurring protein synthesized primarily in the prostate and found in large quantities in the seminal fluid. Although the complete physiological role of PSP94 is not completely known, it is believed to be involved as a growth inhibitor and a promoter of cell death in the natural control of excessive and/or abnormal proliferation of epithelial cells both in normal prostate tissue as well as in malignant prostate tissues.

  Studies to date have indicated that PSP94 will induce apoptosis in prostate cancer cells and the clinical utility of these observations are currently under investigation.

  PCK3145 is a synthetic 15-mer peptide based on the sequence of the native PSP94.

  PCK3145 is Procyons lead candidate under investigation for the treatment of HRPC.

  Currently no effective treatments exist for patients where hormone treatment has failed. The management of hormone refractory prostate cancer is solely palliative to date.

  Pre-clinical studies showed that both PSP94 and PCK3145 can act as tumor suppressive agents capable of arresting and inhibiting growth of HRPC by as much as 50%.

  Toxicology and pharmacokinetic study results determined PCK3145 to have no obvious non-specific safety liabilities.

  Phase IIa human clinical trial is underway to confirm the safety and tolerability of PCK3145 in the treatment of patients with metastatic HRPC. Procyon is optimistic about the outcome of this trial and expects a potential fast track approach to commercialization.

• Pl-100 Protease Inhibitor

  PL-100 PL-100 is a next-generation protease inhibitor for the treatment of drug-resistant HIV/AIDS.

  The protease enzyme is a protein that cuts other proteins at highly specific locations. The HIV protease enzyme cleaves polyproteins of the virus into essential functional protein products during the maturation process of the virion. This critical process occurs as each new virion buds from the membrane of an HIV-infected cell and continues after the immature virus is released from the cell. If the cleavage of HIV polyproteins is blocked by an inhibitor, the virus fails to mature and is incapable of infecting a new cell.

  Protease inhibitors are extremely powerful antiviral agents and are a key component of the polytherapy that is commonly used to treat HIV/AIDS. However, they are associated with complex dosage schedules, viral resistance, a multitude of potentially harmful drug interactions and serious side effects such as abnormal fat deposit, diabetes and coronary heart disease.

  Procyon's PL-100 is a second-generation protease inhibitor that demonstrates a unique resistance profile on drug- and multi- drug resistant strains of the HIV virus. Procyon's novel protease inhibitor (PI) technology is based on the use of simple, original molecular scaffolds on which chemical groups are attached in a few easy steps to generate powerful protease inhibitors. Therefore, our competitive advantage is both medical in targeting the unmet medical need of viral resistance and economical in terms of cost-of-goods.

  75% of HIV patients on drug therapy are experiencing drug or multi-drug resistance and 10-20% of the newly diagnosed patients are now presenting resistance. Procyon's PL-100 is a second-generation protease inhibitor compound that shows a competitive advantage over the currently available anti- protease drugs as it is designed to address multi-drug resistance.

  PL-100 pre-clinical studies, including pharmacokinetic, genotoxicity and other safety studies, are being conducted during 2003-2004. Chemistry and manufacturing studies are being conducted in parallel to ensure availability of drug product for clinical testing. PL-100 has been shown to be orally bioavailable with an acceptable half-life.

• Pl-2500 Integrase Inhibitor

  PL-2500 PL-2500 is an integrase inhibitor that addresses a novel mechanism of action for the treatment of HIV/AIDS.

  The integrase enzyme is a complex protein that inserts HIV genetic material into the human DNA. It is responsible for trimming the pro-viral DNA, cutting the host DNA and inserting the pro-viral DNA into the host genome. This process is necessary for viral infectivity and replication. If the insertion of pro-viral DNA into the host genome is prevented by an integrase inhibitor, then the virus can not replicate.

  Procyon's PL-2500 is the lead molecule of a new class of compounds that addresses a novel target the HIV virus. Integrase plays a critical role in the replication cycle of HIV as it is the enzyme activity that is responsible for integrating HIV DNA into the DNA of a patient; inhibition of this step is expected to reduce the patient's viral load. Procyon's novel integrase inhibitor (II) technology is based on simple, novel small-molecule scaffolds with the concept that subsequent scale-up manufacturing activities are facilitated.

  The integrase enzyme represents a very challenging HIV-native enzyme encoded in the HIV genome and constitutes a promising and exciting new therapeutic target.

  As more viral strains develop resistance to PIs, NRTIs and NNRTIs, other therapeutic options become indispensable. To date, numerous integrase inhibitors have been described but only a few have shown sufficient antiviral activity to be pursued further as therapeutic agents. Thus, with its unique mode of action, a chemical from Procyon's PL-2500 drug class has the potential to become a major breakthrough in HIV/AIDS treatment.

  Lead compound optimization studies are currently underway.

• Psp94 Serum-based Immunoassay

  PSP94 Serum based immunoassay PSP94 Serum based immunoassay is a reliable, quick-and-easy serum test to detect and monitor prostate cancer.

  Research has shown PSP94 to exist in blood in a free and a bound form and that the ratio of bound versus free PSP94 is more effective in predicting the disease course. Studies have also shown that levels of PSP94 are hormone-independent and not affected by androgen or anti-androgen therapy. PSP94 assessments are therefore, also likely to have utility during periods of androgen ablation therapy.

  Monoclonal antibodies that recognize free PSP94, bound PSP94 and the binding protein were developed at Procyon. An immunoassay for measurement of PSP94 levels in serum is currently being refined and validated, which is sufficiently specific, accurate and sensitive to be used in a clinical development program. The PSP94 binding protein was recently purified and identified.

  The development of a sensitive laboratory assay for measurement of levels of this protein in the serum of patients with prostate cancer is ongoing.

  Although the current PSA test is the most widely used test for screening, detection and monitoring of prostate cancer, this test is not, however, of much value in the determination of the stage or the progression of the cancer.

  There continues to be a considerable need for additional serum markers for use in prostate cancer management.

  Proof of concept studies in clinical-correlation studies are being developed.

Additional Information