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PALATIN TECH INC (AMEX: PTN)

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  1. [verwijderd] 12 augustus 2009 15:05

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    Aug. 11, 2009 Market Close: $0.33

    Pre-Market
    Last: $0.47
    High: $0.59
    Volume: 730,970
    Low: $0.45

    Palatin Technologies, Inc. Reports Positive Bremelanotide Study; Improved Safety Profile with Subcutaneous Administration

    2009-08-12 07:30 ET - News Release

    CRANBURY, N.J., Aug. 12 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. today announced the completion of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without blood pressure side effects. Based on the positive results of this study, Palatin has scheduled a meeting with the U.S. Food and Drug Administration to discuss initiation of a Phase 2B study of subcutaneously administered bremelanotide for ED.

    "This study supports our hypothesis that increases in blood pressure and gastrointestinal events seen with intranasally administered bremelanotide were primarily related to high plasma levels in a subset of patients. We believe this was due to variability in drug uptake with intranasal administration," said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin. "The switch from intranasal to subcutaneous administration appears to address the blood pressure concerns raised by the FDA. Our next step is to put this data in front of the FDA as we prepare to move bremelanotide back into a Phase 2 study later this year."

    Key Results

    In all subjects, subcutaneous administration of bremelanotide resulted in consistent and predictable plasma concentrations at levels known from previous studies to improve erectile function. Other key results include:

    -- No statistically significant difference in mean changes in blood
    pressure was seen in subjects receiving bremelanotide compared to
    placebo.
    -- No clinically or statistically significant difference in the range of
    blood pressure changes was seen in subjects receiving bremelanotide
    compared to placebo.
    -- No subject discontinued participation in the study as a result of
    protocol stopping rules based on blood pressure changes.
    -- No subject discontinued participation in the study due to nausea.
    -- No difference in the rate of vomiting observed between subjects
    receiving bremelanotide compared to placebo (one in each group).

    Study Design

    The two week randomized, double-blind, placebo-controlled Phase 1 study in 54 subjects (27 bremelanotide, 27 placebo) measured blood pressure at baseline and before and after each of 45 doses of bremelanotide or placebo administered subcutaneously. The dose administered was selected to result in a plasma level of bremelanotide known, from previous studies, to be efficacious for improving erectile function. Continuous ambulatory blood pressure data was also collected for the first 48 hours after the initial dose in all subjects.

    Commercial Opportunity

    "We are excited by the commercial opportunity for bremelanotide. About 35% of patients with ED do not respond to approved oral therapies, and with limited treatment options these patients are ideal candidates for subcutaneous bremelanotide," stated Carl Spana, Ph.D., President and CEO of Palatin. "We have an additional opportunity with FSD, which represents a large market opportunity with no FDA approved drugs."

    About Bremelanotide

    Bremelanotide, a synthetic peptide developed and solely owned by Palatin, is believed to act through activation of melanocortin receptors in the central nervous system. Intranasal formulations of bremelanotide have been extensively studied, including Phase 2B studies for ED in both non-diabetic and diabetic patients and Phase 2A studies for FSD in both pre- and post-menopausal women.

    About Erectile Dysfunction (ED)

    ED is the consistent inability to attain and maintain an erection sufficient for sexual intercourse. The condition is correlated with increasing age, cardiovascular disease, hypertension, diabetes, hyperlipidemia and smoking. In addition, certain prescription drugs and psychogenic issues may contribute to ED. It is estimated that some degree of ED affects half of all men over the age of 40 and that 150 million men worldwide suffer from ED. Up to 35% of men with ED are non-responsive to standard therapies with phosphodiesterase-5 inhibitors, representing an estimated market of $500 to $600 million per year.

    About Female Sexual Dysfunction (FSD)

    FSD includes four disorders, hypoactive sexual desire disorder, female sexual arousal disorder, dyspareunia and anorgasmia. To establish a diagnosis of FSD, these syndromes must be associated with personal distress, as determined by the affected woman. A February 10, 1999 study published in the Journal of the American Medical Association, titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that approximately 43% of postmenopausal women suffer from some form of FSD. There are no drugs in the United States approved for FSD indications.

    About Palatin Technologies, Inc.

    Palatin Technologies, Inc. is a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin Technologies' website at www.palatin.com.

    Forward-looking Statements

    Statements about future expectations of Palatin Technologies, Inc., including statements about its development programs, proposed indications for its product candidates, clinical activities, marketing collaborations, and all other statements in this document other than historical facts, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Palatin's actual results may differ materially from those discussed in the forward-looking statements for various reasons, including, but not limited to Palatin's ability to fund development of its technology, ability to establish and successfully complete clinical trials and pre-clinical studies and the results of those trials and studies, dependence on its partners for certain development activities, need for regulatory approvals and commercial acceptance of its products, ability to protect its intellectual property, and other factors discussed in the Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.

    SOURCE Palatin Technologies, Inc.

    Palatin Technologies, Inc.

    CONTACT: Investor Inquiries, Stephen T. Wills, CPA, MST, EVP-Operations -
    Chief Financial Officer, +1-609-495-2200, info@palatin.com, or Media
    Inquiries, Susan Neath, Burns McClellan, +1-212-213-0006,
    sneath@burnsmc.com, both of Palatin Technologies

    Web site: www.palatin.com/

    www.stockwatch.com/newsit
  3. [verwijderd] 7 december 2009 17:56

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    Palatin Technologies gets US patent for heart failure drug candidate
    Monday, December 07, 2009 15:00 IST
    Cranbury, New Jersey

    Palatin Technologies, Inc announced that the US Patent and Trademark Office has issued US Patent No. 7,622,440, titled 'Cyclic Natriuretic Peptide Constructs'. The claims in the issued patent cover a family of cyclic compounds that bind to natriuretic peptide receptor A(NPRA), including PL-3994, Palatin’s lead heart failure drug candidate.

    “Our natriuretic compounds, including PL-3994, address significant unmet medical needs,” said Trevor Hallam, Palatin’s executive vice president – Research and Development. “These are the only reported compounds that bind to NPRA and have extended half-lives and pharmacokinetic properties making daily subcutaneous administration possible. Besides the potential to decrease re-hospitalization rates in patients with heart failure, PL-3994 may also have application in treating resistant hypertension and pulmonary arterial hypertension.”

    PL-3994 and the related family of cyclic compounds were discovered and developed by Palatin scientists and are solely owned by Palatin. In addition to this issued US patent, Palatin has applications pending in selected countries outside the United States and additional US applications covering related compounds.

    Palatin has completed two clinical trials with PL-3994, a phase-1 trial in healthy volunteers and a phase-2a trial in patients with controlled hypertension.

    Palatin Technologies is a biopharmaceutical company focused on discovering and developing targeted, receptor-specific small molecule and peptide therapeutics.

    Wie is bekend met dit aandeel.Chart looks good lijkt mij.

  7. frank2you 27 juni 2010 22:28

    • frank2you

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    Helaas geen piek maar een kwart eraf door een nieuw aangekondigde aandelenemmissie.... dan gaan we maar voor de long run....want die ziet er steeds positiever uit.
  9. Omnius 10 september 2016 15:42

    • Omnius

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    Oud draadje maar eens boven water halen. Phase 3 voor Brem. voor female sexual dysfunction (FSD) is afgerond. Eind deze maand/begin volgende maand worden de resultaten bekend gemaakt.

    www.google.com/finance?q=NYSEMKT%3APT...

    Positieve insider trading:
    www.nasdaq.com/symbol/ptn/insider-trades

    Let op: erg volatiel fonds en ook erg risicovol. Dus veel upside, maar ook veel downside.

    Disclaimer: ik zit long in dit aandeel, met op dit moment nog een kleine min.

    Koers op dit moment: 0.564 USD

  11. Omnius 1 november 2016 23:13

    • Omnius

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    www.streetinsider.com/dr/news.php?id=...

    Palatin Technologies (PTN) Announces Bremelanotide Phase 3 Met co-Primary Endpoints in HSDD

    November 1, 2016 5:00 PM
    Palatin Technologies, Inc. (NYSE: PTN)announced positive, statistically significant top-line results from the Reconnect Studies, its Phase 3 clinical trial program of lead drug candidate bremelanotide. The Reconnect Studies, investigating bremelanotide as an on-demand treatment for premenopausal women diagnosed with hypoactive sexual desire disorder ("HSDD"), met the pre-specified co-primary efficacy endpoints in both Phase 3 clinical trials.

    "We could not be more pleased with the bremelanotide Phase 3 co-primary endpoint results. Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "I am especially grateful to all of the women who volunteered to be a part of these studies. I would also like to thank Palatin's employees and the many consultants and third-parties that contributed to the advancement of bremelanotide."

    Johna D. Lucas, M.D., Chief Medical Officer of Palatin, said, "In Phase 3 trials bremelanotide was used as needed by premenopausal women with HSDD, with a single dose self-administered in anticipation of sexual activity. The Phase 3 studies demonstrated that bremelanotide provided a meaningful benefit for those patients who responded to the drug candidate. We look forward to the opportunity to provide a new and differentiated treatment option to the many women suffering from HSDD."
  16. Omnius 30 november 2016 22:57

    • Omnius

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    Damn ja. Hoop dat het een strategische zet is voor de onderhandelingen, maar ik ben weer terug bij af...
  18. Omnius 13 maart 2017 17:09

    • Omnius

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    0.33 drama de koers van de laatste maanden. Zit er helaas nog dik in. uitzitten maar.
  19. Omnius 19 april 2017 11:54

    • Omnius

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    Dieptepunt lijkt geweest te zijn, vorige week nog rond de 0,30, nu in twee handelsdagen weer naar de 0.41. Verwacht nog verder herstel komende dagen.
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