Navigation Links
Provectus Pharmaceuticals, Inc. releases summary results of phase 1 metastatic melanoma study
Date:9/18/2007

KNOXVILLE, Tenn.--Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) announced preliminary results of its Phase 1 clinical trial of Provecta for the treatment of metastatic melanoma, the most aggressive form of skin cancer. Provecta demonstrated minimal side effects, significant efficacy and bystander effect on melanoma tumors in stage III patients. The study evaluated safety and efficacy of Provecta in a total of 20 subjects at two sites in Australia.

In the study, Provecta was injected once into one to twenty tumors in each subject. In addition to these treated tumors, an additional one to three tumors were left untreated in each subject to allow assessment of a potential "bystander effect" resulting from immune system response to tumor treatment. A total of 114 tumors were injected and 39 bystander tumors were observed in the study. Subjects were followed for 4 to 27 weeks. Study treatments were well tolerated and elicited minimal side effects, the most common being mild to moderate pain at the injection site.

Results for all evaluable tumors were tabulated using the RECIST (Response Evaluation Criteria in Solid Tumors) approach, which objectively grades response for each subject based on change in the sum of the longest diameter for each of the subject's tumors vs. baseline. Subject outcome was scored in terms of complete response (CR -- complete tumor disappearance or negative histopathology), partial response (PR -- 30% or more tumor shrinkage), stable disease (SD -- 29% shrinkage to 20% growth), and progressive disease (PD -- greater than 20% growth).

At final evaluation after injection with a single dose of Provecta, the following results were obtained: 20% of subjects achieved CR of their injected tumors, 20% achieved PR, 35% achieved SD and 25% achieved PD, corresponding to an objective response (CR+PR) in 40% of subjects and local disease control (CR+PR+SD) in 75% of subjects. Among those subjects achieving an objective response of their treated tumors, 25% achieved an objective response of their untreated bystander tumors, and 100% exhibited disease control in their bystander tumors. In contrast, for those subjects failing to achieve an objective response of their treated tumors, only 8% achieved an objective response of their bystander tumors, and 92% exhibited progressive disease in their bystander tumors. These differences in response of bystander lesions as a function of response of target lesions were statistically significant and support the occurrence of a bystander effect in subjects whose target lesions have been responsive to PV-10 chemoablation.

Craig Dees, Ph.D., Chief Executive Officer of Provectus stated, "While full analysis of our phase 1 data is yet to be completed and will be reported by other means, the significance of these top line numbers is compelling and serves to illustrate the unique properties of Provecta. Additionally, they reinforce the confidence level we've had since we first witnessed the effects of this drug for the treatment of melanoma. These results have motivated us to put forth an aggressive clinical plan designed to drive toward approval of Provecta for this devastating disease." Dees continued, "The response from the body's own immune system to those tumors that were left untreated makes our novel approach to treating the disease that much more attractive."


'/>"/>

Contact: Janet Vasquez
212-825-3210
Provectus Pharmaceuticals
Source:Eurekalert

Related medicine news :

1. Sweet corn releases antioxidants on cooking
2. An International Growth Standard For Childs Releases By WHO
3. The National Governors Association Releases Guidelines For Outbreak Of Bird Flu
4. Eli Lilly Releases Digital Insulin Pen
5. Experimental treatment for Ebola Virus Shows promising results in mice
6. Hormone Deficiency Results In Miscarriage
7. Gleevec gets hopeful results
8. Breast Implants May Interfere With The Interpretation Of Mammogram Results
9. DNA Testing For More Accurate Results
10. Operating on a Beating Heart Yields Better Results For Blocked Heart Arteries
11. IVF results may be affected by stress and other related factors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ), one ... an innovative new design of the shoulder pad. The shoulder pad provides optimal ... controlling your pain while using cold therapy. By utilizing ice and water that is ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... system that we intend to develop to enable prevention of a major side ... severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... (HLA), the nation's first interactive health literacy software tool, and the Cancer Patient ... aspects of cancer patient education, today announce a new strategic alliance. , ...
(Date:10/12/2017)... Washington, D.C. (PRWEB) , ... October 12, 2017 ... ... Company, Cal Dining at the University of California Berkeley, and other leading institutions ... leverages the buying power of institutions to change the way animals are raised ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... ROCKVILLE, Md. , Sept. 22, 2017  As ... by Republican Senators Bill Cassidy (R-LA) and ... Kalorama Information notes that the medical device industry is ... the medical device tax, the 2.3% excise tax on ... Act.  But they also want covered patients, increased visits ...
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
(Date:9/12/2017)... MOUNTAIN LAKES, N.J. , Sept. 12, 2017  Consumer reviews ... Embrace Hearing as the number one company for hearing ... Oticon™, ReSound™ and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that ...
Breaking Medicine Technology: