A Phase 2 Randomised, Double-blind, Placebo Controlled, Study of MR901 in Patients With Moderate to Severe Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

This study investigates the safety and efficacy of a photosensitive drug (talaporfin sodium) activated by an intraurethrally placed drug-activating device. MR901 is a code used to identify the combination of talaporfin sodium and the drug-activating device. Two different light doses will be tested against placebo groups in this 4-arm study.

Start Date01 Nov 2014

Sponsor / Collaborator

Light Sciences Oncology, Inc.

[+1]

NCT00918034 / CompletedPhase 2

A Phase 2 Study to Evaluate the Safety and Effectiveness of Using the Litx™ BPH System in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) Who Are Candidates for Interventional Therapy

This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).

Start Date01 May 2009

Sponsor / Collaborator

Light Sciences Oncology, Inc.

EUCTR2007-004795-39-IT / Not yet recruitingNot Applicable

A PHASE 3 RANDOMIZED STUDY TO EVALUATE SURVIVAL OF PATIENTS TREATED WITH TALAPORFIN SODIUM (LS11) AND INTERSTITIAL LIGHT EMITTING DIODES (LED) AS COMPARED TO THE STANDARD OF CARE THERAPIES IN THE TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) - ND

Start Date17 Jul 2008

Sponsor / Collaborator

Light Sciences Oncology, Inc.

100 Clinical Results associated with Light Sciences Oncology, Inc.

0 Patents (Medical) associated with Light Sciences Oncology, Inc.

Literatures (Medical) associated with Light Sciences Oncology, Inc.

01 Jan 2011·Journal of Cancer Therapy

Tumor Resistance to Molecularly Targeted Agents

Author: Edelstein, Peter S. ; Lustig, Robert ; Chen, James ; Ooi, Lucien ; Johnson, Philip J.

A review.Despite the development of new targeted cancer therapies, primary and secondary tumors continue to be a leading cause of suffering and mortality worldwide.The complexity and heterogeneity of malignancies ultimately result in tumor resistance to therapies, such as EGFR inhibitiors, anti-angiogenesis agents, and tyrosine kinase inhibitors.An example of targeted therapies for renal cell carcinoma is presented, including the SAE profile and efficacy of 6 targeted agents.Although survival is improved, resistance and an increased side effect profile diminish the benefits of these agents.New agents are needed which are pathway independent and which can overcome tumor resistance without adding to the side effect profile of current therapies.

01 Jan 2010·Expert Opinion on PharmacotherapyQ3 · MEDICINE

Talaporfin sodium

Q3 · MEDICINE

Review

Author: Bromley, Elizabeth ; Keltner, Llew ; Xu, Leon ; Wang, S. ; Chen, James C.

IMPORTANCE OF THE FIELDDespite therapeutic advances, cancer remains the cause of an estimated 23% of deaths in the USA. New treatments for malignancy are greatly needed.AREAS COVERED IN THIS REVIEWTalaporfin sodium is a light-activated drug that causes tissue death through induction of apoptosis. Systemic antitumor effects mediated by CD8(+) T cells have been demonstrated in preclinical studies, providing a mechanism for distant response of tumors noted in clinical trials. Talaporfin sodium is approved in Japan for early-stage endobronchial cancer. Phase I and II studies in solid tumors have shown tumor regression in patients refractory to other therapies. Phase III pivotal studies against hepatocellular carcinoma as monotherapy and liver-metastatic colorectal cancer in combination with chemotherapy are ongoing. Talaporfin sodium is also in studies in men with symptomatic benign prostatic hyperplasia. Substantial safety data from clinical trials so far indicate that the drug is well tolerated.WHAT THE READER WILL GAINTalaporfin sodium has a broad safety profile and a mode of action that could affect growth in treated and untreated tumors.TAKE HOME MESSAGEClinical and preclinical studies indicate that talaporfin sodium treatment may offer a powerful option to synergize current therapies, as well as an alternative monotherapy in treating cancer.

20 May 2009·Journal of Clinical Oncology

A phase I/II safety and efficacy study of intratumoral light-activated drug therapy using talaporfin sodium in patients with inoperable hepatocellular carcinoma

Author: Keltner, L. ; Winship, J. ; Lee, W. ; Wang, S.

e15684 Background: Light Infusion Therapy™ (Litx™) consists of the light-activated drug, talaporfin sodium (LS11®; mono-L-aspartyl chlorin e6), activated by a single-use, disposable device with an array of light-emitting diodes (LEDs). We evaluated talaporfin in combination with the light source in a phase 1/2 safety and efficacy trial in patients with hepatocellular carcinoma (HCC). To the best of our knowledge, this is the first clinical study of light-activated drug therapy in patients with HCC. Methods: Patients had confirmed primary HCC, 1–3 liver lesions, an ECOG score of 0–2, and a life expectancy of at least 16 weeks. Prior treatment failure with locally ablative techniques was allowed. The light-activated drug used in the study was talaporfin, a semi-synthesized, water-soluble chlorin e6 derivative. The LED device used in this study was a 1.5 mm diameter linear array of LEDs with a 25 mm emitting length at a wavelength of 664 nm. Patients underwent image-guided percutaneous placement of 1–4 LED device(s) using either local anesthesia or conscious sedation. The LED devices were used in single lesions or in multiple lesions. Following intratumoral placement of the LED devices, patients received talaporfin at 1 mg/kg IV bolus. Delivery of light energy commenced 15 min to 1 hr following drug administration with a total illumination time of 2.8 hrs. Results: The enrolled study group consisted of 8 patients. All 8 patients completed the week 4 assessment and were evaluated for tumor response. One (12.5%) out of 8 patients in this study was reported to have a complete response at week 4. Five patients (62.5%) were reported to have stable disease, and another 2 patients (25%) showed progressive disease. During the study, 7 patients reported a total of 16 treatment-related adverse events. There were no treatment-related adverse events that were greater than grade 2. At 1 year post treatment, all patients were alive. Conclusions: The results from this phase 2 study demonstrated that the therapy was safe for the treatment of HCC. A subsequent randomized controlled phase 3 pivotal trial is nearing completion and is designed to prove efficacy in patients with inoperable HCC. [Table: see text]

100 Deals associated with Light Sciences Oncology, Inc.

100 Translational Medicine associated with Light Sciences Oncology, Inc.

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Drug(Targets)	Indications	Global Highest Phase

LS-216	Neoplasms More	Discontinued
Talaporfin Sodium	Dystrophy, Macular More	Discontinued

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