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Great news!! And thanks for the tip GP100
Vical’s Phase 1/2 Trial Data Presented at ASM 2016 Shows Bivalent Vaccine Imparts Reduction in Genital Herpes Lesions Durable to 9 Months
06/20/2016
Vical plans to advance the bivalent vaccine to a Phase 2 trial in 2016 and maintains current financial guidance for 2016
SAN DIEGO, June 20, 2016 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) presented data from the randomized, double-blind, placebo-controlled Phase 1/2 clinical trial of its therapeutic genital herpes vaccine in symptomatic herpes simplex virus type 2 (HSV-2) infected patients in an oral late-breaker presentation at the American Society for Microbiology (ASM/ICAAC) Microbe 2016 meeting held in Boston. The slides presented by Mammen P. "Anza" Mammen, Jr., M.D., Vical’s Vice President, Clinical Vaccines, will be accessible on Vical’s website.
The per protocol study analyses included 131 evaluable patients: 54 receiving the monovalent (gD) vaccine, 56 receiving the bivalent vaccine (gD + UL46) and 21 receiving placebo. Initial top line 3-month data announced in June 2015 showed that neither the monovalent nor the bivalent vaccine met the primary endpoint of viral shedding rate reduction from baseline. However, the bivalent vaccine achieved statistically significant reduction in a prospectively defined secondary endpoint of genital lesion rate at 3 months versus baseline (-49%, p = 0.031). In the 9-month analysis presented today, the statistically significant reduction in lesion rate compared to baseline for the bivalent vaccine was sustained (-57%, p = 0.009). Furthermore, at the 9-month time point, the bivalent vaccine showed a favorable trend in recurrence rate, time to first recurrence, and proportion of patients who are recurrence-free. Vical’s vaccines elicited significant increases in antigen-specific interferon gamma producing T cells, indicating biologic activity.
An independent Safety Monitoring Board reviewed all adverse events (AEs) and deemed the vaccines to be safe and tolerable in this trial. No serious adverse events, Grade 4 AEs, or AEs of special interest related to vaccinations were observed during the study period. Grade 3 AEs were reported in 13% of subjects, the most common of which were fatigue and injection site pain.
“There remains considerable unmet medical need in the treatment of genital herpes as there have been no new therapeutic breakthroughs in the past several decades,” said Dr. Peter Leone, Professor of Medicine, University of North Carolina and an external program advisor for Vical. “A therapeutic HSV-2 vaccine could represent a very attractive treatment option to reduce outbreaks in individuals who suffer chronically from this disease. The data generated to date with the bivalent HSV-2 vaccine indicate that it is not only immunogenic, but also provides evidence for reducing lesion rate, a clinically meaningful endpoint for patients and physicians. Therefore, the bivalent vaccine warrants further clinical investigation.”
“We have consulted with multiple experts involved in treating patients with genital herpes and conducting clinical trials,” said Vijay Samant, President and Chief Executive Officer. “Our advisors have encouraged us to evaluate the bivalent vaccine further in a follow-on study powered to measure a clinically-relevant endpoint. We have established a continuing dialogue with the FDA about potential next steps and are currently finalizing a clinical protocol based on those discussions. We plan to initiate a Phase 2 trial of the bivalent vaccine during the second half of 2016. Importantly, we expect to be able to execute this study using our current resources and under our operational plan, and maintain our guidance for net cash burn of between $8 million and $11 million during 2016.”
Mr. Samant continued, "We anticipate a number of additional clinical milestones this year. In our CMV program with Astellas, we expect that in the third quarter of 2016, enrollment will be completed in the Phase 3 registration trial in hematopoietic cell transplant recipients and that top line data should be available from the Phase 2 trial in kidney transplant recipients. In addition, we also anticipate completing the Phase 1 trial of our novel antifungal, VL-2397, by year end.”
About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include net cash use guidance, as well as anticipated developments in clinical programs, including the plans, timing of initiation, enrollment and announcement of data for clinical trials, and the potential benefits of Vical’s product candidates. Risks and uncertainties include whether Vical or others will continue development of Vical’s HSV-2 vaccine, ASP0113, VL-2397 or any other independent or collaborative programs; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; whether Vical or its collaboration partners will be able to obtain regulatory allowances or guidance necessary to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether on-going or planned clinical trials will be initiated or completed on the timelines Vical currently expects, whether any product candidates will be shown to be safe and efficacious in clinical trials; whether Vical will have access to sufficient capital to fund its planned development activities; whether Vical will seek or gain approval to market any product candidates; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
Good to see insiders buying
29.61% institutional ownership as well. Perhaps news to come.
Another 9k purchased today
Early PR.
SAN DIEGO, June 13, 2016 (GLOBE NEWSWIRE) -- Vical Incorporated (VICL) announced today that the company will present clinical data on its completed HSV-2 Phase 1/2 trial at the American Society of Microbiology (ASM) Microbe/ICAAC 2016 conference (Boston, June 16 - 20).
Dr. Mammen P. “Anza” Mammen, M.D. Vical’s Vice President, Clinical Vaccines, will present in the conference’s clinical virology session on June 20, 2016 at approximately 10:30 am. Trial results, including safety and efficacy endpoints, will be presented in the oral late-breaker presentation. The slides presented by Dr. Mammen will be available on Vical’s website after the presentation.
Looking at the charts and insider buying this just may be some exciting news to come!
Nice find charliewho, I see here on insider cow. Total of 32,856 sh
http://www.insidercow.com/history/company.jsp?company=vicl&B1=Search%21
3 insider purchases last week, NOT acquired......but purchased. All at higher prices then the current share price.
Nice early volume. Next resistance $5.50
That's from April 26th. Gotta be "new" news coming!! Recent insider purchase also!
Maybe this
AnGes has signed an agreement with Vical Inco
rporated (San Diego, CA
, President & CEO:
Vijay B. Samant) regarding Vical’s DNA va
ccine technology. This agreement gives AnGes
the rights to exclusively develop and commercia
lize the equine polyclonal antibody therapy in
Japan.
http://s1.q4cdn.com/508380786/files/doc_downloads/AnGes-Ebola-PR/AnGes-U.-of-Saskatchewan-Ebola-Collaboration.pdf
Excellent volume today. Something cooking here
Never been that high. You forgot to factor in the Jan 2016 1/15 R/S.
Even so, it is well off it's historic highs as stated.
With only 13.4million O/S it would not take much for it to run again.
That could be something to get exited about. Ya never know, lol, since it still had a great run.
If VICL has such a run then yes, the excitement would be warranted as it would make a lot of green here.
VICL has 9.4million O/S and 35% "tute" ownership after its R/S so float now only around 6million shares.
Add news and stir. Voila, nice profits.
VICL News: Current Report Filing (8-k) 05/25/2016 09:01:42 AM
VICL News: Statement of Changes in Beneficial Ownership (4) 05/24/2016 12:14:41 PM
VICL News: Statement of Changes in Beneficial Ownership (4) 05/24/2016 11:33:43 AM
VICL News: Statement of Changes in Beneficial Ownership (4) 05/24/2016 11:28:01 AM
VICL News: Statement of Changes in Beneficial Ownership (4) 05/24/2016 11:25:39 AM
Vical Incorporated (VICL)
3.958 ? 3.578 (941.58%)
Volume: 69,111 @ 11:49:46 AM ET
Bid Ask Day's Range
3.95 3.99 3.75 - 4.07
VICL Detailed Quote
Reverse splits are almost always a LOSER'S ploy.
Another loser's ploy are stocks touted by goodplenty100.
$VICL On May 20, 2016, the Company's stockholders approved an amendment to the Company's Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company's common stock at a ratio of not less than 1-for-10 and not more than 1-for-30, as determined by the Board of Directors at its discretion. Subsequent to the stockholders' approval, the Company's Board of Directors approved a reverse split ratio of 1-for-10. On May 25, 2016, the Company filed with the Delaware Secretary of State a certificate of amendment to its Amended and Restated Certificate of Incorporation to implement the reverse split at the approved ratio. The reverse split will be implemented as of 5:00
p.m. Eastern time on May 26, 2016, and the Company's common stock will begin trading on a split-adjusted basis on May 27, 2016.
http://bit.ly/1sSJ4OV
reverse split tomorrow
His position is the only reason the PPS rose to begin with. Now we are seeing a retrace back down to the previous levels. He won't sell until closer to the June data and usually for a 8% gain unless something suggests otherwise.
Don't keep your short position too long....
best to sell now before Sheff does. This thing is treading on thin ice. Looks like it may head much lower.
AMDA $80 2 yrs ago and now under $2?? And you're excited about this?
$heff Member Level Tuesday, 05/10/16 01:57:09 PM
Re: $heff post# 93699
Post # of 93942
Beginner Portfolio Update..entered a stock in a company that had upcoming catalysts w/ a late breaker presentation on 6/20.
Alert..bought $VICL (20%) pstn at $.3825 in the Beginner Portfolio Economy. Looking for this to gain some solid momentum into their Late Breaking Presentation date. $VICL also has another catalyst shortly after that one. Company is trading near 52wk low of $.28. Company has 39m in cash & book value is $.52/share. Phase 2 data w/ SOT expected in 3Q16. $VICL has 28m shares o/s as of 3/15/16.
Disclaimer: http://bit.ly/OlN9DB
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122535244
I found the 8k from 2015. Warning issued. Here are the details. Feb 1 2016 on deck
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
On August 5, 2015, Vical Incorporated (the “Company”) received a letter from The Nasdaq Stock Market indicating that for
30 consecutive business days the Company’s common stock had not maintained a minimum closing bid price of $1.00 per share (“Minimum Bid Price Requirement”) as required by Nasdaq Listing Rules. This notice of noncompliance has had no immediate impact on the continued listing or trading of the Company’s common stock on the Nasdaq Global Select Market.
Under Nasdaq Listing Rule 5810(c)(3)(A), if during the 180 calendar days following the date of the notification (the “Compliance Period”) ending on February 1, 2016, the closing bid price of the Company’s common stock is at or above $1.00 for a minimum of ten consecutive business days, the Company will regain compliance with the Minimum Bid Price Requirement and the common stock will continue to be eligible for listing on the Nasdaq Global Select Market.
If the Company does not achieve compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, under Nasdaq Listing Rule 5810(c)(3)(A)(ii), if on the last day of the Compliance Period, the Company is in compliance with the market value requirement for continued listing, as well as all other standards for initial listing of its common stock on the Nasdaq Capital Market (other than the Minimum Bid Price Requirement), and the Company provides written notice of its intention to cure the deficiency during a second compliance period, Nasdaq may grant the Company an additional Compliance Period through August 1, 2016.
If the Company receives a Staff Delisting Determination, the Company may, at that time, request in writing that a Nasdaq Hearing Panel review the matter in a written or an oral hearing. Such a review, if granted, would stay delisting until a Panel ruling. After the Nasdaq Hearing Panel determination is final, the Company may then appeal the Hearing Panel decision to the Listing Council. If granted, such an appeal would not stay the Hearing Panel decision.
The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement under the Nasdaq Listing Rules.
Has there been any notices from Nasdaq about vical not being in stock price compliance? It's been under a buck for a long time. Reverse split coming?
This will be the next AMDA!!!! I see light at the end of the tunnel
VICL is the orphan, all right...34.5 cents, LOL.
VICL news: FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis
Vical (NASDAQ:VICL)
Intraday Stock Chart
Vical Incorporated (Nasdaq:VICL), a biotechnology company developing vaccines and therapeutics for prevention and treatment of infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Vical orphan drug designation for its investigational antifungal product candidate, VL-2397 for the treatment of invasive aspergillosis. VL-2397 is also known as ASP2397 and Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III). Orphan drug designation provides several benefits to Vical, including a seven-year period of market exclusivity in the United States.
“We are pleased that the FDA has granted Vical orphan drug designation to develop VL-2397 for the treatment of invasive aspergillosis,” said Mammen P. Mammen, Jr., M.D., Vical’s Vice President of Clinical Vaccines. “This is in addition to the qualified infectious disease product (QIDP) designation that FDA granted Vical for VL-2397 for the treatment of invasive aspergillosis in August 2015. We are excited by the potential for VL-2397 to save lives of patients with systemic fungal infections such as aspergillosis. We plan to initiate a Phase 1 clinical trial in the first half of 2016.”
VL-2397 is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections. Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in intensive care units. In preclinical studies to date, VL-2397 has demonstrated both faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. VL-2397 was initially developed by Astellas Pharma Inc. (TOKYO: 4503). In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.
About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include the potential benefits of VL-2397 and orphan drug designation, Vical's capabilities to develop VL-2397 and Vical's development plans and timelines for VL-2397. Risks and uncertainties include whether Vical or others will continue development of VL-2397; whether planned clinical development of VL-2397 will begin when expected, or at all; whether the results of future preclinical or clinical studies will be consistent with prior preclinical studies or will otherwise merit further development; whether Vical or its collaborative partners will seek or gain approval to market any product candidates, including VL-2397; whether Vical will be able to realize any of the potential benefits of orphan drug designation for VL-2397; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Happy New Year to the Board
May this year be the year for us!!
Thanks to Daniel Ward for the following
Vical Incorporated (NASDAQ:VICL) - 10% Allocation: Vical Incorporated is a new name I ran into while reviewing my cheap biotech screen. Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases. When you see me highlighting this name, you may be saying the following:
"Dan, what are you thinking? Did you see the phase 1/2 failure for its therapeutic genital herpes vaccine in June 2015 or the phase 3 failure for intratumoral cancer immunotherapy Allovectin back in August 2013?"
Yes, yes I definitely am aware of its history of futility. Even given this, take a look at the following thesis points highlighting why I believe this stock presents a compelling opportunity:
1. Clean Capital Structure and Rock-Bottom Valuation: Typically biotechs with a history of futility at what appear to be low valuations will have poor capital structures (think Aeterna Zentaris (NASDAQ:AEZS) ), which spells doom for shareholders. Utilizing control+F through a few SEC filings will show you that Vical refreshingly has no outstanding warrants or preferred stock. So, exactly how cheap is it? Well, at a price to book ratio of 0.694x, the stock is the cheapest it's been in the past five years.
VICL Price to Book Value Chart
VICL Price to Book Value data by YCharts
As a matter of fact, you'd have to go back more than a dozen years to find when the stock was this cheap.
VICL Price to Book Value Chart
VICL Price to Book Value data by YCharts
Coincidentally, twelve or so years ago is roughly when notable value investor John Rogers and Ariel Investments initially took a stake in the name. You can read about Ariel's history with the name in a piece by ValueWalk here. While Ariel has managed its position by selling the rips and buying the dips as it kept weightings in line, the company still currently owns approximately 8.1% of the company. Given the company's value investing strategy of exhibiting discipline and capitalizing on mispricings, I believe that the company will consider increasing its stake at current levels. While a clean capital structure and trading well under book value provide are both quality characteristics for a value investment, the company's partnership with Astellas is what clinches the company's spot in my value investment portfolio. My reason for being very positive on this partnership with Astellas is that Astellas is currently funding the ASP0113 program, which includes multiple late-stage trials with a phase 2 solid organ transplant (SOT) trial and a phase 3 hematopoietic cell transplantation (HCT) trial. With Astellas funding multiple late-stage trials, the company is projected to only burn $7-9 million in 2015, and I expect the company to be able to continue to manage cash burn in 2016 thanks to Astellas.
2. Variety of Upcoming Catalysts: While I admittedly do not have a specific catalyst to point to that will rescue shares from a valuation not seen since the early 2000s, there are a nice set of catalysts to note, and it will only take one piece of notable positive news to provide investors with a solid return from current levels. Catalysts on deck include the following:
(click to enlarge)
Source: November 2015 Stifel Conference
ASP0113 Program: From this program partnered with Astellas, we'll receive phase 2 data in SOT in Q3 2016. In this phase 2 study, the company is looking at the highest risk patients where an organ is being transferred from a cyatomegalovirus (CMV) positive donor to a CMV negative recipient. We're also expected to receive an enrollment completion milestone for the phase 3 HCT trial in Q3 2016.
HSV-2 Therapeutic Vaccine: As I previously mentioned, the company failed a top-line efficacy readout for the phase 1/2 trial in June 2015. While herpes vaccine development is difficult and the data was very poor, the company will be reporting additional clinical data in the first quarter of 2016 that will include the change in lesion rate and recurrence data. While I have low hopes for value creation from this asset, there was biological activity data that was a bit interesting in the initial readout, and it should not take much to get the name moving upward from this depressed valuation.
CyMVectin CMV Vaccine: The company is exploring this asset in the treatment of women of childbearing age as a way to prevent CMV infection in this at-risk group of women and their children. The company has a phase 1 trial design and has an IND that has been allowed by the FDA. It is reviewing options to move forward individually or with a partnership with a partnership providing an interesting catalyst and a method for cash-burn control.
VL-2397: VL-2397 is an anti-fungal compound the company in-licensed from Astellas with Vical completing this deal with stock and $250,000 in cash. The company will be initiating a phase 1 trial in H1 2016 for treatment of invasive aspergillosis. Lack of research in anti-fungals makes this an area of research with a number of financial incentives with the company eligible for certain incentives through the GAIN Act of 2012.
Concluding Thoughts On Vical: While I acknowledge the lack of success on the part of Vical in past years, this is a company with a clean capital structure, a partner in Astellas funding substantial R&D, and minimal cash burn that currently trades well under book value. I believe that there are ample catalysts on deck to drive value creation for shareholders over the next year.
http://seekingalpha.com/article/3779066-biotech-weekly-top-value-biotech-picks-for-2016
"VICL ...BUILDING STEAM...watching for .48 break"
LOL, now at 36 pennies. Building steam...good one.
Thanks and I 'll take a look.....
I did really well with TCLN....
Welcome seasonedwell good to have you aboard!
Check out the below link and see where VICL sits.
This link is complements of biopharm on the PPHM board.
https://www.tipranks.com/analysts/debjit-chattopadhyay
You got it.......
Vical Incorporated (VICL) -NasdaqGS
0.51 Up 0.04(7.92%)
VICL ...BUILDING STEAM...watching for .48 break
Vical has filed thirteen investigational new drug applications to conduct clinical trials and holds four master files for manufacturing recombinant DNA products.
Vical has completed more than thirty clinical trials with recombinant DNA products. These Phase 1 – Phase 3 trials of vaccines or gene therapy products have been conducted in up to 15 countries.
Avg Vol (3 month): 256,106
Avg Vol (10 day): 442,712
I'm moving on it...... I believe it's time to buy...
VICL selling for cash on the balance sheet.....
Total Cash Per Share (mrq): 0.42
Of coarse....
Operating Cash Flow (ttm): -7.76M
Levered Free Cash Flow (ttm): -4.10M
Shares Outstanding5: 91.52M
Float: 81.63M
% Held by Insiders1: 20.14%
% Held by Institutions1: 26.40%
Shares Short (as of Oct 30, 2015)3: 190.36K
Short Ratio (as of Oct 30, 2015)3: 0.62
Short % of Float (as of Oct 30, 2015)3: 0.21%
Shares Short (prior month)3: 330.40K
VICL, started a position here over the last week.....
No debt and Total Cash (mrq): 38.60M
Pathetic garbage. Ole Vijay needs to do a lot more "discussing" about this smelly trash.
You're welcome ......... plenty more where that came from .....:
http://DDAmanda.com
z
Thanks for the peak
VICL~ makin' the muv's today!
Vical beats by $0.04, beats on revenue
SAN DIEGO (AP) _ Vical Inc. (VICL) on Thursday reported a loss of $300,000 in its third quarter.
On a per-share basis, the San Diego-based company said it had a loss of less than 1 cent.
The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 4 cents per share.
The drug developer posted revenue of $5 million in the period, also beating Street forecasts. Three analysts surveyed by Zacks expected $3.9 million.
The company's shares closed at 39 cents. A year ago, they were trading at $1.18.
Vical Announces News Release and Conference Call Schedule for Third Quarter 2015 Financial Results
Vical Incorporated (Nasdaq:VICL) today announced that the company will report financial results for the three and nine months ended September 30, 2015, before the opening of trading on Thursday, October 29, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Thursday, October 29. The call will be open on a listen-only basis to any interested parties. The company will also provide a business update, including details on independent and partnered development programs in the conference call and webcast.
Conference Call
To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 325-2376 (preferred), or (888) 401-4669 (toll-free), and reference confirmation code 3993142. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 3993142. The call also will be available live and archived through the events page at www.vical.com.
Invited participants may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to ir@vical.com or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical's Investor Relations department by phone at (858) 646-1127 or by email at ir@vical.com.
About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.
CONTACT: Andrew Hopkins
(858) 646-1127
Website: www.vical.com
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Vical's proprietary core technology is based on plasmid DNA (pDNA), closed loops of DNA that encode any protein of interest. When injected into tissues such as skeletal muscle or the skin, cells take up pDNA and produce the encoded protein. This allows for pDNA to be used as the basis for a broad range of biopharmaceutical products: infectious disease vaccines (delivering antigens from viruses, bacteria, or parasites), cancer vaccines or immunotherapeutics (delivering tumor antigens or immunostimulatory proteins), and growth factors to stimulate angiogenesis and tissue repair in diseases such as cardiovascular disorders.
Since its initial discovery, Vical has continued to improve its DNA delivery technology so as to maximize gene expression as well as the body's response to the proteins produced. For example, we optimize the DNA sequences that make up our pDNA, and we continue to develop new formulation and delivery technologies, including the use of lipid molecules (which can function as vaccine adjuvants) and synthetic polymers such as poloxamers.
Plasmids are manufactured in Vical's cGMP facility in San Diego using uniform methods of bacterial fermentation and processing, which allows faster development and production times than technologies that require development of product-specific processes. In addition, since our product candidates contain no viral components they are designed to avoid unwanted immune responses, infections, or malignant changes in a cell's genetic makeup, and have been administered repeatedly with a very favorable safety profile in clinical trials to date.
http://www.vical.com/technology/vaxfectin/default.aspx
http://www.vical.com/technology/publications/default.aspx
Vical has filed thirteen investigational new drug applications to conduct clinical trials and holds four master files for manufacturing recombinant DNA products.
Vical has completed more than thirty clinical trials with recombinant DNA products. These Phase 1 – Phase 3 trials of vaccines or gene therapy products have been conducted in up to 15 countries.
Check back frequently for updates on future enrollments or connect with us through or connect with us on or .
Phase 3 Clinical Trial: ASP0113 Therapeutic Cytomegalovirus (CMV) Vaccine
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT). For more information, please go to the NCT01877655 trial listing at ClinicalTrials.gov.
Phase 2 Clinical Trial: ASP0113 Therapeutic Cytomegalovirus (CMV) Vaccine 1
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor. For more information, please go to the NCT01974206 trial listing at ClinicalTrials.gov.
Phase 1/2 Clinical Trial: Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults. For more information, please go to the NCT02030301 trial listing at ClinicalTrials.gov. ?
$VICL recent news/filings
Many thanks to stocktrademan for post #774
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