A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome

To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

开始日期2013-12-01

申办/合作机构

Rhodes Pharmaceuticals LP

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100 项与 PG-101 相关的临床结果

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100 项与 PG-101 相关的转化医学

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100 项与 PG-101 相关的专利（医药）

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项与 PG-101 相关的文献（医药）

2006-01-01·Biochemical and Biophysical Research Communications3区 · 生物学

Control of cytokine gene expression by PG101, a water-soluble extract prepared from Lentinus lepideus

3区 · 生物学

Article

作者: Yong-il Park ; Wi Young Lee ; Yong Nam Han ; Jeong June Choi ; Sunyoung Kim ; Jong Kyu Lee ; Mirim Jin

A water-soluble extract from Lentinus lepideus mycelium, named PG101, has been shown to control the expression of various cytokines [M. Jin, H.J. Jung, J.J. Choi, H.Jeon, J.H. Oh, B. Kim, S.S. Shin, J.K. Lee, K. Yoon, S. Kim, Activation of selective transcription factors and cytokines by water-soluble extract from Lentinus lepideus, Exp. Biol. Med. (Maywood) 228 (2003) 749-758]. To understand its molecular mechanism(s), PG101-mediated activation of cytokines was studied at the RNA and protein levels. Results from Northern blot analysis indicated that the steady-state RNA levels of TNF-alpha and seven other cytokines were highly increased in human peripheral blood mononuclear cells treated with PG101. The RNA level of TNF-alpha, MIP-1alpha, MIP-1beta, MIP-3alpha, and IL-8 was not affected by the presence of cycloheximide, an inhibitor of the translation process, suggesting that they are the direct targets of PG101. A significantly high protein level of TNF-alpha, MIP-1alpha, and IL-8 remained detectable, even when cells were cultured with actinomycin D, 2h prior to the PG101 treatment. Our data indicate that PG101 controls selective cellular proteins, which play key roles in the innate immune system, at the transcriptional and post-translational levels.

2003-06-01·Experimental Biology and Medicine4区 · 医学

Enhancement of Repopulation and Hematopoiesis of Bone Marrow Cells in Irradiated Mice by Oral Administration of PG101, a Water-Soluble Extract fromLentinus lepideus

4区 · 医学

Article

作者: Jeon, Hyang ; Kim, Bongcheol ; Kang, Chang-Yuil ; Kim, Sunyoung ; Jin, Mirim ; Lee, Jong Kyu ; Shin, Sung Seup ; Choi, Jeong June ; Jung, Hyung Jin

PG101 is a water-soluble extract from Lentinus lepideus. It is a potential biological response modifier that activates selective cytokines in vitro, mainly by controlling cellular transcription factor NF-κB. Effects of PG101 were tested on bone marrow cells in irradiated mice. Mice were irradiated with a dose of 6 Gy and were given PG101 by gavages daily for 24 days. In PG101-treated mice, the number of colony-forming cells, including colony-forming units (CFU)-granulocytes/macrophages (GM) and erythroid burst-forming units (BFU-E), were increased to almost the levels seen in nonirradiated control as early as 8 days after irradiation. Two-color flow cytometric analysis using antibodies to ER-MP12 and ER-MP20 suggested that in the bone marrow cell population, PG101 increased the number of granulocytes (ER-MP12-20med) and myeloid progenitors (ER-MP12+20+). Analysis of surface c-Kit and Gr-1 proteins in bone marrow cells indicated that PG101 might induce differentiation of progenitor cells to granulocytes and/or proliferation of the committed cells. Lastly, oral administration of PG101 highly increased serum levels of GM-CSF, IL-6, and IL-1β. Interestingly, the level of TNF-α was elevated by irradiation in control mice, but was maintained at the background level in PG101-treated mice, suggesting that PG101 might effectively suppress TNF-α-related pathologic conditions. Our results strongly suggest the great potential of PG101 as an immune enhancer during radiotherapy and/or chemotherapy.

2003-06-01·Experimental Biology and Medicine4区 · 医学

Activation of Selective Transcription Factors and Cytokines by Water-Soluble Extract from Lentinus lepideus

4区 · 医学

Article

作者: Choi, Jeong June ; Kim, Bongcheol ; Jeon, Hyang ; Oh, Jin Hwan ; Jung, Hyung Jin ; Kim, Sunyoung ; Shin, Sung Seup ; Jin, Mirim ; Yoon, Keejung ; Lee, Jong Kyu

We isolated a water-soluble extract, PG101, from cultured mycelia of Lentinus lepideus. Treatment of human peripheral blood mononuclear cells (PBMCs) with PG101 increased levels of TNF-α, IL-1β, IL-10, and IL-12 by 100- to 1000-fold, whereas GM-CSF and IL-18 were activated by an order of magnitude. On the contrary, IFN-γ and IL-4 were not affected. The response to PG101 occurred in a dose- and time-dependent manner. From the human PBMCs treated with PG101, TNF-α was a first cytokine to be activated, detectable at 2 hr post-treatment followed by IL-1β at 6 hr post-treatment. IL-12 and IL-10 were the next to follow. GM-CSF and IL-18 both showed significant increases 24 hr after treatment. When PBMCs were sorted into various cell types, monocyte/macrophages, but not T and B cells, were the major target cell type responsive to PG101. Consistent with this result, the profile of cytokine expression upon PG101 treatment was comparable between PBMCs and a human promonocytic cell line (U937), whereas cell lines of T cell and myeloid origins did not respond to PG101. Data from a transient transfection assay involving specific reporter plasmids indicated that cellular transcription factor such as NF-κB, but not AP-1, was highly activated by PG101. Results from a gel retardation assay and the experiment involving a specific NF-κB inhibitor confirmed the involvement of NF-κB. Despite its significant biological effect on various cytokines, PG101 remained nontoxic in both rats and PBMCs even at a biological concentration approximately 20 times greater. PG101 demonstrates great potential as a therapeutic immune modulator.

100 项与 PG-101 相关的药物交易

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