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ContraVir Pharmaceutcals (CTRV)

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Last Post: 5/19/2019 9:40:11 AM - Followers: 56 - Board type: Free - Posts Today: 0


ContraVir is developing drug candidates for expanding market segments with high unmet need.



Hepatitis B is an infectious disease caused by the hepatitis B virus (“HBV”). Individuals who develop chronic HBV are at much greater risk for liver disease later on in their life. The greatest risk posed is potential cirrhosis of the liver and hepatocellular carcinoma. The U.S. is the largest individual market and is growing rapidly.


Herpes zoster, also commonly known as shingles, is a neurological disorder caused by the reactivation of varicella zoster virus, the same virus that causes chicken pox. Based on recent research and publications, we estimate that there are over four million cases of shingles in the U.S., Europe and Japan each year.


ContraVir is dedicated to serving patients and healthcare professionals by developing clinically-differentiated therapeutic products that address high-need market segments. ContraVir brings its financing, product development, and commercialization expertise to create long-term value for partners with unique clinical candidates.

TXL™ Phase 1

Title: A Phase 1, Randomized, Partial-Blind, Placebo-controlled, Sequential Dose Group, Ascending, Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics, With Food Effect, of TXL™ in Healthy Subjects

Condition: Infectious Disease

Interventions: TXL™; Placebo


Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at increasing dose levels

Secondary Objective: To evaluate the pharmacokinetics of multiple doses of TXL™ at increasing dose levels, in a fasted state; to evaluate the pharmacokinetics of a single dose of TXL™ 50 mg in a fed state


Age: 18 years to 55 years

Gender: Both

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Capable of giving written informed consent
    Capable of completing study requirements

Exclusion Criteria:

  • Positive result for HIV, HBV, or HCV
    History or medical condition which could impact patient safety
    Current or past abuse of alcohol or illicit drugs
    Participation in another clinical trial within the past 30 days

Hepatitis B

ContraVir is developing Tenofovir Exalidex (TXL™) for Hepatitis B in Phase 2 clinical studies. TXL™ is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent of tenofovir, marketed by Gilead as Viread®.

TXL™’s novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects. TXL™ has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability, and drug distribution profile.

ContraVir believes a potentially best-in-class antiviral like TXL™ can become the cornerstone of a curative combination therapy for hepatitis B. The combination would include multiple drugs that inhibit different points in the viral life cycle, such as ContraVir’s cyclosporine A-derived antiviral TXL™, which is currently in preclinical development.

Potential Advantages of TXL™ over Tenofovir
  • Increased efficacy by boosting bioavailability
    Takes advantage of natural lipid uptake mechanisms
    Decreased renal toxicity by reduced circulating TFV
    97-fold more active against HBV in vitro



Title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TXL™ in HBV-infected Subjects

Condition: Infectious Disease

Interventions: TXL™; TDF (Viread)



Primary Objective: To evaluate the safety and tolerability of multiple oral (PO) doses of TXL™ at multiple ascending dose levels; to evaluate the antiviral activity of TXL™ versus Tenofovir disproxil fumarate (TDF; Viread)

Secondary Objective: To evaluate the pharmacokinetics (PK) of multiple doses of TXL™ at multiple dose levels in a fasted state


Age: 18 years to 65 years

Gender: Both

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Capable of giving written informed consent
    Capable of completing study requirements
    Chronic hepatitis B positive
    HBV treatment naïve

Exclusion Criteria:

  • Positive result for HCV (hepatitis C virus), HDV (hepatitis D virus) or HIV (human immunodeficiency virus)
    History or medical condition that could impact patient safety
    Current or past abuse of alcohol or illicit drugs
    Abnormal laboratory value or ECG
    Pregnant or breastfeeding
    Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis
    Systemic immunosuppression
    Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug


Hepatitis B

ContraVir is developing CRV431 for treating hepatitis B and is currently preparing to enter IND-enabling studies based on strong preclinical data. CRV431 belongs to a known drug class of cyclophilin inhibitors derived from cyclosporine A, and was designed specifically to optimize potency and selectivity against HBV.

CRV431 works by disrupting certain host mechanisms that are “hijacked” by HBV as it replicates within liver cells. It is expected to be effective against all HBV genotypes due to the fact that it interrupts more than one point in the viral life cycle that are common in all HBV sub-types.

Potential Advantages of CRV431
  • Best-in-class potency and selective index against HBV
    Interrupts HBV at multiple points, limiting replication and potential resistance
    Blocks HBV entry into liver cells and suppresses HBsAg and HBeAg in vitro
    Reduces HBV DNA without toxicity; prevents liver fibrosis in vivo


Valnivudine™ Phase 3



Title: A Multicenter, Randomized, Double-Blind, Parallel Group, Comparative Study of Valnivudine™ vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster-Associated Pain

Condition: Shingles/Herpes Zoster

Interventions: Valnivudine™; Valacyclovir

Learn about the Valnivudine™ Clinical Trial at GotShingles.com >>


Primary Objective: To evaluate the incidence of post-herpetic neuralgia (PHN) following treatment with 2 dose regimens of Valnivudine™ compared to Valacyclovir

Secondary Objectives: To evaluate the effect on pain associated with acute herpes zoster (AHZ) of 2 dose regimens of Valnivudine™ compared to Valacyclovir; to describe the effect on lesion formation and healing of 2 dose regimens of Valnivudine™ compared to Valacyclovir

Safety: To evaluate the safety profile of 2 dosing regimens of Valnivudine™ as compared to Valacyclovir

Pharmacokinetic: To evaluate the pharmacokinetic (PK) profile of the active metabolite (CF-1743) of Valnivudine™ after 7 days of dosing at 400 mg once-daily (QD) compared with 400 mg twice-daily (BID)

Methodology: A multicenter, randomized, double-blind, parallel-group, active-controlled comparative study of the safety and efficacy of 2 dosing regimens of Valnivudine™ versus Valacyclovir administered for 7 days in subjects with uncomplicated AHZ. Subjects diagnosed with uncomplicated AHZ within 120 hours of lesion appearance and Worst Pain in the Last 24 hours of ≥4 (0-10 numerical rating scale) at Visit 1/Day 1, will be randomized (1:1:1) to one of 3 treatment groups and will begin study treatment at Visit 1/Day 1 to either:

  • Valnivudine™ 400 mg QD
    Valnivudine™ 400 mg BID (total daily dose of 800 mg)
    Valacyclovir 1000 mg 3 times a day for a total daily dose of 3000 mg

Efficacy assessments for lesion status and AHZ pain are captured until Day 120.

Post-herpetic Neuralgia (PHN)

We are developing Valnivudine™ as a fast-acting, low-dose, once-daily, oral antiviral therapy for the treatment of herpes zoster, or shingles, an infection caused by the reactivation of the varicella zoster (chicken pox) virus. In addition to its potent antiviral activity, Valnivudine™ has demonstrated an ability to reduce the incidence and severity of debilitating shingles-associated pain, known as post-herpetic neuralgia, or PHN.

We are currently conducting a pivotal Phase 3 trial that will compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.


Driven primarily by the aging adult population, the rate of shingles is increasing steadily. Recent research estimates there are more than four million cases of singles each year in the major markets of the U.S., Europe, and Japan, of which more than half occur in the U.S. Further, approximately two-thirds of shingles patients suffer from pain for 30 days or longer. Learn more about shingles and shingles pain >>

The pain associated with an episode of shingles is attributed to both the damage caused to the affected nerves by the replication of varicella zoster virus and the inflammatory response associated with the infection.

For many patients, shingles-associated pain does not resolve when the lesions heal and the inflammation subsides, but, rather, continues for months, or possibly years. Shingles-associated pain, or PHN, is the most common and clinically relevant complication of shingles.

Post-herpetic Neuralgia (PHN)
  • Mild to excruciating pain long after shingles rash resolves
    >65-70% of shingles patients suffer from PHN for 30 days or more; can last for 2-3 years
    Disrupts sleep, mood, work, and activities of daily living


  • Rapid onset of action for quick pain relief
    Higher potency vs. approved agents against herpes zoster
    Efficacy profile superior to valacyclovir
    Potential for QD dosing vs. 3-5x daily for valacyclovir
    No dose adjustments needed for patients with renal insufficiency

Clinical Data

Phase 1 and 2 trials of Valnivudine™ were successfully completed. We are currently conducting a pivotal Phase 3 trial in patients with shingles to further explore Valnivudine’s™ potential ability to reduce shingles pain.

Demonstrated Safety and Efficacy
  • >350 patients treated with Valnivudine™
    Clinically meaningful reduction in PHN occurrence versus valacyclovir
    Meaningful reduction in time to resolution of clinically significant pain
    8-10% fewer patients required narcotics for pain control
    Safety similar to other antivirals

Phase 3 Study

ContraVir’s pivotal Phase 3 study seeks to compare Valnivudine™ to valacyclovir (Valtrex®) with shingles pain reduction as a primary endpoint.
Phase 3 Study Design
  • Multi-center, randomized, double-blind, parallel-group, comparative study (Valnivudine™ vs. valacyclovir)
    Up to 200 centers (U.S. only)
    Three-arm study: Valnivudine™ 400mg QD, Valnivudine™ 400mg BID, Valacyclovir 1000mg TID
    985 patients estimated with 275 patients per arm
    Patients aged 30 years and older
    Seven day treatment period; follow up through day 120

Scientific Research

Pharmacokinetic data from completed Phase 1 and 2 clinical trials suggest that Valnivudine™ has the potential to demonstrate antiviral activity when dosed orally once-a-day at significantly lower blood levels than acyclovirvalacyclovir, and famciclovir, the FDA-approved drugs used for the treatment of shingles.


  •                                 TXL™ composition of matter to 2031
                                   CRV431 composition of matter to 2031
                                 Valnivudine™ composition of matter to 2027


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CTRV News: Securities Registration Statement (s-1) 05/20/2019 02:46:01 PM
CTRV News: Quarterly Report (10-q) 05/15/2019 05:46:52 PM
CTRV News: Current Report Filing (8-k) 05/08/2019 04:39:59 PM
CTRV News: Current Report Filing (8-k) 05/06/2019 12:56:18 PM
CTRV News: ContraVir Pharmaceuticals Receives Positive Nasdaq Listing Decision 05/06/2019 08:00:00 AM
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#770   $ctrv $.25 with news Taurus69 05/19/19 09:40:11 AM
#769   8K on May 02. Is this still good? FUBAR 05/13/19 06:20:17 AM
#768   $ctrv what’s this about a split? Taurus69 05/12/19 10:54:51 PM
#767   $ctrv current filings. Pps going up! Taurus69 05/12/19 10:53:29 PM
#766   $ctrv starting in the green. Taurus69 05/12/19 10:52:07 PM
#765   $ctrv $.25 game on! Taurus69 05/12/19 10:47:40 PM
#764   * * $CTRV Video Chart 05-09-2019 * * ClayTrader 05/09/19 05:39:56 PM
#763   Games by the Company and Tutes are in 420man 05/08/19 07:09:50 PM
#762   Most of these penny stocks are our casinos. RJ Trotts 05/03/19 11:56:46 PM
#761   I don't think some traders understand that the 420man 05/03/19 06:55:36 PM
#760   Let's see me a green Friday Samick 05/03/19 03:55:30 PM
#759   So no worries about the upcoming R/S? FUBAR 05/03/19 03:09:11 PM
#758   I am ready for this one Samick 05/03/19 02:43:38 PM
#757   I'm ready!! Juschilln 05/03/19 11:43:22 AM
#756   Dump incoming... :( 420man 05/03/19 09:08:32 AM
#755   And there's the RS... https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148458480 420man 05/02/19 06:59:18 PM
#754   Oops, wrong board. Marilynt 05/02/19 05:14:15 PM
#753   * * $CTRV Video Chart 05-02-2019 * * ClayTrader 05/02/19 04:50:51 PM
#752   Whew! LOL! Did pretty good today. Juschilln 05/02/19 04:32:24 PM
#751   Your green again, nice job! homeboy4u 05/02/19 02:03:12 PM
#750   Whooops! Juschilln 05/02/19 11:19:24 AM
#749   Came a little late to the party. Juschilln 05/02/19 11:02:35 AM
#748   Did you get any yet? That was a homeboy4u 05/02/19 10:54:02 AM
#747   $CTRV Down in PreMarket CrownCannabis 05/02/19 09:19:00 AM
#746   Nooooooooooooooooooooo! I need this to drop back Juschilln 05/02/19 08:50:07 AM
#745   Good morning, let’s test .20 today homeboy4u 05/02/19 06:52:51 AM
#744   Nice push today, but didn't hit my sell 420man 05/01/19 06:45:48 PM
#743   * * $CTRV Video Chart 05-01-2019 * * ClayTrader 05/01/19 04:26:12 PM
#742   If it can hold above 16 should be JJGl 05/01/19 02:37:14 PM
#741   There comes the dump imo Roadtojourney 05/01/19 02:10:28 PM
#740   This one is getting crazy volume! homeboy4u 05/01/19 02:02:44 PM
#739   Can we please stop playing around and get Juschilln 05/01/19 09:55:50 AM
#738   Squeeze'em boys...shorty is trying to cover! Weeee 420man 05/01/19 09:39:12 AM
#737   CTRV up today ..33% since last mentioned Blutribe 05/01/19 09:34:07 AM
#736   I'm ready . . . Juschilln 05/01/19 09:28:19 AM
#735   Break .14 and its game on! 420man 05/01/19 09:05:49 AM
#734   Funding round was to close on Monday. Tutes 420man 05/01/19 07:28:29 AM
#733   What is the consensus of buying more? Newbuyr 04/30/19 10:48:30 PM
#732   Gonna hit .21 fast! JMO 420man 04/30/19 07:01:20 PM
#731   * * $CTRV Video Chart 04-30-2019 * * ClayTrader 04/30/19 05:07:57 PM
#730   Thanks!! Juschilln 04/30/19 12:11:18 PM
#729   NICE !!, back to you :) Blutribe 04/30/19 10:40:43 AM
#728   NICE! Juschilln 04/30/19 10:39:14 AM
#727   working out great..up in premkt..are you short?...news..ContraVir Pharmac Blutribe 04/30/19 09:13:00 AM
#726   How's that working out for you?? Juschilln 04/30/19 08:57:09 AM
#725   News: $CTRV ContraVir Pharmaceuticals to Present at the whytestocks 04/29/19 03:31:00 PM
#724   Do you think Tutes want retail owning shares 420man 04/26/19 07:54:54 PM
#723   They have already done one RS which resulted Newbuyr 04/26/19 07:23:22 PM
#722   https://ih.advfn.com/stock-market/NASDAQ/contravir-pharmaceuticals-inc-CTRV/stock-news/79779206/pros 420man 04/26/19 05:16:06 PM
#721   This company is a scam imo PStockPickz 04/26/19 03:45:10 PM