HemoBioTech, Inc. Engages CRO to Facilitate Clinical Study in India of Its Human Blood Substitute, HemoTech
DALLAS, June 21 /PRNewswire-FirstCall/ -- HemoBioTech announced today that it has engaged Paragon Biomedical (http://www.parabio.com) to provide regulatory and clinical services in India related to the Company's proposed human blood substitute, HemoTech. Paragon will submit preclinical data regarding HemoTech studies that were part of a European IND and clinical data related to the HemoTech human study in Zaire to the Indian regulatory agency for review. The goal is to receive permission to commence clinical studies of HemoTech in India.
A limited clinical study of HemoTech was performed in 1991 at the Institute de la Recherche en Sciences de la Sante, Centre de l'Anemie S.S. in Zaire. Results of this study were published (Simoni, J., Feola, M., Angelillo, R., Luhruma, Z., Kabakele, M., Manzombi, M., Kaluila, M.: "Clinical Trial of a Hemoglobin-based blood substitute in patients with Sickle Cell Anemia." Surgery, Gynecology & Obstetrics - 174 : 379-386, 1992). Nine sickle cell anemia patients were infused with amounts of HemoTech representing 25 percent of patients' total blood volume. This limited clinical trial resulted in significant patient improvement and suggested that HemoTech: 1) can work as a physiological oxygen carrier in humans; 2) is non-toxic; 3) is vasodilatory and anti-inflammatory; and 4) induces red blood cell production (erythropoiesis). Peripheral blood reticulocytes increased from 4 percent to 49 percent.
"HemoBioTech considers India a key component of our global strategy to commercialize HemoTech," said Arthur P. Bollon, PhD, Chairman and CEO of HemoBioTech. "With a population of 1.1 billion people, a significant middle class, and a good infrastructure for clinical studies, HemoBioTech considers India as a potential standalone market for HemoTech. Therefore, we are very pleased to be working with Paragon as we address the growing global need for a substitute for human blood."
Paragon Biomedical is a US-based contract research organization (CRO) that manages international Phase 1-IV clinical trials. In 2006 Paragon named Balagopal S. Nair, MD, as its Operational Director in India. Dr. Nair has extensive experience managing clinical studies and working with the Indian regulatory agency. The India office is located at the Technopark Campus in Trivandrum. This state-of-the-art facility is India's only CMMI Level 4 accredited technology centre and one of the two largest IT campuses in India today, affording Paragon the opportunity to attract and select the most highly qualified and committed individuals. Paragon's decentralized model allows its clinical team to cover all regions of India in a highly productive and cost-effective manner. Paragon's clinical team has a wide variety of therapeutic experience and has over 15 years of combined experience conducting clinical trials in India.
HemoBioTech is developing what could be the world's first viable substitute for human blood -- HemoTech -- exclusively licensed from Texas Tech University Health Sciences Center. Previous efforts by other companies to develop a human blood substitute during the past 35 years have failed because of toxicity issues. On the other hand, the HemoBioTech strategy has been to identify and nullify the source of toxicity, resulting in HemoTech, which is expected to be compatible with all blood types and have a shelf life of 180+ days compared to 42 days for donated human blood.
HemoTech's apparent lack of toxicity is believed to be due to HemoBioTech's proprietary chemical modification of hemoglobin. HemoBioTech believes the use of bovine blood provides an additional advantage over products developed from outdated human red blood cells or from perfluorochemicals (PFCs), as bovine blood is more readily available and more cost-effective to use. Also, in the limited clinical testing HemoTech did not show the vasoconstriction and inflammatory toxicities that have hampered competitors.
About Paragon Biomedical
Founded in 1989, Paragon Biomedical is a privately held, woman-owned contract research organization (CRO) specializing in the management of global Phase I-IV clinical trials in key therapeutic areas including cardiology, CNS, infectious diseases, and general medicine. Paragon delivers services through its US-based headquarters in Irvine, California, and international offices in the UK, Poland and India. Paragon's unique corporate culture has attracted the industry's top project managers, clinical research associates and executives who share a strong commitment to excellence, and the vision to make a difference through the passionate pursuit of better healthcare. For more information, visit http://www.parabio.com or contact Lisa VanStaaveren at 949-224-2800 or lvanstaaveren@parabio.com.
About HemoBioTech, Inc.
HemoBioTech is engaged in the development of HemoTech, a novel human blood substitute technology exclusively licensed from Texas Tech University Health Sciences Center. HemoTech is composed of bovine hemoglobin that is chemically modified with ATP, adenosine and GSH. HemoTech not only can carry oxygen in the blood, but can also induce erythropoiesis (red blood cell production). The Company believes that HemoTech, due to its novel structure, may possess properties that diminish the intrinsic toxicities which have plagued other attempts at developing blood substitutes, based upon pre-clinical and initial human clinical trials undertaken outside the U.S. by prior holders of this technology. HemoTech is being subjected to further studies and testing to confirm and possibly expand on these results. HemoTech is being developed to help reduce or eliminate the danger resulting from acute blood loss in trauma, as well as for other conditions. Corporate headquarters are located at 5001 Spring Valley Road, Suite 1040-West, Dallas, Texas 75244. For further information contact Dr. Arthur Bollon at 972-455-8950 or abollon@hemobiotech.com. Company website is http://www.hemobiotech.com.
Safe Harbor Statement
Except for historical information, the matters discussed in this news release may be considered "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of HemoBioTech and its management and are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others the successful pre-clinical development, the successful completion of clinical trials, the FDA review process and other governmental regulation, pharmaceutical collaborator interest and ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors which are included in HemoBioTech's Annual Report on Form 10-KSB for the year ended December 31, 2006, as amended, and HemoBioTech's other reports filed with the Securities and Exchange Commission.
Contact: Dr. Arthur Bollon, CEO, HemoBioTech, 972-455-8950
HemoBioTech, Inc.CONTACT: Dr. Arthur Bollon, CEO of HemoBioTech, +1-972-455-8950