Vardenafil Hydrochloride

In ED patients that do not respond to PDE5i monotherapy ~30-40% of ED patients do not respond to PDE5i treatment Data from this Phase 2 clinical study is expected by end of calendar year 2024 Published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i monotherapy expected to start in the 1st half of calendar year 2025 CRANBURY, N.J., June 20, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced the initiation of a Phase 2 clinical study of bremelanotide (BMT), a melanocortin 4 receptor (MC4R), co-administered with a phosphodiesterase 5 inhibitor (PDE5i), for the treatment of erectile dysfunction (ED) in patients that do not respond to PDE5i monotherapy. Topline data from the Phase 2 clinical study is expected by the end of calendar year 2024. "Approximately 30-40% of ED patients exhibit little or no response to PDE5i monotherapy, such as Viagra, Cialis, and Levitra," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "These PDE5i monotherapy drugs account for over $4 billion of annual sales, yet PDE5i monotherapy does not work for a significant portion of ED patients. This represents a substantial unmet medical need for more effective ED treatments. Based on our clinical data and mechanisms of action research, we believe that BMT combined with a PDE5i is synergistic and will be a clinically meaningful ED treatment for non-responders to current PDE5i monotherapy." The Phase 2 clinical trial is designed to enroll approximately 50 patients to be treated with BMT co-administered with a PDE5i in an open-label, dose escalation study treating men with ED who are considered non-responders to PDE5i monotherapy treatment. The clinical study is being conducted under an investigator-sponsored Investigational New Drug (IND) and has Food and Drug Administration (FDA) clearance and Institutional Review Board (IRB) approval. The study's primary objective is to assess the safety and efficacy of BMT co-administered with a PDE5i for the treatment of ED in males who have not adequately responded to prior PDE5i monotherapy. "ED has become more prominent over the last several decades, especially in younger adults, and represents a mounting health concern causing a significant effect on men's quality of life," said Jed Kaminetsky, MD, FACS, Urologist, Director of Research, Integrated Medical Professionals, a Division of Solaris Health and the clinical study lead investigator. "Many patients in my practice are seeking better results from their ED treatment. Men with more severe ED do not respond as well using a PDE5i and have limited non-surgical options. I have used bremelanotide in my practice for men with ED. I believe the combination of bremelanotide with a PDE5i could potentially be an effective treatment option for the PDE5i non-responders suffering from ED." Palatin has conducted multiple clinical studies of monotherapy BMT and combination therapy BMT plus a PDE5i in men with ED and observed statistically significant and clinically meaningful effects on improving erectile function. In addition, sub-cutaneous bremelanotide 1.75 mg (Vyleesi®) is approved by the FDA for the treatment of hypoactive sexual desire disorder (HSDD) in pre-menopausal women and has demonstrated an increase in sexual desire and decrease in distress associated with low desire. Palatin has developed a new co-formulation of bremelanotide and a PDE5i which can be administered as a single injection. An IND for this novel co-formulation for the treatment of ED is expected to be filed with the FDA later this calendar year and a potential Phase 3 clinical study in ED patients who do not respond to PDE5i monotherapy is expected to start in the first half of calendar year 2025. About Erectile Dysfunction (ED) Erectile dysfunction is the consistent inability to attain and maintain an erection sufficient for sexual intercourse and affects an estimated 30 million men in the United States, according to the Centers for Disease Control and Prevention. Approximately 30-40% of men are non-responsive to standard therapies with phosphodiesterase-5 inhibitors (PDE5i) such as sildenafil (Viagra®), vardenafil (Levitra®) and tadalafil (Cialis®). There are limited therapeutic options for ED patients non-responsive to PDE5i therapy, including alprostadil for direct penis injection or urethral suppositories, surgical penile implants and various devices. About Palatin Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. To learn more about Palatin, please visit us on and follow us on Twitter at @PalatinTech. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates 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. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory agencies and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release. Palatin Technologies® is a registered trademark of Palatin Technologies, Inc. SOURCE Palatin Technologies, Inc.

Patent has already been issued in other major markets including the U.S. PETACH TIKVA, Israel--(BUSINESS WIRE)-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the European Patent Office for its patent application titled “An A3 Adenosine Receptor Ligands For Use in Treatment of a Sexual Dysfunction”. This invention addresses the use of the CF602 drug candidate as an oral or topical drug for patients such as diabetics, who suffer from erectile dysfunction, and cannot use the current drugs on the market. While oral phosphodiesterase type 5 (PDE5) inhibitors are the current standard of care for erectile dysfunction (ED), with brands including Viagra, Cialis, Levitra, and Stendra, an estimated 30% to 35% of ED patients are non-responders, and these drugs can be contraindicated for people living with diabetes. Can-Fite recently published an article in Andrologia, suggesting that CF602 could potentially offer an alternative to the current drugs on market. A full erectile recovery was achieved following a single dose of CF602 with restored muscle collagen ratio and endothelial cell function. Can-Fite’s CF602, an allosteric modulator of the A3 adenosine receptor (A3AR), applied topically or orally in a diabetic rat model, resulted in increased arterial blood flow and significant dose-dependent improvements in intracavernosal pressure (ICM), smooth muscle/collagen ratio, vascular endothelial growth factor and endothelial nitric oxide synthase. treatment to PDE5 inhibitors, particularly to PDE5 non-responders and diabetics. “This additional European patent for erectile dysfunction adds to our growing IP estate for this high-value indication of the CF602 drug candidate. We believe our strong and broad IP, together with the pre-clinical positive data position it as a promising candidate for further development for the treatment of sexual dysfunction,” stated Motti Farbstein, Can-Fite CEO. The Erectile Dysfunction market is expected to reach approximately $6.6 billion by 2030, according to Market Research Future. About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety pro the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment metabolic dysfunction-associated steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . Forward-Looking Statements This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. View source version on businesswire.com: Contacts Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114 Source: Can-Fite BioPharma Ltd. View this news release online at: