Benda Pharmacecutical (OTC:BPMA) announced Monday that its SiBiono subsidiary has made significant progress in developing a treatment for HIV and AIDS based on gene therapy. As part of a joint venture with Japanese gene therapy research institute DNAVEC, SiBiono will develop DNAVEC's SeV-Gag vaccine, an anti-AIDS gene therapy treatment patented in both China and the United States.
SeV-Gag is based on the Sendai virus (SeV), a respiratory virus which causes pneumonia in mice but is not harmful to primates, including monkeys and humans. Gag is a gene responsible for making a structural protein that is needed by the HIV virus in creating new virus particles. It is theorized that injecting the SeV-Gag virus into an HIV infected person will enhance their immune response, resulting in a reduction in the viral load and preventing HIV infection from progressing to AIDs.SiBiono is the producer of Gendicine, the world's first commercialized gene therapy drug. Gendicine is approved in China for treatment squamous cell cancers of the head and neck. SiBiono's success in developing Gendicine led to its partnership with DNAVEC.
"We deliberately selected SiBiono as our partner from hundreds of other leading biopharmaceutical firms because of its unparalleled expertise and technological superiority in developing, manufacturing and commercializing gene therapy treatments," said Dr. Mamoru Hasegawa, DNAVEC CEO. "SiBiono's demonstrated clinical success with Gendicine(NYSE:R) is a feat no one else in the world has yet matched, and we firmly believe that the joint venture with SiBiono provides us the best opportunity to realize our dream and bring the SeV-Gag vaccine to market."
The joint venture agreement, signed in May 2007, calls for SiBiono to finish preclinical testing, clinical trials and manufacturing tests of the SeV-Gag in China. The research firm is also responsible for obtaining approvals from the Chinese State Food and Drug Administration [SFDA]. All findings will be copatented by SiBiono and DNAVEC. SiBiono expects the SFDA drug approval process to be completed sometime between 2012 and 2018.
The Wuhan China based Benda Pharmaceutical is a producer of traditional Chinese medicine, pharmaceuticals and gene therapy based agents. In fiscal year 2006 the company reported revenues of US$15.9, and net income of US$2.3 million. Year over year sales grew at a 3% rate and net income declined by 33%. SiBiono reported revenues of US$1.56 million and showed a loss of US$798 thousand, with R&D expenses at 44% of revenues. For the first six months of 2007 sales of Gendicine were US$1.48 million, on track to double over the previous year.According to 2006 study by Tsinghua University, by 2010 it is likely there will be 10 million persons infected with the HIV virus in China. At a current treatment cost of US$1400, this indicates the market for HIV treatments will exceed US$14 billion. The US National Institutes of Health [NIH] reports that to date there have been 47 clinical trials of HIV vaccines for treating HIV infection, with another 111 for prevention of HIV transmission. As of yet no vaccine for HIV has been approved in the US or China.