Tags Posts tagged with "$CARA"

$CARA

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Marijuana Stocks Cannabis Stocks

A legal cannabis movement is sweeping the United States and currently, 29 states and the District of Columbia have legalized medical marijuana and eight states have legalized recreational marijuana.

Although recent studies have shown that cannabis has medical benefits, the DEA and FDA still have it classified as a Schedule I substance. The Schedule I category is reserved for substances that have the highest potential for abuse, that have no accepted medical use and even under medical supervision cannot be used safely.

Although researchers are beginning to learn about the medical benefits associated with cannabis, they have not even scratched the surface. The cannabis industry is the fastest growing industry in the world. After spending several years researching cannabis and developing products, companies are just beginning to realize the fruits of their efforts.

Biotech Beneficiaries

The biotech sector will be one of the greatest beneficiaries of the legal cannabis movement and we expect this market to see incremental growth over the next decade.

Cannabis continues to improve daily life for millions of people all over the globe and this multi-billion-dollar opportunity is still in its infancy. The biotech sector of the cannabis industry is comprised of some of the best capitalized and most mature public companies and we have identified five companies for investors to monitor.

IGC: A Stock to Watch After Coming Off its Highs

India Globalization Capital (IGC) is one of the few cannabis-focused companies that trade on the New York Stock Exchange (NYSE) and earlier this month, the company entered a definitive license agreement with the University of South Florida (USF). Under the agreement, IGC is the exclusive licensee of the U.S. patent filing entitled, THC as a Potential Therapeutic Agent for Alzheimer’s Disease.

This is an important development and milestone for the company as it works toward the development of a potential cannabis-based blockbuster treatment for America’s most expensive disease, Alzheimer’s disease.

IGC received a muted reaction from the market and we see upside to current levels after this milestone. We are favorable on IGC’s recent updates as it has pivoted fully into the biotech cannabis sector and continue to monitor developments around the company’s cannabinoid-based therapies.

Insys Receives a Positive Response to Management Additions

Insys Therapeutics (INSY) continues to trade higher after the company announced the addition of four pharmaceutical industry veterans to its management team. These additions help remove some of the market’s concerns pertaining to the strength of its management team and we see further upside from current levels.

we view Insys as an acquisition candidate and expect to see the company acquired this year. In July 2016, INSY announced that the FDA approved Syndros, an orally administered liquid formulation of the pharmaceutical cannabinoid Dronabinol, a pharmaceutical version of THC. At the time of this announcement, INSY said that Syndros is awaiting scheduling by the DEA.

GW Pharma: An Industry Leader

GW Pharmaceuticals (GWPH) has come off its recent lows and the shares are trading near $105 after falling below $93 earlier this month. GW is an industry leader and the company has several catalysts occurring in the second half of this year.

GW is changing the landscape of the biotech industry and the company already sells a cannabis-derived treatment for multiple sclerosis is 27 countries. GW is a company that investors need to watch as it continues to execute on its pipeline and create value for shareholders.

Nemus Advances its THC Pro-Drug

Today, Nemus Bioscience (NMUS) announced that tetrahydrocannabinol (THC) derived from NB1111, a proprietary pro-drug of THC, achieved significant tissue concentrations in multiple compartments of the eye that are correlated with the lowering of IOP in a normotensive ocular animal model.

The abstract, Intraocular pressure lowering efficacy of NB1111 in a normotensive rabbit model expands on previously reported data by showing that the product safely penetrated multiple ocular chambers and concentrated in key tissues that help regulate intraocular pressure.

Nemus and the University of Mississippi have also collaborated on developing an analogue of CBD into an eye drop formulation called NB2222. The company plans to submit an abstract to an upcoming scientific meeting to present data on the NB2222 program.

We are favorable on this development and view Nemus’ relationship with the University of Mississippi to be a unique and differentiating factor. The shares are trading at $0.28 and this is a company investors should watch.

Cara Surges 10% on Positive Data

Cara Therapeutics (CARA) rallied more than 10% yesterday after the company announced the completion of a pre-specified interim conditional power analysis of its adaptive Phase 3 trial of I.V. CR845. The trial will continue to test two doses of CR845 against a placebo in up to 450 patients undergoing abdominal surgery. The Independent Data Monitoring Committee (IDMC) reviewed available safety information and confirmed that both doses of CR845 were well tolerated with no significant changes in the monitored safety parameters.

The primary efficacy measure is the Change in Pain Intensity over the 24-hour postoperative period using the patient-reported Numeric Rating Scale score collected at pre-specified time points through 24 hours. Postoperative nausea and vomiting will be evaluated as a secondary efficacy measure.

Although CARA has not advanced any of its cannabis initiatives, we continue to monitor the shares closely. Although we do not consider CARA to be a cannabis biotech stock, we continue to monitor the shares due to the potential it has to enter the sector.

Authored By: Jason Spatafora

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The biotech sector will be one of the greatest beneficiaries of the global cannabis movement and is comprised of some of the most mature and best capitalized companies.

The Nasdaq was the worst performing exchange yesterday and biotech cannabis-focused firms traded lower on average. Although we continue to be bullish on this sub-sector of the cannabis industry, it is also the one that would be most impacted by a correction in the market.

This sector is comprised of some of most attractive long-term companies. We think recent weakness has created opportunity and we want to highlight five cannabis stocks every investor should be watching.

Insys Therapeutics (INSY) traded in a very volatile range after reporting its fourth quarter and full year financial results yesterday. Insys opened down almost 5% and the shares traded as low as $10.01 before finding support. INSY bounced off these lows and the shares ended the day up 2.2%. INSY is at $10.75 and Technical420 plans to average down and add to its position if the shares trade below $10. The shares are trading well below its average Wall Street price target (more than 60% upside to average price target). One of the main reasons why we are favorable on Insys is because we view the company as an acquisition candidate due to its valuable intellectual property and relatively cheap valuation.
Corbus Pharmaceuticals (CRBP) gave up all its gains from Monday and the shares are trading at $8.05 after a 2.4% move lower on weak volume. We continue to monitor CRBP from the sidelines after exiting our position within hours of entering. We are on the sidelines due to the misleading reports, the increased volatility, and the potential for the market to dip lower in the near term.
Cara Therapeutics (CARA) was under pressure yesterday and the shares are trading below the pricing of its recently announced financing. Technical420 remains favorable on Cara Therapeutics and see significant upside to current levels. The shares are trading at $17.92 after a 2.5% move lower and we plan to add to our position on continued weakness. Cara plans to use the proceeds from its $80 million raise to fund clinical and R&D activities, including the completion of the Phase 3 program in uremic pruritus, two Phase 3 trials in acute pain and a Phase 2b trial in osteoarthritis pain. We will keep you updated on how the shares trade today.
GW Pharmaceutical (GWPH) edged lower on light volume yesterday and the shares are currently trading below its 20 and 50-day moving average. GWPH has fallen 8% in the last month and we view the shares as an attractive long-term opportunity at current levels. GW has one of the deepest pipelines of products in advanced stages of FDA testing. The company also has the best Wall Street coverage and has received buy ratings from Goldman Sachs, Merrill Lynch, and Morgan Stanley. We view GW as an acquisition candidate and Goldman Sachs estimated a $390 a share acquisition price if that was to occur. From the filing of a New Drug Application to multiple Phase 3 Clinical trials, GW Pharma is an event-driven story that has many potential catalysts. We plan to hold and add to our position on continued weakness.
Zynerba Pharmaceuticals (ZYNE) continues to be one of the most attractive cannabis biotech investment opportunities due to the relatively cheap valuation, its high-quality pipeline of products, the number of upcoming catalysts, and its favorable and improving Wall Street coverage. In late March, H.C. Wainwright raised Zynerba’s price target to $30 from $22. The average price target on shares of Zynerba is north of $30 and offers more than 50% upside to current levels.

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WASHINGTON — The administration of “Yes We Can” is now the administration of “No We Won’t,” in a ruling that keep marijuana as a schedule 1 drug. No one at Marijuana Stocks is surprised by this ruling from the administration via the lengthy statement from the Drug Enforcement Administration (DEA). Again the Cannabis advocates, activists & patients in need of the properties associated with Medical Marijuana were given some crumbs in true “Hunger Games” Style. As of today’s ruling by the DEA the study of cannabis will be expanded in order to ascertain the potential medical benefits of cannabinoids. Marijuana will continue to be on the list of the most dangerous drugs, regardless of growing support for legalization and more states changing their laws to have some form of medical marijuana or recreational marijuana on the books.

“By punting the reclassification of marijuana debate the DEA exposes themselves to the utter hypocrisy of our classification system. Consider Cocaine and OxyContin are class 2 drugs and are far more ruinous to the people that use and abuse them, yet cannabis which can’t kill you is a class 1 drug which by definition means there are no medical benefits and highly addictive.” Said an agency source under the condition of anonymity.
The Health and Human Services Department was so bold today as to double down on the illogical argument on marijuana by saying cannabis “has a high potential for abuse” and “no accepted medical use.”
A statement of that nature exposes some problems with that argument as well as showing who is potentially to blame for the bureaucracy surrounding these kind of government rulings. Let’s examine this statement and try and draw some conclusions on our own.

First, if marijuana has no medical properties or potential benefits why are BigPharma companies spending hundreds of millions of dollars in research and development to study marijuana and create drugs for patients? Abbvie Inc (ABBV) has had a cannabis related drug it has marketed since 1985 for example called Marinol (Dronabinol Extract) which is an appetite stimulant used by cancer patients. INSYS Therapeutics Inc (INSY) was just given FDA approval for its orally administered drug called Syndros last month which is similar to ABBV’s appetite drug. GW Pharmaceuticals (GWPH) has a drug called Epidiolex for people suffering from seizures, they are also creating their own strains of cannabis for individual targeted Cannabinoids. Any person that has ever used medical marijuana for example knows that one of its side effects is hunger or the “munchies.” Why try and synthesize a drug when nature and thousands of years of use has produced the same result you ask? Money from prescription drugs, money from speculation on the public company creating these drugs and ridiculous ways to capitalize from the insurance that pays for it all. The reality is that cannabis is essentially a weed that grows all over the world and the pharmaceutical industry would lose potentially hundreds of billions of dollars if cannabis was federally legal. Which leads me to point two in exposing the bureaucracy tied to Big Pharma.

So how do the lawmakers in the United States and agencies like the DEA come to these irrational conclusions that lack all common sense? Lobbyists on K Street in DC for starters. Given medical marijuana’s position as a cheaper, safer alternative to pharmaceutical products, pharmaceutical companies stand to lose a significant chunk of market share if marijuana legalization were to pass. BigPhRMA is universally recognized as marijuana’s biggest financial competitor, with drug manufacturers giving a whopping $21.8 million to a myriad of federal candidates and committees, as well as political parties during election times. In 2013 alone, Big Pharma spent approximately $18 million solely on lobbying, according to OpenSecrets. While easily one of the biggest contenders to the marijuana industry, Big Pharma was hit with a crucial turning point, a survey of 473 adult therapeutic cannabis users, conducted by the Centre for Addictions Research of BC, found that 87% of respondents gave up prescription medications, alcohol, or other drugs in favor of cannabis.

Other Lobbies that are fighting relentlessly against cannabis are private prison corporations as well as the alcohol & tobacco industry. For mor info on that here’s an article on the top five lobby’s.

In the end officials need to get elected and no one wants to piss off their donors, grassroots organizations like Norml or the Marijuana Policy Project are fighting a war against opponents that have unlimited resources. Even so the expansion of study does crack the door open for the industry and in our opinion prohibition will eventually end. Once the government and big business set up the infrastructure to capitalize on cannabis they will demand their piece of the pie, which has an estimated black market value of $50,000,000,000 and a legal US market estimated at $6,000,000,000. That might be a scary thought, but there will always be artisanal cannabis for the masses and the best growers in the industry don’t need to become sellouts which is positive to us.
Here is the statement from the DEA today. Share this article, Tweet it, Facebook it, email it to your friends and congressman. Everyone must do their part or the elected officials we put in office will continue to vote against our collective interests.

Regards,

@WolfofWeedSt

DEA

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    MarijuanaStocks.com asked FBEC Worldwide Inc’s (FBEC) chief scientist Linda Strauss an adjunct professor at UC San Diego and Co-Founder of G Randel & Sons a development company that specializes in CBD based R&D for product creation her thoughts on INSY from a drug standpoint. “Looking at the market’s reaction to Insy Therapeutics’ (INSY) announcement two weeks ago that the U.S. Food and Drug Administration (FDA) has approved its dronabinol oral solution, SyndrosTM, you would think this was a breakthrough treatment. However, it is not, but that doesn’t make it any less important an announcement. SyndrosTM is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, which is a pharmaceutical version of tetrahydrocannabinol (“THC”), one of the main active ingredients in cannabis. Dronabinol has been on the market since 1985, marketed by AbbVie ($ABBV) as Marinol. Marinol was developed and approved for the treatment of nausea and vomiting associated with cancer chemotherapy inpatients that had failed to respond adequately to conventional antiemetic treatments. SyndrosTM is only the second pharmaceutical cannabinoid to win approval by the FDA for marketing in the United States. Unlike Marinol, which is manufactured as a capsule containing THC in sesame oil, SyndrosTM is an orally administered liquid formulation that has a quicker onset and can be self­titrated, meaning the patient can use as much or as little as they need by making small adjustments in the amount they take.

    SyndrosTM carries the same risk of side effects as Marinol including psychiatric and cognitive effects and impaired mental and/or physical abilities. There are only a limited number of patients who would stand to benefit from a product like SyndrosTM. Patients currently taking Marinol are the most likely to benefit by switching to SyndrosTM as they would be able to self­titrate their own dosage and improved bioavailability. Ultimately this is a good sign that the FDA is willing to approve new cannabinoid drugs that meet their high standards for approval including those derived from the cannabis plant itself rather than it being derived synthetically.”

    All of this bodes well for the big board pharma companies looking to synthesize specific parts of the cannabis plants for drug treatments as a ruling from the Drug Enforcement Administration is expected to happen within the next 6 month. The referenced ruling is in regards to the possible rescheduling of Cannabis. Marijuana is currently listed as a schedule 1 drug alongside LSD, Crystal Meth, Heroin, MDMA (ecstasy) and Mescaline (peyote), despite the fact that cannabis has never caused a person to die from overdose. Advocates have long felt that the demonization of marijuana and lack of study has been more about politics than common sense measures. If cannabis is rescheduled to class 2, 3 or removed entirely the entire industry will expand rapidly. The first companies to benefit will be, ironically, in the sector that has lobbied against cannabis so ardently; Big Pharma. These Biotech companies want a schedule 2 classification which would expand the study, while everyone would settle for 3 or complete removal.

    Michael Berger from Technical420.com stated “The rescheduling of cannabis will serve as a major catalyst for the biotech industry and those companies that have cannabis related drugs in their drug trial pipeline will bring in new investors that were once gun shy about Marijuana Stocks due to the current classification.” He went on to tell MarijuanaStocks.com that “current speculation from industry insiders is that companies like INSY, CARA, ZYNE GWPH could all be acquisition targets from some of the Big Pharma super powers.”

    There’s no doubt in our mind that this would be an event driven catalyst that the Marijuana sector thrives on, enhancing the overall public & private markets. We can only hope that common sense and logic will win out there by opening the door to full legalization.

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    Cara Therapeutics Initiates Phase 3 Program for I.V. CR845 in Acute Postoperative Pain

    SHELTON, Conn., Sept. 9, 2015 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced the initiation of its Phase 3 program for the intravenous (I.V.) formulation of CR845 in postoperative pain with the dosing of the first subjects in an adaptive pivotal trial in patients undergoing a range of abdominal surgeries.

    “The initiation of this pivotal trial is an important step toward defining the clinical utility of I.V. CR845 for the treatment of acute postoperative pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “Following our successful Phase 2 trials with I.V. CR845 in patients undergoing laparoscopic hysterectomy and bunionectomy, we believe that positive results from this general abdominal surgery trial would continue to build a strong foundation for our overall Phase 3 program and ultimate planned submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration.”

    The CLIN3001 trial is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients. The trial will enroll up to 600 patients undergoing either hysterectomy, prostatectomy, hemi-colectomy or ventral hernia at 30 clinical sites within the U.S.

    Three dose levels of I.V. CR845 (1.0, 2.0 and 5.0 ug/kg I.V.) will be compared to placebo. The primary efficacy measure is the Change in Pain Intensity over the 24-hour postoperative period (AUC-24) using the patient-reported Numeric Rating Scale (NRS) score collected at pre-specified time points through 24 hours. Postoperative nausea and vomiting (PONV) will be evaluated as a secondary efficacy measure. The impact of I.V. CR845 treatment on inflammatory biomarkers will also be explored. Top-line data are expected in the first half of 2016.

    About CR845

    CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in both pain intensity and opioid-related side effects. In more than 440 subjects dosed to date, I.V. CR845 was observed to be well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. In Q3’15, Cara initiated a Phase 2 trial of an oral tablet formulation of CR845, for the treatment of osteoarthritis (OA).

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated activity in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

    Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing of top-line results from the I.V. CR845 adaptive pivotal trial, the results of the trial and the potential clinical utility of I.V. CR845 and the ultimate submission of an NDA for I.V. CR845. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, the Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:
    CORPORATE CONTACT:
    Derek Chalmers, Ph.D., D.Sc.
    President & CEO
    Cara Therapeutics, Inc.
    203-567-1500
    MEDIA CONTACT:
    Annie Starr
    6 Degrees
    973-415-8838
    astarr@6degreespr.com
    INVESTOR CONTACT:
    Jesse Baumgartner
    Stern Investor Relations, Inc.
    212-362-1200
    Jesse@sternir.com

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    Cara Therapeutics Issued Additional U.S. Patent Covering the Expanded Use of Kappa Opioid Receptor Agonist CR845 and Analogs for the Treatment and Prevention of Pain-Related Conditions

    SHELTON, Conn., Feb. 10, 2015 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced the issuance of U.S. Patent No. 8,951,970 with claims covering the use of its lead clinical compound, CR845, and related compounds of this chemical class for the treatment and prevention of a broad range of pain-related conditions.

    The issued patent includes claims directed to the use of CR845 in treating and preventing pain associated with arthritis, kidney stones, uterine cramping, diabetes, and gastrointestinal conditions such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). Additional conditions covered by the claims include pain due to viral infections, such as post-herpetic neuralgia, chemotherapy-induced pain and neuropathic pain.

    “We are pleased with the issuance of these latest U.S. patent claims, which provide a further layer of intellectual property protection when combined with our previously issued composition of matter claims for CR845 and its related analogs,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “The breadth of our issued patent claims reflects the broad potential and clinical utility of CR845 in treating a spectrum of conditions associated with pain and chronic pruritus.”

    Patent No. 8,951,970 is the Company’s latest in a series of U.S. patents covering CR845, its analogs and their clinical uses. Cara’s issued U.S. patents, Nos. 7,402,564 and 7,727,963, include claims to CR845 and its uses for general pain and pruritus. Pruritus is a debilitating disorder associated with several medical conditions including renal disease, chronic liver disease, endocrine disorders and dermatological conditions. Cara Therapeutics owns patents with similar claims to CR845 and its analogs in over 30 European countries, as well as Australia, Canada, China, Japan, and Russia.

    About CR845

    CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and uremic pruritus. In multiple randomized, double blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. In a human abuse liability trial, I.V. CR845 met the primary endpoint showing highly statistically significant reductions (p < 0.0001) in scores for “drug liking,” as well as “feeling high,” “overall liking,” and “take drug again” when compared to I.V. pentazocine, a Schedule IV opioid analgesic.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

    Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for the Company’s Phase 2 trial of I.V. CR845 in dialysis patients experiencing uremic pruritus, the design and the potential for successful results of the trial, the timing of the reporting of the topline results of the trial, as well as the potential future regulatory and development milestones for the Company’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:
    CORPORATE CONTACT:
    Derek Chalmers, Ph.D., D.Sc.
    President & CEO
    Cara Therapeutics, Inc.
    203-567-1500
    MEDIA CONTACT:
    Annie Starr
    6 Degrees
    973-415-8838
    astarr@6degreespr.com
    INVESTOR CONTACT:
    Jesse Baumgartner
    Stern Investor Relations, Inc.
    212-362-1200
    Jesse@sternir.com

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    Cara Therapeutics to Webcast Presentation at 17th Annual BIO CEO & Investor Conference

    SHELTON, Conn., Feb. 2, 2015 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Dr. Derek Chalmers, President and CEO, will present a company overview at the 17th Annual BIO CEO & Investor Conference on Monday, February 9, 2015, at 8:30 a.m. ET in New York City.

    A live webcast of the presentation can be accessed under “Events and Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com. An archived webcast recording will be available on the Cara website for approximately 30 days.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

    Contact:
    INVESTOR CONTACT:
    Jesse Baumgartner
    Stern Investor Relations, Inc.
    212-362-1200
    Jesse@sternir.com
    MEDIA CONTACT:
    Annie Starr
    6 Degrees
    973-415-8838
    astarr@6degreespr.com

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    Cara Therapeutics Announces Addition to the NASDAQ Biotechnology Index

    SHELTON, Conn., Dec. 18, 2014 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI). The addition will become effective at market open on Monday, December 22, 2014.

    The NASDAQ Biotechnology Index is designed to track the performance of a set of NASDAQ-listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The NASDAQ Biotechnology Index is re-ranked annually. The NASDAQ Biotechnology Index is the basis for the iShares NASDAQ Biotechnology Index Fund (IBB), which seeks investment results that correspond generally to the price and yield performance, before fees and expenses, of the NASDAQ Biotechnology Index. In addition, options based on the iShares NASDAQ Biotechnology Index Fund trade on various exchanges. For more information about the NASDAQ Biotechnology Index visit www.nasdaq.com.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

    Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for the inclusion of the Company’s common stock in the NASDAQ Biotechnology Index, as well as the potential future regulatory and development milestones for the Company’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:
    CORPORATE CONTACT:
    Derek Chalmers, Ph.D., D.Sc.
    President & CEO
    Cara Therapeutics, Inc.
    203-567-1500
    MEDIA CONTACT:
    Annie Starr
    6 Degrees
    973-415-8838
    astarr@6degreespr.com
    INVESTOR CONTACT:
    Jesse Baumgartner
    Stern Investor Relations, Inc.
    212-362-1200
    Jesse@sternir.com

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    Cara Therapeutics Reports Positive Top-Line Data From Phase 1b Trial of I.V. CR845 in Dialysis Patients

    • I.V. CR845 observed to be safe, well tolerated, and to exhibit dose linear exposure in patients undergoing dialysis
    • Effective itch reduction seen in subgroup of patients with uremic pruritus
    • Phase 2 trial in dialysis patients with uremic pruritus underway

    SHELTON, Conn., Dec. 17, 2014 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced the successful completion of a Phase 1b trial of an intravenous (I.V.) formulation of CR845 in dialysis patients. In the repeat dosing of I.V. CR845 over one week was observed to be safe and well-tolerated across a five-fold dose range, and the trial established a dosing regimen for the ongoing Phase 2 trial in dialysis patients with uremic pruritus. The company expects to report top-line data from this trial in the first half of 2015.

    “The completion of this Phase 1b trial and initiation of the Phase 2 study in uremic pruritus is an important step in establishing the potential clinical utility of CR845 in this area of significant unmet medical need,” said Frederique Menzaghi, Ph.D., Vice President of Research and Development at Cara Therapeutics. “We are particularly encouraged that preliminary data from this trial indicate that CR845 effectively reduced “worst itching” scores in those subjects who entered the study with ongoing moderate-to-severe uremic pruritus. We look forward to reporting top-line data from our Phase 2 trial in the first half of 2015.”

    There are currently no approved therapeutics in the United States for uremic pruritus, an intractable type of itch that is generally resistant to conventional treatments, and diminishes the quality of life for almost half of all kidney dialysis patients.

    The Phase 1b trial was a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and pharmacokinetics (PK) of I.V. CR845 in 24 hemodialysis patients. I.V. CR845 was administered as a bolus dose (0.5 ug-2.5ug/kg) after each dialysis session up to three times a week (t.i.w.). Pharmacokinetic analysis indicated that I.V. CR845 exhibited dose linear increases in Cmax and AUC with an approximate 10-fold increase in AUC across doses in these dialysis patients compared to normal subjects.

    I.V. CR845 was observed to be safe and well tolerated over the one-week dosing period with no serious adverse events (AEs) reported. The most common AEs were transient facial tingling and headache. Although uremic pruritus was not an inclusion criterion for randomization, three subjects entered the trial with “worst itching” baseline scores in the moderate-to-severe range, >4.0 on a 10.0 point visual analog scale (VAS). All three subjects received t.i.w. dosing of I.V. CR845 (two subjects at 1ug/kg, one at 2.5ug/kg) and ended the one-week dosing period with reported “worst itching” scores of 1.0 or less.

    “We are very encouraged that our clinical data to date in hemodialysis patients indicate that CR845 may provide a novel therapeutic approach for patients suffering the burden of chronic pruritus associated with chronic kidney disease,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “The ability to broaden the potential clinical utility of CR845 beyond pain into the spectrum of conditions associated with chronic pruritus is a significant opportunity, and we look forward to seeing the data from this additional set of patients with uremic pruritus next year.”

    The ongoing Phase 2 trial will measure the efficacy of I.V. CR845 compared to placebo in reducing the intensity of itch in dialysis patients with baseline “worst itching” scores of 4.0 or greater over a two-week dosing period. The primary endpoint of the study will be the change from baseline in the average “worst itching” scores during the second week of treatment, as recorded on a VAS. Secondary endpoints will focus on quality of life measures associated with pruritus burden using a series of previously validated self-assessment scales. The study will enroll a total of 60 dialysis patients at multiple sites in the U.S.

    About CR845

    CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and uremic pruritus. In multiple randomized, double blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In over 400 subjects dosed to date, I.V. CR845 was observed to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. In a human abuse liability trial, I.V. CR845 met the primary endpoint showing highly statistically significant reductions (p < 0.0001) in scores for “drug liking,” as well as “feeling high,” “overall liking,” and “take drug again” when compared to I.V. pentazocine, a Schedule IV opioid analgesic.

    About Cara Therapeutics

    Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

    Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for reporting results of the Company’s Phase 2 trial of I.V. CR845 in dialysis patients experiencing uremic pruritus, the expected level of patient enrollment and the potential for successful results of the trial, the timing of the reporting of the topline results of the trial, as well as the potential future regulatory and development milestones for the Company’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Contact:
    CORPORATE CONTACT:
    Derek Chalmers, Ph.D., D.Sc.
    President & CEO
    Cara Therapeutics, Inc.
    203-567-1500
    MEDIA CONTACT:
    Annie Starr
    6 Degrees
    973-415-8838
    astarr@6degreespr.com
    INVESTOR CONTACT:
    Jesse Baumgartner
    Stern Investor Relations, Inc.
    212-362-1200
    Jesse@sternir.com

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