Genyous Initiatives to Reduce Suffering Due to Prostate Disorders (Prostatitis, BPH, PIN, HGPIN and Cancer)
Genyous Biomed International (“Genyous”) was founded in 2000 by a group of practical visionaries who seek to significantly improve the methods used to address the growing burden that prostate cancer is placing on society. Genyous is committed to developing an affordable and well-tolerated integrated healthcare solution comprised of early detection and diagnostics coupled with Multifunctional Multitargeted (MFMT™) pharmaceuticals (patents pending) representing a new class of drugs intended for prevention, early intervention and treatment of heterogeneous prostate disorders including prostatitis, BPH, PIN, HGPIN and prostate cancer.
Genyous commercializes its products by licensing to spin off companies and pharmaceutical companies that focus on the unique business characteristics of each component of its integrated solution.
Major Challenges in Early Detection and Management of Prostate Cancer:
In North America the mortality rate for prostate cancer has declined since the introduction of the PSA test. However, growing debate has emerged regarding over diagnosis and over treatment of prostate cancer, and increasing correlation between elevated PSA and other prostate disorders such as prostatitis, BPH, PIN & HGPIN—diseases that may manifest separately or simultaneously. These urological disorders affect a significant portion of the male population in the U.S. (prostatitis: 50% lifetime risk, BPH: 50% incidence by age 50, prostate cancer: 50-75% incidence by age 75). Of these prostate disorders only prostate cancer is generally associated with morbidity. However, all of these prostate disorders (and their treatments) are often associated with a significant reduction in quality of life leading to significant economic impact. For example, a study recently published by the Milken Institute estimates that in 2003 U.S. expenditures in treating cancer totaled $48.1 billion, while the economic impact (due largely to lost productivity) was closer to $271 billion.
Another clinical challenge in managing prostate cancer is the absence of a marker differentiating life threatening prostate cancer from less aggressive forms of the disease that do not require severe intervention such as surgical removal of the prostate. Such challenges contribute to over treatment resulting in unnecessary patient suffering and healthcare costs (as well as complications due to treatment). Until an improved early detection solution emerges, less invasive early intervention solutions are in great demand.
Prevention/Early Intervention/Treatment of Prostate Cancer via MFMT Drugs:
Cancer has been described as a heterogeneous disease, a characterization that has been substantiated by the finding that hundreds of genes are implicated in cancer. Modern discoveries have also determined that carcinogenesis is not just a function of cell features, but also of the cell’s interaction with its microenvironment (stroma) and the immune response system. To address this heterogeneous nature of cancer, Genyous has invented Multifunctional Multitargeted (MFMT™) therapies, a new class of drugs (patents pending) formulated based on a systems biology strategy. MFMT drugs have been formulated to deliver multiple synergistic actives in low doses, with a goal of avoiding disruption of homeostasis and minimizing development of drug resistance in patients. Genyous’ MFMT drugs are orally bioavailable, and given their wide dosing window, they are ideal for prevention, early intervention and maintenance (converting cancer to a chronic disease with minimal risk of recurrence). Genyous’ MFMT drugs are designed to mitigate symptoms associated with multiple prostate disorders and to disrupt the progression of prostate cancer.
Early Intervention
Cancer has been characterized as a progression of biological changes spanning many years, rather than a spontaneous random event. Given this, there are many opportunities to disrupt this progression, even after clinically detectable changes have manifested but before cancer has developed. Diseases such as BPH, prostatitis and PIN often occur prior to prostate cancer. Pharmaceuticals that alleviate multiple symptoms associated with prostate disorders (e.g. restricted urine flow, elevated PSA, inflammation, and pain) and disrupt processes associated with prostatic carcinogenesis (such as chronic inflammation), without reducing quality of life, are the ideal early intervention solution for people at high risk of prostate cancer. Genyous’ prevention and early intervention MFMT drug candidates, Thriva™ (VTT201) and VTT301 are formulated to address these needs and are targeted to be commercialized in 2010 by its affiliate, Vitala Therapeutics (http://www.vitaltherapeutics.com).
Cancer Treatment
Genyous’ lead MFMT oncology drug candidate, Aneustat™ (OMN54), has been approved in Canada for a Phase I PK/dose escalation study to be conducted at the British Columbia Cancer Agency (“BCCA”) in Vancouver and at Princess Margaret Hospital in Toronto. Aneustat has been found to possess six therapeutic functions and to act on eight biological targets associated with carcinogenesis. Pre-clinical studies conducted by the BCCA show that Aneustat is orally bioavailable, extends survival of animals harboring human cancer, and inhibits androgen independent prostate cancer xenografts on par with combination chemotherapy but without significant side effects. Additionally, the BCCA has conducted safety studies in rats (including daily dosing for 6 months) which demonstrated that Aneustat generated no toxicities in animals. Pre-clinical studies suggest that Aneustat has the potential for broad use including as an adjuvant to surgery, as an adjuvant to hormone and radiation therapy, and in combination with chemotherapy. Genyous’ oncology products are targeted to be commercialized in 2011 by its affiliate, Omnitura Therapeutics (http://www.omnitura.com).
Genyous Strategic Alliance Program
Genyous is in the process of forming alliances for scientific, clinical and commercial collaboration (which may include financial investment) to accelerate the delivery of these innovative solutions to those suffering from prostate disorders.