Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

Vical Slumps, Cytomegalovirus Vaccine Fails In Phase II Study

By Zacks Investment ResearchStock MarketsSep 20, 2016 04:16AM ET
www.investing.com/analysis/vical-slumps,-cytomegalovirus-vaccine-fails-in-phase-ii-study-200154592
Vical Slumps, Cytomegalovirus Vaccine Fails In Phase II Study
By Zacks Investment Research   |  Sep 20, 2016 04:16AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 

Vical Incorporated (NASDAQ:VICL) and partner Astellas Pharma, Inc. (OTC:ALPMY) announced disappointing top-line data from a phase II study on their experimental cytomegalovirus (CMV) vaccine candidate, ASP0113, in kidney transplant patients. Vical’s shares plunged 22.3% on the news.

The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of ASP0113 in CMV-seronegative kidney transplant recipients, receiving an organ from a CMV-seropositive donor. Data showed that the study failed to meet the primary endpoint, which was the proportion of patients having CMV viremia through one year after first injection of the vaccine.

In addition, the secondary endpoints including CMV-associated disease and CMV-specific antiviral therapy were found to be similar in both treatment groups, as evaluated by an independent, blinded Adjudication Committee.

Although the safety profiles were found to be similar among treatment groups, local injection site reactions were more common in the ASP0113 arm. Additional detailed data from the study is expected to be revealed at an upcoming scientific congress.

Considering that there exists a significant unmet need for treatments addressing CMV, a herpes virus infection, the phase II study results fails to impress.

VICAL INC Price

Vical, however, plans to continue to move with pivotal phase III study on ASP0113 in hematopoietic cell transplant (HCT) recipients, also in collaboration with Astellas. Data from the study is expected in the fourth quarter of 2017. We note that ASP0113 has Orphan Drug status in the both the U.S. and Europe for the prevention of CMV disease in solid organ transplant and HCT recipients.

We remind investors that this is not the first time that Vical has faced a pipeline setback. In 2013, the company had terminated the development of an intratumoral cancer immunotherapy, Allovectin, following negative phase III study results. Further, in 2015, neither its monovalent nor bivalent genital herpes vaccine had met the primary endpoint in a phase I/II study.

Meanwhile, Vical is conducting a phase I study on VL-2397 for the treatment of invasive fungal infections, including invasive aspergillus. We note that Vical had in-licensed the candidate in Mar 2015 from Astellas under an exclusive worldwide license agreement.

Vical carries a Zacks Rank #2 (Buy). A couple of favorably placed stocks in the health care sector are Anika Therapeutics, Inc. (NASDAQ:ANIK) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Confidential from Zacks

Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>



ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

VICAL INC (VICL): Free Stock Analysis Report

ANI PHARMACEUT (ANIP): Free Stock Analysis Report

Original post

Zacks Investment Research
Vical Slumps, Cytomegalovirus Vaccine Fails In Phase II Study
 

Related Articles

Thomas Hughes
Beware The Rebound In Retail Stocks By Thomas Hughes - May 27, 2022

The S&P Retail ETF (NYSE:XRT) is rebounding, but we don’t think investors should cheer too loudly. The move is driven by the combination of oversold markets and mixed...

Jea Yu
Affirm Stock Has Affirmed A Bottom By Jea Yu  - May 27, 2022 1

Buy now and pay later purchase financing provider Affirm Holdings (NASDAQ:AFRM) stock is rebounding after bottoming out at $13.64. The buy-now-pay-later (BNPL) platform had a very...

Vical Slumps, Cytomegalovirus Vaccine Fails In Phase II Study

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Continue with Google
or
Sign up with Email