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BiondVax Proceeds with Multimeric Vaccine after Discontinuing Phase I Clinical Trial, November 12, 2007
The company has announced the successful expression of two versions of its 2nd generation, Multimeric vaccine against influenza. After its purification, the company intends to examine this vaccine in animal models. In the Phase 1 clinical trial of its 1st generation epitope-based vaccine within flagellin, administration of a very low concentration of the influenza epitopes resulted in an immune response specific to the influenza viruses, demonstrating the protective potential of these epitopes. However, mild side effects, probably attributed to the flagellin, were observed in a few of the participants, as reported earlier in August 2007. Therefore, based on the recommendations of the Scientific Advisory Board, BiondVax decided to discontinue the Phase I clinical trial of the 1st generation vaccine, and to concentrate its efforts on the development of the 2nd generation, Multimeric, non-flagellin based vaccine. An improvement of the 2nd generation vaccine is its facilitated production process. It will be produced as a single protein rather than a combination of 6 separate proteins, as in the 1st generation vaccine. Phase I Clinical Trial is Modified and Extended, August 22, 2007 In April 2007, BiondVax initiated the first Phase I clinical trial in humans at Ichilov Hospital in Israel. The trial design was to inject the Company’s vaccine in three increasing doses to three cohorts of 12 participants each, to be concluded in September 2007. As a result of the occurrence of mild side effects typical of this type of vaccine in a few of the participants, the Company decided, after consultation with the Safety Commission, Principal Investigator, and the hospital Ethics Committee, to reduce the dosage and to resume the trial with more gradual increases in the vaccine doses. As a result, the trial will necessitate the inclusion of a greater number of participants in the first cohort, and the Company expects it to continue until the end of the calendar year. The additional costs of the increased number of participants and the trial extension are estimated at approximately 200,000 NIS (US$50,000). The Company is continuing with development of the second generation Multimeric vaccine. Based on the clinical findings so far, as well as other data, the vaccine will consist of a single protein (as opposed to six proteins in the first generation vaccine) based on the same approach of using conserved antigens as in the first generation vaccine. The Company anticipates that the second generation vaccine will provide a higher safety profile and higher efficacy. Trading Opens for BiondVax Shares on Tel Aviv Stock Exchange, June 18, 2007 In early June 2007, Biondvax made its initial public offering in Israel, raising $3 million through the sale of 3.53 million shares and 350,000 warrants at a price of 3.47 NIS. On Monday, June 18, 2007 BiondVax started trading on the Tel Aviv Stock Exchange under the symbol BNDX. “Universal Flu Vaccine Nothing to Sniff At” – Gate2Biotech “Catching Every Flu” – Jerusalem Report: Jan 23, 2006 “BiondVax Pharmaceuticals gets $1.1m Chief Scientist grant” – Israel Venture Capital Newsletter: Dec. 22, 2005 “Israeli vaccine could provide universal answer to flu epidemics” - Israel 21c: Nov. 6, 2005 “BiondVax flu vaccine heading for clinical trials” – Bioportfolio.com: April 12, 2005 “Israeli company tests long-lasting nose drop vaccine for the flu” – STEPStrategy: July 19, 2004 |
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