Friday, October 12, 2012

Rose Bengal sustains high response rate in Melanoma patients!!!

According to a report on the abstract "Immuno-chemoablation of metastatic melanoma with intralesional Rose Bengal" by Agarwala, Thompson and Smithers in Ecancer news, Oct. 8, 2012:

Injecting cutaneous melanoma sites of stage III-IV patients with PV-10 (Rose Bengal) delivered sustained high response rates, reports an open label phase 2 study....It also revealed an additional 'bystander' effect in nearby non injected lesions.  Rose Bengal is a derivative of fluorescein, an agent that has been used for over 80 years to stain necrotic tissue in the cornea and as an IV diagnostic of liver impairment.  Its novel use in melanoma was discovered by Provectus Pharmadeuticals Inc (Knoxville, TN) while exploring different formulations for use in photodynamic cancer therapy.  By serendipity the company discovered that PV-10, a formulation developed to be administered directly into solid tumors, destroyed tumors without the need for light activation....[Of course,] the approach is only applicable to a subset of melanoma patients with cutaneous accessible disease.

In this Phase  2 single arm trial, 80 patients with stage III-IV melanoma received up to four courses of PV-10 injected into up to 20 cutaneous and subcutaneous lesions.  For each, a bystander lesion was identified that underwent biopsy to confirm melanoma, but did not undergo injection.  Patients were treated at seven centers in Australia and the USA.

Results:  Objective response was achieved in 51% of target lesions (25% complete response and 26% partial response).  Furthermore, disease control (combined Complete, Partial, and Stable responses) was achieved in 69% of lesions.  In bystander lesions: 33% = objective response and 50% achieved disease control in these lesions.

Overall survival: Stage III patients achieved a mean overall survival of at least 12.6 months versus 7.3 months for Stage IV.  

According to Dr. Agarwala, "These results confirm the robust response that can be achieved with PV-10 that was first seen in a preliminary report presented in 2010 in 20 patients."

It was also noted on MRI of 2 patients in the study that there was regression of lung mets.  "These were small lesions. It was an interesting observation but we will need a randomized study to demonstrate the effect," said Dr. Agarwala.

A Phase 3 randomized control trial, with 180 subjects with Stage III-IIIC melanoma, randomized to PV-10 or systemic chemotherapy is expected to start in early 2013 at centers in Australia, the US, and the EU.  Dr. Agarwala noted that Rose Bengal was likely to be used in combination with other agents, such as ipi and vemurafenib.  'Additionally, injection with PV-10 could be used as an adjunctive treatment to trigger an immune response prior to surgical removal of the tumors," said Dr. Agarwala.

And, to think!!!!  I place fluorescein in some kid's eyeball at least once a month to check to see if they have a corneal abrasion from strange kiddie activities involving various sports or disasters like: "my sister poked me in the eye with her straw!"  Perhaps, I should have been rubbing it over my skin.  I would be the color of a pumpkin with liver disease and glow in presence of a black light, but hey!  I'd be ready for Halloween!!! - c


  1. I've not heard of that one! But that's great ~ adds to the arsenal! And maybe every time you give an injection of this stuff, give yourself a little poke!

  2. Well, in the eye, to check for a corneal abrasion, the fluorescein comes on a little paper stick which you are to touch to the patient's eye...but I have my own technique. I place a drop of sterile water or saline over the stick as I hold it above the eye. Thereby making a nice little drop of the drug without having to poke someone in the eye!!! I should patent this!!! Anyhow, you then examine the eye using ultraviolet light, and a corneal abrasion shows up as a green pattern on the eye. I always let the kids look at themselves with a mirror since under the light their eye is drippy with a glow-in-the-dark sort of yellow green highlight in their lashes and all around. It makes it a little more fun!

  3. That is a great idea! You really should patent it!

  4. AND discovered in Knoxville TN. That's cool.