Admedus’ (ASX: AHZ) final results from its Phase I Herpes Simplex Virus (HSV-2) vaccine study has showed that 95% (19 of 20) of the participants had a positive T-cell response when the trial reached is primary endpoint of safety.
Shares in the company should trade higher on the results, which support the progress of the vaccine into a Phase II study by the end of 2014.
The company also noted that the T-cell responses were clearly dose dependent.
The vaccine was developed by Chief scientific officer Professor Ian Frazer and his science team at Admedus Vaccines to prevent transmission of as well as treat herpes simplex virus 2 (HSV-2) by stimulating the immune response to enable a patient to fight against diseases.
“The very encouraging results, clean safety profile and cellular immune responses demonstrated in this HSV-2 study are particularly encouraging and validate the potential of our range of therapeutic vaccines which utilises Professor Frazer’s novel immunotherapy technology,” chief executive officer Lee Rodne said.
“We are looking forward to advancing our HSV-2 vaccine into a Phase II clinical study later this year. We will continue advancing our vaccines to treat Human Papillomavirus and cervical cancer.”
“The clean safety profile and strong dose-dependent cellular immune responses observed, following intradermal injection of the HSV-2 vaccine in this study, were as expected with this vaccine technology.
“The results support the progression of this vaccine candidate into Phase II studies.”
Admedus has a 66% interest in Admedus Vaccines.
Phase I Study Results
The Phase I study was undertaken in healthy volunteers who were confirmed sero-negative for the HSV-2 virus, with subjects screened prior to vaccination, to explore safety, as well as to examine any immune response.
19 of the 20 study subjects generated a positive T-cell response (HSV-2 cell mediated immunity) as defined in the clinical trial protocol.
One study subject in the 3rd lowest dose (100 mcg) did not show an immune response.
The cell mediated immunity response shown in this study, where the study subjects had no previous HSV-2 infection, demonstrates utility of this vaccine.
Over the course of the study, the 3 intradermal injections of the vaccine were found to be safe and well tolerated with some local redness being observed post injection which dissipated over time.
During the study minor adverse events (AEs) were reported but considered unrelated to the vaccine. One serious adverse event (SAE) was also reported during the study; however this were unrelated to the vaccine.
In addition, there was a local immune response at the site of injection, a delayed-type hypersensitivity (DTH) response, 24 and 48 hours after each vaccination.
These results showed a clear dose response over the 3 injections and illustrated that patients confirmed to be sero-negative for HSV-2 had generated an immune response to the vaccine.
The DTH response is a cell mediated response. The cascade of events initiated by the T cells leads to hardening (induration) and redness (erythema) at the injection site, which was clearly evident in these study subjects.
The safety profile and the detected immune response provides the basis for the company to select appropriate vaccine doses to progress the therapeutic vaccine into a Phase II study in individuals suffering recurrent genital lesions.
The Phase II study is anticipated to be initiated by the end of the year. This will examine the safety of the vaccine in people infected with the virus as well as the immune response in these people.
HSV-2 genital herpes
Genital herpes affects more than 1 in 6 Americans between ages 14 and 49 according to the U.S. Centers for Disease Control.
WHO estimates the number of people aged 15–49 years who are living with HSV-2 worldwide exceeds half a billion.
Most individuals infected with HSV-2 experience either no symptoms or have very mild symptoms that go unnoticed or are mistaken for another skin condition and as a result are often unaware of their infection until an outbreak occurs.
Notably, there is currently no cure for HSV-2.
Proactive Investors believes that having 95% of the participants (19 out of 20) in the Phase I trial for the HSV-2 vaccine reporting a positive T-cell response is very promising for Admedus and sets the stage for the Phase II clinical trial, which is targeted to begin by the end of 2014.
The trial also achieved its primary endpoint of safety.
We believe that given the high infection rate and lack of any cure for HSV-2, the early successes of the company’s vaccine has the potential to open up a massive market that has not being tapped.
The response also supports the company’s efforts to advance its vaccines to treat Human Papillomavirus and cervical cancer, which could open up further markets for the company.
Upcoming share price kickers include:
- Extending the use of CardioCel® for an expanded range of indications in cardiovascular surgery;
- Expanding regenerative tissue portfolio and explore the use of ADAPT® prepared tissue for additional surgical applications that have the potential to increase revenue in the future;
- Initial Asian market approval for CardioCel®;
- Initiation of HSV-2 Phase II examine the safety of the vaccine in people infected with the virus as well as the immune response in these people.; and
- Initiation of HPV Phase I.
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