Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator

This study is the first step in testing the hypothesis that adding Photobac® Photodynamic Therapy to surgical removal of a glioblastoma or gliosarcoma will be both safe and effective.
Photodynamic Therapy (PDT) combines light and a photosensitizer. PDT has been used to treat a variety of cancers with varying degrees of success.
For the past thirty years Photolitec has been working to develop a treatment for glioblastoma or gliosarcoma using light and a photosensitizer. Photolitec's scientists were looking for a photosensitizer that:
has no significant systemic toxicity apart from some temporary skin photosensitivity,
crosses the blood brain barrier,
accumulates to a high level in glioblastoma and minimally in the brain,
is activated by the wavelength of light that penetrates most deeply into the brain,
minimizes any temporary skin photosensitivity.
Preliminary testing indicates the Photolitec team has achieved these five goals. Photolitec is now able to offer a clinical trial based on the results of this work.

开始日期2023-04-11

申办/合作机构

Photolitec LLC

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100 项与 Photobac 相关的临床结果

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100 项与 Photobac 相关的转化医学

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100 项与 Photobac 相关的专利（医药）

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项与 Photobac 相关的文献（医药）

2023-12-01·Biomedicine & Pharmacotherapy

Photobac derived from bacteriochlorophyll-a shows potential for treating brain tumor in animal models by photodynamic therapy with desired pharmacokinetics and limited toxicity in rats and dogs

Article

作者: Bshara, Wiam ; Dukh, Mykhaylo ; Spernyak, Joseph A ; Turowski, Steven G ; Pandey, Ravindra K ; Curtin, Leslie ; Cacaccio, Joseph ; Sexton, Sandra ; Durrani, Farukh A

Photobac is a near infrared photosensitizer (PS) derived from naturally occurring bacteriochlorophyll- a, with a potential for treating a variety of cancer types (U87, F98 and C6 tumor cells in vitro). The main objective of the studies presented herein was to evaluate the efficacy, toxicity and pharmacokinetic profile of Photobac in animals (mice, rats and dogs) and submit these results to the United States Food and Drug Administration (US FDA) for its approval to initiate Phase I human clinical trials of glioblastoma, a deadly cancer disease with no long term cure. The photodynamic therapy (PDT) efficacy of Photobac was evaluated in mice subcutaneously implanted with U87 tumors, and in rats bearing C6 tumors implanted in brain. In both tumor types, the Photobac-PDT was quite effective. The long-term cure in rats was monitored by magnetic resonance imaging (MRI) and histopathology analysis. A detailed pharmacology, pharmacokinetics and toxicokinetic study of Photobac was investigated in both non-GLP and GLP facilities at variable doses following the US FDA parameters. Safety Pharmacology studies suggest that there is no phototoxicity, cerebral or retinal toxicity with Photobac. No metabolites of Photobac were observed following incubation in rat, dog, mini-pig and human hepatocytes. Based on current biological data, Photobac-IND received the approval for Phase-I human clinical trials to treat Glioblastoma (brain cancer), which is currently underway at our institute. Photobac has also received an orphan drug status from the US FDA, because of its potential for treating Glioblastoma as no effective treatment is currently available for this deadly disease.

1988-03-01·Research communications in chemical pathology and pharmacology

Pharmacokinetics of a new inotropic catecholamine in dog plasma using solid phase extraction technology.

Article

作者: Hsiao, J ; Dixon, R ; Caldwell, W

The pharmacokinetics of a new inotropic catecholamine, N-[2-(3,4-dihydroxyphenyl)-ethyl]-1-methyl-3-(3-carbomylphenyl)-pr opylamine HCL (KM-13), was studied following i.v. injection of 50 and 100 micrograms/kg doses to dogs. KM-13 was extracted from plasma using Bond-Elut CN columns and quantitated by HPLC with electro-chemical detection. The plasma concentration--time profile of KM-13 following an i.v. bolus was best fitted with a bi-exponential equation and the terminal elimination phase had a half life of about 20 min. The analytical method, with a limit of sensitivity of 2 ng/ml, would appear to have general applicability in studying the pharmacokinetics of synthetic catecholamines.

100 项与 Photobac 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
多形性胶质母细胞瘤	临床1期	美国	Photolitec LLC	2023-04-11
神经胶质肉瘤	临床1期	美国	Photolitec LLC	2023-04-11
复发性胶质母细胞瘤	临床1期	美国	Photolitec LLC	2023-04-11
胶质母细胞瘤	临床申请	美国	Ami Onco-Theranostics LLC初创企业	2022-08-11
膀胱癌	临床前	美国	Ami Onco-Theranostics LLC初创企业	2022-08-11