Jul 11, 2017
TLC Announces Issuance of Patents for Three Product Candidates
TLC (4152:TT) today announced that the U.S. Patent and Trademark Office has issued a patent (Reference No.: 9700511) entitled “Controlled Drug Release Liposome Composition”, which provides coverage for the company’s product candidate TLC178. The same patent will also be officially issued by the Taiwan Intellectual Property Office later this month. Two more patents – one relevant to the company’s knee osteoarthritis product candidate TLC599 in the U.S. and another relevant to its macular edema product candidate TLC399 in Australia – have been issued the notice of allowance/acceptance this year.
TLC178 is a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine that applies the NanoX™ nanotechnology platform to decrease toxicity and reduce side effects. These capabilities are likely to expand the drug’s applications from the current vinorelbine indication of non-small cell lung cancer to lymphomas such as non-Hodgkin’s and other advanced solid tumors such as soft-tissue sarcoma. TLC178 was recently granted an orphan drug designation for the treatment of cutaneous T-cell lymphoma by the U.S. Food and Drug Administration, who also designated the same drug for a rare pediatric disease in the treatment of rhabdomyosarcoma, a type of soft-tissue sarcoma. A Phase 1/2 dose-escalation study of TLC178 is currently underway at sites in Taiwan and the U.S. to evaluate the maximum tolerated dose (MTD). Once established, the MTD will be used in pivotal studies.
“TLC currently has over 100 patents under review and granted, signifying our resolve to not only be progressive in our pipeline but also in our intellectual property assets,” said George Yeh, President of TLC. “These new patents, including the ones for our knee osteoarthritis drug and macular edema drug, are significant milestones as they position TLC as a key player in the oncology, ophthalmology and pain management space, which are our key areas of focus.”
In addition to the patents relevant to TLC178, the company has also received this year notices of allowance/acceptance for patents entitled “Methods of Treating Arthritis” from the U.S. relevant to the candidate TLC599 and “Pharmaceutical Compositions to Reduce Complications of Ocular Steroid” from Australia relevant to the candidate TLC399.
TLC599 and TLC399 are injectable formulations of liposomal dexamethasone encapsulated with the company’s proprietary BioSeizer™ technology to treat knee osteoarthritis and macular edema, respectively. TLC is currently recruiting patients for the TLC599 Phase 2 clinical trial at sites in Australia and Taiwan, and the TLC399 Phase 2 clinical trial in numerous states in the U.S. For more information on these trials, please visit the websites below:
A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee
https://clinicaltrials.gov/ct2/show/NCT03005873
TLC399 in Subjects with Macular Edema Due to Retinal Vein Occlusion (RVO)https://clinicaltrials.gov/ct2/show/study/NCT03093701
Source：Taiwan Liposome Company, Ltd.
http://www.tlcbio.com/en-global/MediaDownloadContent/media_download/Content/88
TLC178 is a liposomal-encapsulated formulation of the chemotherapy drug vinorelbine that applies the NanoX™ nanotechnology platform to decrease toxicity and reduce side effects. These capabilities are likely to expand the drug’s applications from the current vinorelbine indication of non-small cell lung cancer to lymphomas such as non-Hodgkin’s and other advanced solid tumors such as soft-tissue sarcoma. TLC178 was recently granted an orphan drug designation for the treatment of cutaneous T-cell lymphoma by the U.S. Food and Drug Administration, who also designated the same drug for a rare pediatric disease in the treatment of rhabdomyosarcoma, a type of soft-tissue sarcoma. A Phase 1/2 dose-escalation study of TLC178 is currently underway at sites in Taiwan and the U.S. to evaluate the maximum tolerated dose (MTD). Once established, the MTD will be used in pivotal studies.
“TLC currently has over 100 patents under review and granted, signifying our resolve to not only be progressive in our pipeline but also in our intellectual property assets,” said George Yeh, President of TLC. “These new patents, including the ones for our knee osteoarthritis drug and macular edema drug, are significant milestones as they position TLC as a key player in the oncology, ophthalmology and pain management space, which are our key areas of focus.”
In addition to the patents relevant to TLC178, the company has also received this year notices of allowance/acceptance for patents entitled “Methods of Treating Arthritis” from the U.S. relevant to the candidate TLC599 and “Pharmaceutical Compositions to Reduce Complications of Ocular Steroid” from Australia relevant to the candidate TLC399.
TLC599 and TLC399 are injectable formulations of liposomal dexamethasone encapsulated with the company’s proprietary BioSeizer™ technology to treat knee osteoarthritis and macular edema, respectively. TLC is currently recruiting patients for the TLC599 Phase 2 clinical trial at sites in Australia and Taiwan, and the TLC399 Phase 2 clinical trial in numerous states in the U.S. For more information on these trials, please visit the websites below:
A Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for Single Dose Administration of TLC599 in Patients with Osteoarthritis (OA) of Knee
https://clinicaltrials.gov/ct2/show/NCT03005873
TLC399 in Subjects with Macular Edema Due to Retinal Vein Occlusion (RVO)https://clinicaltrials.gov/ct2/show/study/NCT03093701
Source：Taiwan Liposome Company, Ltd.
http://www.tlcbio.com/en-global/MediaDownloadContent/media_download/Content/88