GSK-2838497A

- The Sik-Kee Au TCM Brain Theory® Assessment for ADHD and ASD (“SKATBT-A3”), which measures the effectiveness of the treatment on the patient’s overall body and neurodevelopmental conditions, showed a mean percentage improvement of 37% in the second efficacy trial based on the scoring system of SKATBT-A3. - The first efficacy trial using personalized TCM formulae have shown a mean percentage improvement of 30% in ADHD symptoms and a mean percentage improvement of 37% in ASD symptoms, based on the scoring systems under the Vanderbilt ADHD Diagnostic Parent Rating Scale (“VADRS”) and the Autism Treatment Evaluation Checklist (“ATEC”), respectively, after 3 months of treatment. - The ongoing second efficacy trial using standardized TCM formulae have shown a mean percentage improvement of 21% in ADHD symptoms and a mean percentage improvement of 22% in ASD symptoms, based on the scoring systems under VADRS and ATEC respectively, after 3 months of treatment. HONG KONG--(BUSINESS WIRE)-- Regencell Bioscience Holdings Limited (Nasdaq: RGC) (“Regencell”) today announced its interim results from its second efficacy trial. Regencell conducted its second efficacy trial using standardized Traditional Chinese Medicine (“TCM”) formulae. “Our aim is to save and improve lives by making our standardized TCM formulae widely available to ADHD and ASD patients around the world. It is known that there is a significant economic impact and increased parental burden to families that care for children with ADHD and ASD. These positive data from the second efficacy trial bring us one step closer to improving the conditions and quality of life of patients and reducing the negative impact that ADHD and ASD have on patients and their families,” said Yat-Gai Au, founder and CEO of Regencell. Second Efficacy Trial The primary objective of the second efficacy trial is to evaluate and assess the effectiveness of Regencell’s standardized TCM formulae in reducing ADHD and ASD symptoms through a holistic approach during the course of a 3-month treatment. The second efficacy trial is a non-blinded efficacy trial. Regencell started its recruitment program in August 2021 through direct invitations to members of a non-governmental organization that serves the ADHD and ASD community. Parents and guardians of children with ADHD and ASD were invited to apply for the program. Patients between the ages of 6 and 12 at the time of the treatment and who were clinically diagnosed with ADHD and/or ASD were eligible to participate in the program. The program required all recruited patients to stop all their existing medications, attend weekly treatment sessions with their parents, and follow the TCM Practitioner’s dietary guidelines, during the 3-month treatment. After a rigorous screening process, Regencell selected 7 children (6 males and 1 female) to participate in the trial. 3 of the patients were diagnosed with ADHD and 4 of them with ASD. All participants resided in Hong Kong. To measure the improvement of the children’s symptoms after taking the TCM Formulae in the trial, Regencell used SKATBT-A3, an assessment developed by Regencell based on patients’ overall body and neurodevelopmental conditions; VADRS, an ADHD assessment; and ATEC, an ASD assessment. SKATBT-A3 is a 48-item questionnaire designed and developed by Regencell to evaluate the effectiveness of a treatment in improving ADHD and ASD patients’ symptoms. SKATBT-A3 assesses a patient’s overall physical and neurodevelopmental conditions. SKATBT-A3 includes elements that are conditions of patients usually observed during TCM treatments such as: (i) speech/language/communication; (ii) patients’ sociability; (iii) sensory/cognitive awareness; and (iv) physical health and behavior. For example, SKATBT-A3 examines: the flexibility of the child’s tongue (e.g., prior to treatment, the child may be unable to extend his tongue and had to use his own fingers to pull and stretch his tongue); the child’s willingness and proactiveness to participate in social gatherings and to learn (e.g., the child’s ability to focus and engage in school work); and involuntary twitching. The effectiveness of a treatment is demonstrated through the child’s post-treatment tongue control and flexibility, the ability to focus for a longer period of time and less frequent involuntary twitching. Regencell’s formulae aim to improve blood flow to the brain and remove blood clot over time, thereby alleviating symptoms such as inflexibility and twitching. The TCM Practitioner also believes that as the child's heart is strengthened, more blood is delivered to the brain, resulting in an improved ability to focus. All patients orally consumed the standardized TCM formulae twice daily for 3 months. Improvements in patients’ symptoms were assessed weekly during treatment review sessions with the TCM Practitioner and the children’s parents. Second Efficacy Trial Results Change in SKATBT-A3 scores After 3 months of treatment, SKATBT-A3 scores of all patients were lower, indicating fewer problems and improvements in symptoms. Percentage improvement of patients ranged between 14% and 56%, with a mean of 37%. There were noticeable improvements in the patients’ overall health, ADHD symptoms and ASD symptoms. Common improvements include better sleep quality, reduced temper, better bowel movement and healthier complexion. The most notable improvement were demonstrated by two patients who gained the ability to control their tongues naturally without the aid of their own hands after the 3-month treatment. This is noteworthy because limited tongue function affects verbal communications and language abilities. Change in VADRS scores After 3 months of treatment, the VADRS scores of 5 patients were lower, indicating fewer problems and improvements in symptoms, while 1 patient’s score remained the same and 1 patient’s score was higher. Percentage improvements of patients ranged between -21% and 62%, with a mean of 21%. Change in ATEC scores After 3 months of treatment, the ATEC scores of all patients were lower, indicating fewer problems and improvements in symptoms. Percentage improvement of all patients ranged between 4% and 52%, with a mean of 22%. Among the 4 subscales of ATEC, we saw the most significant drop in scores in the health/physical/behavior subscale. Constipation, sleeping problems, poor appetite, anxiety/fearfulness, and irritability are common issues among ADHD and ASD patients. Most of the patients suffered from these symptoms before the treatment but these symptoms improved after the treatment. No adverse side effects None of the patients experienced any adverse side effects after the 3-month treatment. An Unmet Need Millions of children around the world are diagnosed with ADHD and/or ASD and most of the children diagnosed with ADHD had at least one other mental, emotional or behavioral disorder. In addition to going for behavior therapy, medications are also recommended for children who have ADHD and/or ASD. The two main types of medication for ADHD approved by the US Food and Drug Administration (“FDA”) are stimulants and non-stimulants, while the medication for ASD are usually ‘off-labels’ and are not used in a manner specified in the FDA’s approved packaging label or insert. Such medications for ADHD and ASD usually come with side effects such as difficulty sleeping, loss of appetite, headaches, upset stomach and mood swings, amongst others. To address the need for a natural and holistic treatment for such neurocognitive disorders, Regencell is in the midst of conducting further efficacy trials on its standardized TCM formulae to corroborate the effectiveness of the TCM formulae before it is made available to people around the world. Regencell Standardized TCM Formulae Regencell standardized TCM formulae are natural, orally administered liquid TCM formulae for the treatment of ADHD and ASD. In conducting its second efficacy trial, the standardized TCM formulae were administered to children twice daily for a period of 3 months. Regencell standardized TCM formulae were developed by our strategic partner TCM Practitioner based on his Sik-Kee Au TCM Brain Theory® and consists solely of natural ingredients without any synthetic components. The TCM formulae have been used for over 30 years to treat ADHD, ASD and many other neurological illnesses, disorders and diseases and have achieved positive clinical treatment results. The TCM brain theory explains why a healthy brain is essential in restoring the body’s systems to normal. According to the TCM brain theory, the blockage of or reduced blood flow, and damage of the interconnecting central nervous system, endocrine system and blood circulatory system disrupt the production of hormones and transmission of neurotransmitters, such as melatonin, dopamine, and norepinephrine, leading to a defective encoding and decoding of functions, and resulting in deficient or abnormal social behaviors that are the hallmarks of ADHD and ASD. Regencell Bioscience Holdings Limited Regencell Bioscience Holdings Limited is an early-stage bioscience company that focuses on the research, development and commercialization of TCM for the treatment of neurocognitive disorders and degenerations, specifically ADHD and ASD, and infectious diseases affecting people’s immune system such as COVID-19. Regencell has completed its first research study using personalized TCM formulae for the treatment of ADHD and ASD in Hong Kong and aims to launch three liquid-based standardized TCM formulae candidates for mild, moderate and severe ADHD and ASD patients initially in Hong Kong and subsequently in other markets as it deems appropriate. The Company has formed a joint venture to offer COVID-19 related treatments to patients in ASEAN countries, India, Japan, Australia and New Zealand. For more information, please visit and . Forward-looking Statements This press release contains “forward‐looking statements” within the meaning of applicable laws, including U.S. federal securities laws. These forward‐looking statements may include, but are not limited to, statements relating to our objectives, plans, and strategies; statements that contain projections of results of operations or of financial condition; statements relating to the research, development, and use of our platform technologies, technologies, products and product candidates; and all statements that address activities, events, or developments that we intend, expect, project, believe, or anticipate will or may occur in the future. The risks and uncertainties of our company include: our ability to obtain regulatory approval and ultimately commercialize our TCM formulae and/or products based on our TCM formulae; the outcome of our research study free from biases of parents or caregivers of patients because we relied on the data provided by them; difficulties enrolling patients in our research studies; any undesirable side effects caused by the TCM formulae candidates which could delay or prevent their regulatory approval or hinder commercialization; whether results of our earlier studies on personalized TCM formulae can be predictive of future research study results; failure of the research and development process; whether any TCM formulae candidates can be developed, manufactured, sold, marketed and distributed; the ability to successfully commercialize any future therapeutics; our ability to enhance our brand recognition; our ability to obtain and protect our intellectual property; and any adverse publicity associated with our TCM formulae candidates, ingredients or network marketing programs. We have based these forward‐looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. We have also relied upon and assumed, without independent verification, the accuracy and completeness of all information available from public sources and makes no express or implied warranty as to the accuracy or completeness of any such information. Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this presentation, they may not be indicative of results or developments in future periods. For a discussion of these and other risks and uncertainties, see our Annual Report on Form 20-F for the year ended June 30, 2021, which is available on the SEC’s website at . All information in this press release is as of the date of the release, and we undertake no duty to update this information unless required by law. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Glen Rock, N.J., Aug. 08, 2022 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (OTCQ:RSPI) (“RespireRx” or the “Company”), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that Sleep Review Magazine has published, in its June 13, 2022 edition, a free e-book entitled “How Close Are We to Drug Therapy for Obstructive Sleep Apnea?”, in which it discusses the RespireRx dronabinol OSA program as one of four emerging drug treatments for the treatment of OSA. (https://sleepreviewmag.com/sleep-disorders/breathing-disorders/obstructive-sleep-apnea/how-close-drug-therapy-obstructive-sleep-apnea/). Editor Sree Roy stated, “For decades, scientists have been searching for a drug therapy for obstructive sleep apnea (OSA)… An oral pharmacologic treatment that keeps airways open during sleep would be a game-changer… An oral pharmacologic treatment would represent a shift in the perception of sleep apnea therapy, likely resolving adherence obstacles associated with medical device-based treatments for many patients. It could also lead to increased willingness among people with OSA symptoms to undergo sleep testing. I wonder how many people who experience excessive daytime sleepiness refuse diagnosis because they are intimidated by currently available sleep apnea treatment options (or at least by their limited knowledge of available treatments)? Sleep specialists too would also welcome another treatment option—more therapies mean more opportunities to find a therapy most compatible to every patient.” Two Phase 2 clinical trials have been completed demonstrating the ability of dronabinol to significantly reduce the symptoms of OSA and, subject to raising sufficient financing (of which no assurance can be provided) and pending the outcome of an intended meeting with the FDA, RespireRx believes that it will be able to commence a pharmacokinetic study for a recently discovered and to-be-developed formulation followed by a Phase 3 clinical study for the treatment of OSA with the new formulation. “Dronabinol is being developed by ResolutionRx, a business unit of the RespireRx. It will be my pleasure to discuss with colleagues the latest developments in pharmaceutical cannabinoids and meet with potential business partners,” said Dr. Lippa About RespireRx Pharmaceuticals Inc. RespireRx Pharmaceuticals Inc. is a leader in the discovery and development of medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including obstructive sleep apnea (“OSA”), attention deficit hyperactivity disorder (“ADHD”), epilepsy, pain, recovery from spinal cord injury (“SCI”) and certain neurological orphan diseases. RespireRx is developing a pipeline of new and re-purposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ∆9-tetrahydrocannabinol (“Δ9-THC”) that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which include AMPAkines and GABAkines, proprietary chemical entities that positively modulate (positive allosteric modulators or “PAMs”) AMPA-type glutamate receptors and GABAA receptors, respectively. The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs. ResolutionRx: Pharmaceutical Cannabinoids. Dronabinol. RespireRx’s ResolutionRx business unit is developing dronabinol, ∆-9-THC, a synthetic version of the naturally occurring substance in the cannabis plant, for the treatment of OSA, a serious respiratory disorder that impacts an estimated 29.4 million people in the United States according to the American Academy of Sleep Medicine (“AASM”), published in August 2016. OSA has been linked to increased risk for hypertension, heart failure, depression, and diabetes, and has an annual economic cost in the United States of $162 billion according to the AASM. There are no approved drug treatments for OSA. Two Phase 2 clinical trials have been completed demonstrating the ability of dronabinol to significantly reduce the symptoms of OSA and, subject to raising sufficient financing (of which no assurance can be provided) and pending the outcome of an intended meeting with the FDA, RespireRx believes that it will be able to commence a pharmacokinetic study for a recently discovered and to-be-developed formulation followed by a Phase 3 clinical study for the treatment of OSA with the new formulation. Because dronabinol is already FDA approved for the treatment of AIDS related anorexia and chemotherapy induced nausea and vomiting, the Company further believes that its re-purposing strategy would only require approval by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway that allows the use of publicly available data. EndeavourRx: Neuromodulators GABAkines. Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. (“UWMRF”) and on behalf of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. The Company currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain. KRM-II-81 has displayed a high degree of anti-convulsant activity in a broad range of preclinical studies, including in treatment resistant and pharmaco-resistant models. Not only was KRM-II-81 highly effective in these models, but pharmaco-resistance or tolerance did not develop to its anti-convulsant properties. These latter results are particularly important because pharmaco-resistance occurs when medications that once controlled seizures lose efficacy as a result of chronic use and it is a principal reason some epileptic patients require brain surgery to control their seizures. In support of its potential clinical efficacy, translational studies have demonstrated the ability of KRM-II-81 to dramatically reduce epileptiform electrical activity when administered in situ to brain slices excised from treatment resistant epileptic patients undergoing surgery. In addition, KRM-II-81 has displayed a high degree of analgesic activity in a broad range of preclinical studies. In intact animal models of pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic. AMPAkines. Through an extensive translational research effort from the cellular level through Phase 2 clinical trials, the Company has developed a family of novel, low impact AMPAkines, including CX717, CX1739 and CX1942 that may have clinical application in the treatment of CNS-driven neurobehavioral and cognitive disorders, spinal cord injury, neurological diseases, and certain orphan indications. Our lead clinical compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials. Both compounds have also completed Phase 2 proof of concept trials demonstrating target engagement, by antagonizing the ability of opioids to induce respiratory depression. AMPAkines have demonstrated positive activity in animal models of ADHD, results that have been extended translationally into statistically significant improvement of symptoms observed in a Phase 2 human clinical trial of CX717 in adult patients with ADHD. Statistically significant therapeutic effects were observed within one week. We believe AMPAkines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative non stimulants, such as Straterra® (atomoxetine), and without the drawbacks of amphetamine-type stimulants. In a series of important studies funded by grants from the National Institutes of Health and published in a number of peer reviewed articles, Dr. David Fuller (University of Florida), a long-time RespireRx collaborator, has demonstrated the ability of CX1739 and CX717, the Company’s lead AMPAkines, to improve motor nerve activity and muscle function in animal models of spinal cord injury (SCI). Additional information about RespireRx and the matters discussed herein can be obtained on the Company’s web-site at www.RespireRx.com or in the Company’s filings with the Securities and Exchange Commission at www.sec.gov. Not a Securities Offering or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sales of securities in any jurisdiction in which such offer, solicitation or sale of securities would be unlawful before registration or qualification under the laws of such jurisdiction. Cautionary Note Regarding Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Company intends that such forward-looking statements be subject to the safe harbor created thereby. These might include statements regarding the Company’s future plans, targets, estimates, assumptions, financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing factors. In some cases, forward-looking statements may be identified by words including “assumes,” “could,” “ongoing,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” “anticipates,” “believes,” “intends,” “estimates,” “expects,” “plans,” “contemplates,” “targets,” “continues,” “budgets,” “may,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words, and such statements may include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii) potential collaborative arrangements, (iii) the potential utility of the Company’s product candidates, (iv) reorganization plans, and (v) the need for, and availability of, additional financing. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. These factors include but are not limited to, regulatory policies or changes thereto, available cash, research and development results, issuance of patents, competition from other similar businesses, interest of third parties in collaborations with us, and market and general economic factors, and other risk factors disclosed in “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC on April 15, 2022 (the “2021 Form 10-K”). You should read these risk factors and the other cautionary statements made in the Company’s filings as being applicable to all related forward-looking statements wherever they appear in this press release. We cannot assure you that the forward-looking statements in this press release will prove to be accurate and therefore prospective investors, as well as potential collaborators and other potential stakeholders, are encouraged not to place undue reliance on forward-looking statements. You should read this press release completely. Other than as required by law, we undertake no obligation to update or revise these forward-looking statements, even though our situation may change in the future. We caution investors, as well as potential collaborators and other potential stakeholders, not to place undue reliance on any forward-looking statement that speaks only as of the date made and to recognize that forward-looking statements are predictions of future results, which may not occur as anticipated. Actual results could differ materially from those anticipated in the forward-looking statements and from historical results, due to the risks and uncertainties described in the 2021 Form 10-K and in this press release, as well as others that we may consider immaterial or do not anticipate at this time. These forward-looking statements are based on assumptions regarding the Company’s business and technology, which involve judgments with respect to, among other things, future scientific, economic, regulatory and competitive conditions, collaborations with third parties, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. Our expectations reflected in our forward-looking statements can be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties, including those described in the 2021 Form 10-K and in this press release. These risks and uncertainties are not exclusive and further information concerning us and our business, including factors that potentially could materially affect our financial results or condition, may emerge from time to time. For more information about the risks and uncertainties the Company faces, see “Item 1A. Risk Factors” in our 2021 Form 10-K. Forward-looking statements speak only as of the date they are made. The Company does not undertake and specifically declines any obligation to update any forward-looking statements or to publicly announce the results of any revisions to any statements to reflect new information or future events or developments. We advise investors, as well as potential collaborators and other potential stakeholders, to consult any further disclosures we may make on related subjects in our annual reports on Form 10-K and other reports that we file with or furnish to the SEC. Company Contact: Jeff MargolisSenior Vice President, Chief Financial Officer, Treasurer and SecretaryTelephone: (917) 834-7206E-mail: jmargolis@respirerx.comRespireRx Pharmaceuticals Inc.126 Valley Road,Suite C,Glen Rock, NJ 07452www.respirerx.com