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1% of oral dose for 30x higher lung exposure and reduced cardiotoxicity A cost-effective, available and easy-to-use prevention option
SOUTH SAN FRANCISCO, California and TAIPEI, Taiwan, August 14, 2020 (GLOBE NEWSWIRE) – TLC (Nasdaq: TLC, TWO: 4152, a clinically specialized pharmaceutical company that presents new nano-taxes to target spaces of unmet medical needs, today announced the submission of a new application for experimental medicine (IND) to the Taiwan Food and Drug Administration (TFDA) for the suspension of inhalation of hydroxychloroquine liposomes TLC19 for the remedy of coronavirus disease 2019 (COVID-19).
Is hydroxychloroquine (HCQ) still a viable drug for the salvation and remedy of COVID-1nine? Studies conducted through X. Yao et al and S. Perinel et al recommend that HCQ would possibly prevent acidification of intramobileular organelles, inhibit lysosomal release of the viral genome and interfere with the glycosylation of the angiotensin-2 conversion enzyme (ACE2) receptor in the mobile host, cutting off the binding power between the receptor and the complex protein on the surface of the receptor , thus, cutting off the threat of infection and replication of COVID-1nine. Therefore, at the molecular and mobile level, HCQ has been shown to have antiviral activity compared to SARS-CoV-2, the strain of coronavirus that causes COVID-1nine. A review through Fan et al, a pharmacokinetic review team from the U.S. Food and Drug Administration (FDA), under pressure on the importance of translating in vitro antiviral activity into appropriate clinical regimens, concluded that “the antiviral effect opposite SARS-Cov-2 [is] unlikely with a safe oral regimen of HCQ due to dose containment through prospective cardiotoxicity. The FDA revoked emergency use authorization for HCQ and recent oral HCQ clinical trials, such as SOLIDARITY and RECOVERY, which proposed the highest 1600 mg regimen on day 1 and 800 mg over the next nine days, were discontinued. Fan et al recommended that “a strategy to increase drug exposure at the site of action (e.g. through targeted administration) minimizing systemic exposure would possibly be desirable.”
TLC19 uses patented lipoosomal generation of TLC to encapsulate 1/100 of the oral dose of HCQ in inhalable formulas for direct deposition in airlines and lungs. A recent manuscript showed that in doses, inhaled liposomic HCQ increased exposure (up to 30 times) and half-life (2.5 times) in the lungs compared to oral HCQ. Therefore, TLC19 can achieve an antiviral effect with a small dose compared to oral HCQ while reducing blood and heart exposure, giving TLC19 the possibility of treating COVID-19.
TLC19 is administered using a vibrating sieve nebulizer. TLC is working with MicroBase Technology Corporation, which specializes in the progression of inhalation devices for the remedy of respiratory diseases with a iso 17025 accredited laboratory capable of analyzing the performance of aerosols, to boost the progression of suspension formulas for inhalation of FTA19.
In May 2020, TLC19 had the privilege of being decided through the Taiwanese FDA and the Drug Assessment Center (CDE) for its “CDE Can Help: CoVID-19 Project – Regulatory Science Consultation Program” and was able to hold several consultation meetings with the CDE prior to the IND filing. The CRC also recommended ongoing communications once the assignment entered the clinical phase to ensure the maximum effective progression plan and regulatory pathway to increase the likelihood of success.
“Thanks to the recommendation and help of the CDE, TLC can temporarily complete the presentation of IND. We look forward to the immediate publication of a Phase I clinical trial to recruit fit volunteers in Taiwan to gather knowledge on pharmacokinetics and protection in a new liposome. formulas with the new inhalation pathway. Knowledge of this trial will serve as a forged basis for estimating the next dose in COVID-19 patients, who will be the subjects of our Phase II/III clinical trials, which are expected to take a position in the United States and other countries affected at most by the pandemic,” said George Yeh, president of FTA. “TLC19 is given with a commercial portable nebulizer that is suitable for outpatient treatment of patients with mild COVID-19, or as pre- and post-exposure prophylaxis for high-risk equipment, such as physical health professionals (HCPs). If the clinical effects are positive, TLC19 can serve as a practical transition strategy to fight the virus until an effective and safe vaccine is obtained worldwide and in a common way”.
TLC19 obtains active pharmaceutical ingredients from a U.S.-registered manufacturer DMF, CEP, Canadian DMF and GMP and its liposome formulas from a PIC/S GMP compliant facility that can be expanded to meet advertising demands.
About TLC
TLC (NASDAQ: TLC, TWO: 4152) is a clinically specialized pharmaceutical company committed to researching and creating a diversified portfolio of absolute ownership of new nanomedications that maximize the prospects of its lipid assembly drug delivery platform (LipAD ™), which incorporates BioSeizer ® and NanoX active drug loading generation ™ Array, which are flexible by opting for active and scalable pharmaceutical ingredients in manufacturing.
Caution on forward-looking statements
This press release forward statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this press release include, but are not limited to, statements relating to TLC’s expectations related to the clinical progression of TLC candidate products, adding candidate FTA products, the clinical benefits of FTA candidate products, timing, scope, progress and effects of FTA clinical trials , the point of money and sufficient equivalents to finance the operations. progress in FTA’s production capabilities. Words such as “possibly,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend, and similar expressions (as well as other words or words that refer to occasions and situations or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not promises of long-term functionality and involve a number of dangers, assumptions, doubts, failures and factors, adding the dangers that the final results of any clinical trial will be inherently doubtful and that candidate products possibly or possibly would. harmful or ineffective. download approval announcements and delays or interruptions in our operations or clinical trials due to the COVID-19 pandemic. Other hazards are described in the Risk Factors segment of the FTA Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission (the “SEC”) and in upcoming filings with the SEC. All forward-looking statements are based on FTA’s expectations and assumptions as of the date of this press release. Actual effects may differ materially from such forward-looking statements. Unless required by law, TLC expressly waives any duty to update any forward-looking statements contained herein, whether as a result of new information, long-term occasions or otherwise.