Vical ついに語る…！

以前、「Vical HSV2ワクチン情報！」で紹介した抗HSV2ワクチンですが、どうやらかなり本格的に動いているようですね…。

同社が開発している抗HSV2ワクチンは、自社製免疫機能活性剤（アジュバント）Vaxfectinを使ったもので、かなり高い効果を示したようなのですが（効果については先に紹介した記事を参照してください）、今後の予定としては…、

• ヒトを使った治験を行うが、その前にHSV2感染者を対象としたやや小規模なPhase I、II治験を行い、最初の関門である効果と安全性についてのデータを収集するようにする

ようです。

Vicalの方針としては…、

　　「このHSV2ワクチン開発は会社の最優先事項の一つである」

ようでして、今後に期待したいところです！

他のバイオ系研究・開発所と異なり、資金も豊富で、多くの治験が進行しているようですので、資金・経験という点から見てもかなり期待できるかもしれません☆

ちょっとこれから注目株ですね！



Vical Incorporated's CEO Discusses Q3 2011 Results - Earnings Call Transcript

http://seekingalpha.com/article/304131-vical-incorporated-s-ceo-discusses-q3-2011-results-earnings-call-transcript

From Vijay Samant – President and Chief Executive Officer

..."Let me now move to Herpes Simplex 2 program. This is the therapeutic vaccine for Herpes simplex 2 represents the large potential market opportunity which have conservatively estimated at more than $1 billion. The prevalence in the U.S. alone is estimated to around 15 million people, with about 20 million or 10 million people suffering from period outbreaks of general wards. The other 80% are asymptomatic, but can still shed virus and transmitted to their sexual partners. Since our last call, we presented new data at scientific conference from our latest studies of our therapeutic vaccine and standard guinea pig herpes model.

Our Vaxfectin formulated vaccine against HSV to provide a complete protection in guinea pigs against both primary and recurrent HSV-2 disease. The vaccines also significantly reduced genital lesion recurrence and viral shedding as well as latent infection in the central nervous system. Collective results from our pre-clinical studies include the following.

Prophylactic vaccines encoding glycoprotein D plus or minus, two herpes virus tegument proteins provided complete protection from both primary and recurrent disease; the prophylactic vaccines also significantly reduced viral replication at primary infection site as well as detectable virus at the latent site; therapeutic vaccines encoding glycoprotein D plus, the two tegument protein significantly reduce the frequency of general lesion outbreaks in animals with pre-established HSV to infections; the therapeutic vaccines also significantly reduced the frequency of general viral shedding. These are superb results and we are working now to complete preclinical development and prepare our plan to advance the therapeutic vaccine into human clinical testing. We believe a relatively small and quick Phase I, II study should be conducted in infected volunteers to provide initial human safety and proof-of-concept data. The program is high on our priority list and we look forward to defining a path forward in the near future.

We expect continued progress on our independent and partnered programs through the year-end 2012 into 2012. In our Phase III trial for Allovectin, we expect to complete treatment and follow-up for the primary endpoint by Feb of 2012, that’s a two-year follow-up, and to release top line data from both primary and secondary endpoints in the second quarter of 2012. In our TransVax CMV vaccine program, we expect Astellas to initiate a Phase III trial in stem-cell transplant recipients and a Phase II trial in solid organ transplant recipients in the first half of 2012. Our Japanese partner, AnGes, has recently updated its guidance and now expect to initiate a multinational Phase III clinical trial of its Collategene angiogenesis product in 2012. We expect to end the year with cash and investments of $53 million to $56 million.

Source: http://seekingalpha.com/article/3041...all-transcript - November 1, 2011