LOS ANGELES--(BUSINESS WIRE)--Canopus BioPharma, Inc. (OTC: CBIA), a biotechnology company developing pharmaceutical products and assay methods for patients suffering from infectious disease, radiation sickness, cancer, and addiction, announced today the commencement of a 30 patient Phase II clinical trial for its new HIV-1 anti-viral therapy, SpirH™. SpirH™ is being studied to determine its potential to delay the onset of full-blown AIDS when used as a mono-therapy in early stage infection.
The cellular mechanism of SpirH™ is based upon the scientific finding, in the late 1990’s, that the HIV-1 virus behaves like proteins generated by the human fetus, which sends signals to the mother to lower her immune system and allow successful gestation. In a similar manner the HIV-1 virus sends a signal to the immune system of the infected patient to make his/her body lower their immune response and allow the HIV-1 virus to multiply. SpirH™ intercepts this HIV signaling system and allows the immune system to inhibit the HIV viral spread. Canopus BioPharma’s research to date shows that SpirH™ is effective against all strains of the HIV-1 virus, including strains from Africa, Thailand, Brazil and the United States.
Dr. Ezio Baraldi of the AIDS Treatment Centre in Pretoria, South Africa has been selected as the Principal Investigator. He intends to confirm through the SpirH™ clinical trial that this drug is effective in delaying the onset of full blown AIDS. “As a single drug treatment, SpirH™ may offer a significant advantage to early stage HIV patients in preserving their healthy immune status,” said Dr. Baraldi.
The clinical trial has already received approval from the Medicines Control Council of South Africa, where the initial studies will be undertaken. As a mono-therapy in the very early stages of infection, Canopus BioPharma’s South African studies are intended to confirm that SpirH™ will significantly prevent and delay disease progression for HIV+ patients that have not been treated previously. It offers the patient and physician a new therapeutic approach to inhibiting the HIV virus and halting the decline of the immune system, utilizing a drug family with over 30 years of patient administration history.
The active ingredient in SpirH™ is a unique formulation of a prescription medication currently available. SpirH™ will be administered to patients both as a mono-therapy and in association with conventional antivirals to augment their effectiveness.
To achieve its goal of confirming efficacy, Canopus BioPharma also announced today that it is offering SpirH™ supplies and study protocol design to clinics around the world, allowing them to take part in studies using SpirH™. Patrick T. Prendergast, Chairman and Chief Executive Officer of Canopus BioPharma, is encouraged by the worldwide response to testing this drug candidate’s potential.
“A dynamic new approach to the treatment of HIV infection continues its journey towards human approval with the commencement of our Phase II study for SpirH™. We welcome the involvement of other healthcare professionals and patient NGO care groups to help accelerate the scientific investigation of the potential of SpirH™ in early stage HIV+ patient studies,” commented Mr. Prendergast.
According to the World Health Organization, an estimated 40 million people worldwide are infected with the HIV virus. AIDS, the most advanced stage of HIV infection, is the cause of some 20 million deaths since 1981 when HIV/AIDS was first described. Last year 2.9 million people died of AIDS-related illnesses.
About Canopus BioPharma, Inc.:
Canopus BioPharma, Inc. (OTCBB: CBIA) is dedicated to providing the safest, most cost effective and efficacious pharmaceutical products and assay methods to patients suffering from infectious disease, bio-terrorism, cancer, and addiction. With innovative science, proven research and development leadership, and superior products and compounds, Canopus BioPharma has since 2001 been committed to becoming a market trend setter in the new era of healthcare, which is focused on providing affordable therapeutic and diagnostic benefits and pharmaceutical excellence to patients and healthcare professionals worldwide. In addition, the Company is a world leader in the development of novel camelid antibody products to provide unique avenues of progress and improvement in assay methods and monitoring capabilities for physicians, patients and researchers, particularly for food chain protection applications. Canopus maintains staff in Australia, South Africa, Ireland, Panama and the USA. Additional information on the Company is available at www.canopusbiopharma.com.
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. In particular, the Company may not be successful in its efforts commercialize or attain acceptable clinical results for its products. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts and research and development programs, uncertainties as a result of research and development, consumer and industry acceptance, litigation and/or court proceedings, regulatory risks including approval of Food and Drug Administration filings, the ability to achieve and maintain revenues and profitability in the Company’s business lines, and other factors discussed in the Company's filings with the Securities and Exchange Commission.