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Osteopore "chasing the holy grail of tissue regeneration”

Osteopore Ltd

Osteopore Ltd (ASX:OSX) Chairman Mark Leong speaks to Thomas Warner from Proactive London about the Australian-Singaporean medical technology company's pursuit of what he calls the "holy grail of tissue regeneration." Leong explains that aiming to commercialise products designed to enable natural bone healing across multiple therapeutic areas, including both hard and soft tissue. Initially focused on bone regeneration, Osteopore has received major regulatory approvals for their implants. However, their technology also holds promise for soft tissue regeneration, including shoulder rotator cuff tendon repair and cartilage regeneration. Looking ahead, the company aims to enter the "huge" Chinese market and is actively researching ways to accelerate tissue regeneration, potentially reducing healing time significantly. He says "In the next half a year or so you'll see us breaking some new ground into entering the Chinese market... and on the technology front we will be putting more effort into developing the soft tissue part because that's a whole new area of therapeutic treatment... we are chasing the holy grail of tissue regeneration which is to speed up tissue regeneration." Contact Details Proactive Australia Pty Ltd Proactive Australia Pty Ltd +61 431 597 771 action.australia@proactiveinvestors.com

July 27, 2023 06:00 PM Eastern Daylight Time

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Oxford Cannabinoid Technologies "officially on the way" after first dosing

Oxford Cannabinoid Technologies Holdings PLC

Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTCQB:OCTHF) Clarissa Sowemimo-Coker speaks to Thomas Warner from Proactive London after announcing that the company has commenced its phase I clinical trial for the lead drug candidate, OCT461201, marking the administration of the first human dose. Researchers will assess the pain relief treatment's safety, tolerability, and pharmacokinetic profile (how it interacts with the body). Sowemimo-Coker says its "so important to have that significant milestone of finally getting that first dose into a healthy volunteer, so we can officially say we're on the way and looking forward to getting those results over time." The trial holds promise for patients suffering from chemotherapy-induced peripheral neuropathy (CIPN), a condition affecting 60% of chemotherapy recipients, causing severe pain and sensitivity in extremities. Sowemimo-Coker also highlights the recent addition to the team of Dr. Farquhar Smith, who runs the only CIPN clinic in the UK at the Royal Marsden. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 27, 2023 10:39 AM Eastern Daylight Time

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Oxford Cannabinoid Technologies first dosing a "major achievement" - Proactive Research Analyst

Oxford Cannabinoid Technologies Holdings PLC

Proactive Research Analyst Daniel Appiah speaks to Thomas Warner at the London Studio after publishing a new research note on Oxford Cannabinoid Technology Holdings PLC. The pharmaceutical group announced on 27 July that it has commenced its phase I clinical trial for lead drug candidate, OCT461201, marking the administration of the first human dose. Appiah describes the news as a "major achievement" for Oxford Cannabinoid Technologies, highlighting its transformation from a development company into being a clinical company He also gives an overview of other recent news from the business. For more details, read Daniel's full report by clicking the link provided. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 27, 2023 10:38 AM Eastern Daylight Time

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PathAI Launches its AI-Powered PathExplore Data Access Program for Academic Researchers

PathAI

PathAI, a global leader in AI-powered pathology, today announced it has applied its PathExplore panel of human interpretable features (HIFs) on publicly available samples from The Cancer Genome Atlas (TCGA), a comprehensive resource of oncology data containing genomic and outcomes data, along with associated H&E whole-slide images (WSIs). PathAI will make the HIFs from eight TCGA cancer types available for free as a data access program for academic researchers to perform independent research to support their own investigations. Earlier this year, PathAI launched PathExplore, an AI-powered panel of HIFs offering unprecedented resolution of the tumor microenvironment (TME) from digitized H&E slides. Powered by artificial intelligence, PathExplore spatially characterizes the TME with single-cell resolution, giving researchers the ability to unlock insights on patient response, drug pathways, and potential novel biomarkers. The ability to characterize and quantify histopathological features of the TME will enable new avenues of disease research, and may lead to promising new therapies. With this PathExplore HIF research data set, oncology researchers can analyze tissue compositions, cell populations, and how their quantities and spatial relationships correlate with molecular signatures, treatment response or prognostic outcomes. This data set is the first of its kind: no other widely available quantitative, structured data set based on histopathology exists. The features are standardized across indications, so researchers can glean new insights into the common or distinct TME characteristics of each tumor type or patient subset. Adding structured and standardized pathology data to TCGA enables a new set of multi-model investigations for researchers to pursue, all while lowering the barrier to integrating pathology image data into biomedical research that previously had been restricted to labs that had access to manual pathology analysis. “The TME has been a challenge to fully investigate due to the sheer amount of spatially distributed information contained within it,” said Mike Montalto, PathAI’s chief scientific officer. “Pathologists can assess the specimens and try to estimate how certain cell or tissue growth patterns are present in each patient, but they cannot exhaustively enumerate each and every relevant cell type under the microscope. That is what our PathExplore products provide - they not only accurately identify where each cell is located, but they provide structured and standardized feature tables that can enable next generation pathology research to be performed.” To learn more about PathAI’s PathExplore HIF research data set and apply for access, please reach out to pathexplore.hifs@pathai.com. If approved, there is no cost to academic researchers to access and use these data sets. PathExplore HIFs are for research use only and not for use in diagnostic procedures. Biopharma industry partners interested in purchasing a license to access PathExplore TCGA HIFs may reach out to bd@pathai.com for more information. PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

July 27, 2023 10:00 AM Eastern Daylight Time

DSS, Inc.’s (NYSE American: DSS) Subsidiary Appoints New Chief Investment Officer to Aggressively Develop Mutual Fund Business for Eventual Spinoff

DSS, Inc.

By David Willey, Benzinga DSS Wealth, Inc. has appointed Daniel Lew as its new Chief Investment Officer (CIO) and Portfolio Manager. DSS Wealth is a mutual fund and a wholly-owned subsidiary of DSS, Inc. (NYSE American: DSS), a multinational that looks to increase shareholder value through incubating and spinning off potentially lucrative companies. DSS, Inc. operates around 40 companies through 9 divisions targeted for high-growth potential, including healthcare, real estate and renewable energy. As its new CIO, Lew will manage DSS Wealth's investment strategies, resource allocation, and risk management to achieve clients' financial goals. He has several decades of experience managing investments, as well as in security analysis and institutional client advisory. Senior investment management positions he has held include those at companies like AIG SunAmerica, Strong Capital, John Hsu Capital, Citizens Advisers and Equitable Capital. Along with his management positions, Lew has also consulted for institutional funds at both William M. Mercer and RogersCasey. Lew’s appointment reflects DSS Wealth's commitments both to attracting top talent and to providing their clients with outstanding investment solutions and personalized service. Daniel Lew, said, "I joined DSS Wealth, Inc. with the mission to build a strong, seasoned team that will deliver better fund performance for DSS AmericaFirst Fund shareholders and to grow assets under management. I am excited that the stock market has been strong, largely driven by a select group of the largest stocks (The Magnificent Seven) in the first half, and now we are seeing signs of breadth expanding to undervalued stocks, especially high dividend and smaller caps. Expanding breadth is usually a strong bullish sign that stocks have much further to run. There is currently over $5 trillion in assets sitting in money market funds to add fuel to the fire." Promoting DSS’ Mission As its new Portfolio Manager, Daniel Lew will leverage his wide-ranging industry experience to drive investment decisions and generate superior returns for clients of DSS Wealth. The company also advises DSS AmericaFirst Quantitative Funds, which approaches investing by using a unique quantitative approach that helps the fund achieve its investment goals. Bringing on Lew is a key strategic move to help grow DSS Wealth, even as the confidence of some hedge fund managers has faltered during 2023. The move comes with the objective of positioning Lew and DSS Wealth to aggressively develop in the sector and advance DSS, Inc.’s overall strategy of incubating and spinning off companies. Lew added, "I was attracted to DSS because of the fact that there are many good underlying businesses here with experienced management teams that are in various stages of turnaround and growth. At the right point, executive management is committed to unlocking those values via spinouts, sales, or mergers. The appreciation potential for patient investors is considerable and I'm very excited to be able to play a role in building shareholder value.” Jason Grady, Chief Operating Officer at DSS, Inc., commented on Lew’s appointment, “His extensive experience, track record, impressive credentials, and demonstrated expertise make him an invaluable addition to our firm. We are confident that under his leadership, our investment strategies will deliver exceptional results for our clients.” DSS, Inc. recently confirmed the highly-anticipated spinoff in its biotech subsidiary, Impact Biomedical. Investors will be awarded four shares of Impact for every share they own in DSS once the company is spun off. The decision to spin off Impact is following the major announcement that its subsidiary Global BioLife, Inc. has signed a licensing partnership with ProPhase BioPharma Inc. (NASDAQ: PRPH) to develop two promising therapeutics, Equivir and Linebacker, from Global BioLife. Within the next few fiscal quarters, DSS plans to spin off two other successful subsidiaries, the medical real estate investment trust, AAMI/AMRE, and the financial services company, American Pacific Bancorp. DSS, Inc. may offer risk-tolerant investors an attractive approach to building a diversified portfolio of future stock dividends as the company executes its business plan of periodic subsidiary spinoffs to its shareholders. Learn more about DSS, Inc. by visiting its website. DSS is a multinational company operating businesses within nine divisions: Product Packaging, Biotechnology, Direct Marketing, Commercial Lending, Securities and Investment Management, Alternative Trading, Digital Transformation, Secure Living, and Alternative Energy. DSS strategically acquires and develops assets to enrich the value of its shareholders through calculated IPO spinoffs and a parametric share distribution strategy. Since 2019, under the guidance of new leadership, DSS has built the necessary foundation for achievable growth through the formation of a diversified portfolio of companies positioned to drive profitability in multiple high growth sectors. These companies offer innovative, flexible, and real-world solutions that not only provide mutual benefits for businesses and their customers, but also create sustainable value and opportunity for transformation. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice Contact Details Rick Lutz- TraDigital IR rick@tradigitalir.com Company Website https://www.dssworld.com/

July 27, 2023 09:00 AM Eastern Daylight Time

hVIVO CEO reports on "very strong" H1 2023

hVIVO PLC

hVIVO PLC (AIM:HVO) chief executive Mo Khan speaks to Thomas Warner from Proactive after the specialist contract research organisation released a trading update for first half of 2023 - a period he describes as a "very strong six months." Khan gives his highlights from the update, highlighting a 52% year-on-year increase in revenues to £27.3mln. He attributes the growth to improved operational efficiencies and the increasing frequency of large concurrent trials. The company reports cash reserves of £31.3 million, even after paying out a special dividend of £3 million, with an order book of £78 million. Addressing a technical detail, Khan mentioned that the company would now report revenue exclusive of other income to align with industry practice. Despite delays at the Medicines and Healthcare Products Regulatory Agency impacting some UK clinical trials, Khan says that hVIVO has successfully managed the situation through its risk mitigation strategy. For the next six months, hVIVO plans to maintain its growth momentum, with full-year guidance of £53 million in revenue and an ever-expanding order book. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

July 27, 2023 08:36 AM Eastern Daylight Time

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Powering Multiple CPG Industries With A 'Secret Sauce': Bioscience Company Reports Its Proprietary Nanotech Improves Taste And Absorption Of Functional Foods & Beverages

Rexis Biotech

By Rachael Green, Benzinga This month, Rexis Biotech, the company behind an innovative new nano fiber technology for creating highly water-soluble infusions from hydrophobic molecules, announced a new partnership with 3Chi, Inc. The partnership makes Rexis the world’s largest hemp-derived cannabis manufacturer and will see 3Chi’s initial order of 1M cans distributed via Rexis’ massive national distribution network. The agreement is the latest in a string of major contracts Rexis has landed this year, and the news comes in the midst of the biotech’s ongoing crowdfunding campaign through WeFunder, where Rexis is seeking to raise equity and awareness of its new technology. Rexis Is Leveraging Its Proprietary Fused Polymorph Nano Fiber Technology To Improve The Quality And Potency Of Consumer Goods Rexis uses a proprietary co-crystal in a patented procedure that creates a completely tasteless and odorless powder for infusing into foods and beverages. Co-crystallization combines two or more molecules into a single stable crystal structure. It’s already being used in the pharmaceutical industry to improve the bioavailability of drugs. But it’s typically been limited to small-scale or specialized production because it’s a complex and expensive process. Trademarked under the name Fused Polymorph Nano Fiber Technology, this advanced co-crystallization platform turns hydrophobic molecules like CBD, THC and many essential vitamins into nanoparticles ranging from 35 to 50 nanometers. For scale, a single viral cell is about 50 to 100 nanometers. This tiny size makes the ingredients easier for the human body to absorb because it is mostly absorbed within the mouth, well before first past digestion. Clinical research has found that CBD processed using Fused Polymorph Nano Fiber Technology TM is more than 48% bioavailable, for example. That’s a substantial improvement over the 6% bioavailability of standard CBD oil. Better bioavailability means more of the active ingredient is actually getting absorbed into the bloodstream. For ingredients like CBD or THC, that can mean a faster onset of effects and the ability to get the effects you need with a lower dose. Rexis says its proprietary nano fibers can be absorbed into the bloodstream more quickly and completely than standard emulsions. They can even adjust the length of the fibers to speed up or slow down the onset/offset timing. CBD oil isn’t the only poorly-absorbed ingredient on the market. Many of the most popular supplements contain hydrophobic vitamins like Vitamin A, C, D, E, and K. Other functional ingredients like caffeine and many of the essential amino acids the body needs to make protein are also hydrophobic. In addition to being poorly absorbed, the amount that actually makes it into the bloodstream can vary depending on a range of factors. That means you can take the exact same dose and get different results. The technology Rexis uses is meant to not only improve those absorption rates but also make them more consistent so that consumers can more reliably predict what dose to take to meet their needs while ensuring taste is retained or improved – this gives the company a potentially large total addressable market spread across multiple industries. Rexis Is Gaining The Attention Of Industry Leaders Across Key Markets Manufacturers are already hopping on board to use this Fused Polymorph Nano Fiber Technology TM in their supplements, beverages, and other consumer products. Rexis says it’s already signed more than $8.35 million worth of contracts in the first half of this year with a range of clients in rapidly growing industries like cannabis, wellness and functional beverages – the company boasts of powering brands like 3Chi and First Person Group thanks to its focus on retaining or improving taste. In addition to the million dollar agreement with 3Chi this month, the company has signed contracts with other cannabis leaders like Happy Valley, Redbud Roots and Nectr. But it’s not just licensing its tech to customers. Rexis is also developing its own line of retail brands and pharmaceuticals to add additional revenue streams and showcase the wide-ranging potential of this technology. Meanwhile, investors have already helped the biotech raise over $260K through its crowdfunding campaign. For investors interested in learning more, check out their WeFunder page. Rexis is the industry leader and pioneer in developing Hydrophobic Molecule Delivery systems. Leading in the innovation, production and formulation of water based ingredients for use in the Pharmaceutical and Consumer Packaged goods industry. Established in 2022, Rexis is building a core mix of proprietary IP used to sustain strong sales models with pharmaceutical licensees, consumer packaged goods manufacturers and clinical research teams. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Ryan Erving ryan@rexissystems.com Company Website https://www.rexissystems.com

July 26, 2023 09:25 AM Eastern Daylight Time

AMA Issues Details On First Psychedelics Therapy CPT Code – Thanks To These Psychedelic-Focused Mental Healthcare Companies

COMPASS Pathways

By Rachael Green, Benzinga The American Medical Association’s (AMA) Panel recently released the full details of a new code for psychological support during the administration of psychedelic treatments. Slated to take effect starting in 2024, the new temporary CPT III code marks an important step toward broader access to the novel treatments as it gives healthcare providers a way to code and seek reimbursement for psychological support during the administration of any FDA-approved psychedelic therapies given to patients. The addition of the psychedelics code was made possible by Compass Pathways Plc. (NASDAQ: CMPS), a company conducting clinical trials of psilocybin treatment using COMP360, COMPASS’s proprietary formulation of synthetic psilocybin, and MAPS Public Benefit Corporation (PBC), two companies developing psychedelics-based treatments for mental health conditions. The two companies submitted a joint application to the AMA to add a new CPT III code for psychedelic therapies. CPT Codes Lend Legitimacy To Emerging Psychedelics Market While no psychedelic has yet been approved by the Food and Drug Administration (FDA) for the market, a growing body of research from the last decade or so has yielded positive data on the therapeutic potential of substances like psilocybin, MDMA or LSD for a range of some of the most common and most difficult to treat mental health conditions. “Psychedelic-assisted therapies represent a potential new frontier in the treatment of mental health conditions and our top priority is ensuring there is a path forward to integrate them into the healthcare system, if FDA approved,” said MAPS CEO Amy Emerson. The new CPT code paves the way for psychedelics – subject to FDA approval – to become a widely adopted set of new therapeutics. “This is a major step forward to enabling broad and equitable access to psychedelic therapies,” said Compass CEO Kabir Nath. CPT coding is a standardized set of codes used nationwide for reporting of medical services and procedures, claims processing and developing guidelines for medical care review. Essentially, if psychedelic therapies are approved, this new code is the basis for what will be used to document treatment in patient medical records and submit claims to payers for reimbursement. COMPASS And MAPS Are Also Edging Closer To FDA Approval With Late Stage Clinical Trials The AMA’s acceptance of COMPASS and MAPS PBC’s new code application puts the mechanisms for adoption in place if either company is granted FDA approval for their psychedelic therapies. With that code in place, both companies are working to move their current late-stage clinical trials through the approval process. A phase 3 trial is already underway for COMP360, the synthetic psilocybin treatment developed for treatment-resistant depression (TRD). The trial is building on the company’s phase 2b trial, in which 30% of TRD patients achieved remission by the third week after taking just one 25-milligram dose at the start of the trial. At the 12-week follow-up, over 20% of patients were still in remission. These results are promising given the challenging TRD patient population. Less than a third of people diagnosed with depression achieve full remission with the first antidepressant they try – and even when they do, it takes an average of about seven weeks of daily medication for remission to happen. For treatment-resistant depression – where a patient has been failed by at least two different antidepressants – the numbers are even worse. Remission rates for patients trying a third antidepressant range from just 8% to 12%, depending on the specific antidepressant tried. From the fourth treatment attempt onward, remission rates remain low. The COMP360 trial outcomes suggest it could be a meaningful alternative for these patients who struggle to find any relief with the current standards of care. The phase 3 program currently underway will be conducted across approximately 150 sites worldwide. Two other phase 2 trials are also being conducted, one for post-traumatic stress disorder (PTSD) and another for anorexia nervosa. Meanwhile, MAPS already has two phase 3 trials under its belt, both for an MDMA-assisted therapy it developed for PTSD. In the first of those trials, 88% of participants saw meaningful improvement in their symptoms with the treatment while 67% responded so well that they no longer met the diagnostic criteria for PTSD after 18 weeks. Based on that data and its previous trials, the company is preparing to submit a new drug application to the FDA in the third quarter of this year. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz stephen.schultz@compasspathways.com

July 25, 2023 09:25 AM Eastern Daylight Time

Novel Chinese medicine for constipation developed by HKBU authorised by U.S. FDA for clinical trial

Hong Kong Baptist University

HONG KONG SAR - Media OutReach - 25 July 2023 - The Centre for Chinese Herbal Medicine Drug Development (CDD) of Hong Kong Baptist University (HKBU) has made significant progress in developing novel Chinese medicine for treating chronic constipation. With its success in the Investigational New Drug Application to the U.S. Food and Drug Administration (FDA), CDD has been authorised to conduct a phase I clinical trial of the new drug. This is the first time that a new botanical drug developed in Hong Kong was authorised to conduct a clinical trial in the US. The clinical trial will be launched later this year to evaluate the safety, tolerability, and pharmacokinetics profile of the new drug on healthy individuals. Research based on traditional Chinese herbal formulation Chronic constipation is a common gastrointestinal disorder affecting approximately 14% of the global population. Currently, many patients with chronic constipation are not completely satisfied with their current treatments due to side effects and/or limited efficacy. In response to the patients' needs for better therapeutics, CDD has been eyeing the international market and has developed a new drug called CDD-2101, which is based on previous pilot clinical studies and basic research on the traditional Chinese herbal formulation "MaZiRenWan". The main ingredients of CDD-2101 include hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root. The HKBU research team collaborated with partners including the University of Chicago and the University of Macau to submit an Investigational New Drug Application for CDD-2101 according to the requirements for botanical drug development of the U.S. FDA and was authorised to conduct a phase I clinical trial. Milestone of standardisation and internationalisation of Chinese medicine Professor Alexander Wai, President and Vice-Chancellor of HKBU, said: "HKBU is committed to promoting the development of Chinese medicine, and conducting cutting-edge scientific and translational research in this area. The University received funding from the Innovation and Technology Commission's InnoHK initiative to establish the CDD in 2020, which significantly boosted our comprehensive capabilities in the research and development of Chinese medicine. The clinical trial in the US will provide us with invaluable experience in conducting clinical trials at Hong Kong's first Chinese Medicine Hospital in future." Professor Bian Zhaoxiang, Associate Vice-President (Chinese Medicine Development), Director of the Clinical Division of the School of Chinese Medicine, and Director of the CDD at HKBU, said: "CDD-2101 is a novel drug developed by combining a traditional Chinese herbal formulation and advanced technologies, with research and manufacturing conducted in compliance with international standards. Obtaining U.S. FDA's authorisation to conduct a clinical trial for this new drug is an important milestone in the development of Chinese medicine in Hong Kong, and it reflects HKBU's capabilities in and dedication to promoting the standardisation and internationalisation of Chinese medicine." Authorisation from the U.S. FDA was secured in April this year to conduct a phase I clinical trial of CDD-2101 in the US. The trial will start later this year and will recruit 20 healthy participants in the US. It will be a randomised, double-blinded, and placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics profile of the drug. Participants will take a single dose of CDD-2101 or a placebo and be monitored for 24 hours. The study will be conducted at a phase I clinical research centre in the US. Phase I trial focuses on safety The phase I clinical trial is expected to be completed in 2024, followed by a phase II study to collect the safety and efficacy data from patients with chronic constipation. A large-scale phase III study will then be launched to further evaluate the treatment efficacy of CDD-2101 in patients with chronic constipation, and monitor any unforeseeable side effects. Professor Bian said: "The ultimate goal of the drug development programme is to collect sufficient safety and efficacy data, so that CDD-2101 can be evaluated and approved by the U.S. FDA as a new pharmaceutical for sale and marketing in the US. This is essential in establishing CDD-2101 as an internationally recognised, safe and effective drug for the treatment of chronic constipation. It is anticipated that another three to five years are needed to complete the phase II and III clinical trials, after which the data gathered during the animal studies and human clinical trials, together with details of the manufacturing of the drug, will be included in a New Drug Application to be submitted to the U.S. FDA for review." The CDD, funded by the Innovation and Technology Commission's InnoHK initiative, is the first integrated Chinese medicine research and development centre at a local university. Located in the Hong Kong Science and Technology Parks and equipped with advanced facilities, the CDD aims to gather world-class partners to translate the wisdom of traditional Chinese medicine wisdom into pharmaceutical products that meet international standards. Since its establishment in 2020, the CDD has been focusing on innovative Chinese medicine research for gastrointestinal and immune-related diseases such as chronic constipation and ulcerative colitis. Contact Details Wong Suk-ling +852 3411 2119 hkbunews@hkbu.edu.hk

July 25, 2023 09:00 AM Eastern Daylight Time

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