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PR Newswire
SAN DIEGO, Sept. 25, 2012
SAN DIEGO, Sept. 25, 2012 /PRNewswire/ -- OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that it has established the University of Washington (UW) as the second enrolling site for its Phase II metastatic melanoma clinical trial (OMS-I100). Investigational Review Board (IRB) approval has been received by UW, and investigators are actively recruiting for this clinical trial.
(Logo: http://photos.prnewswire.com/prnh/20120905/LA68078LOGO)
"UW now joins the University of California, San Francisco, John Wayne Cancer Institute and Lakeland Cancer Center as our fourth site for the melanoma study," said Punit Dhillon, President and CEO of OncoSec. "We have enjoyed working with UW and Dr. Shailender Bhatia for the Merkel cell carcinoma program, and look forward to having them join the melanoma trial as well."
A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years for safety.
Dr. Shailender Bhatia, principal investigator at UW, commented "We have had experience with this treatment in the Phase II Merkel cell carcinoma study, so we are glad to have the opportunity to now offer this treatment as an experimental therapy to the patients who are suffering from melanoma."
ImmunoPulse utilizes OncoSec's proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12, or DNA IL-12. The OncoSec Medical System (OMS) applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells. Phase I data using ImmunoPulse to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53% of patients with distant metastatic lesions demonstrated an objective response, with 15% of these patients having a complete response to the treatment.
For more information about this trial visit: http://clinicaltrials.gov/ct2/show/NCT01502293.
San Diego’s OncoSec Medical is testing treatment that uses electronic pulses to activate fight against tumors
Comments ()Share:TweetFacebookEmailPrintSave By PADMA NAGAPPAN SPECIAL TO THE U-T
12:01 a.m., Oct. 3, 2012
Updated 7:09 p.m. , Oct. 2, 2012
CEO Punit Dhillon, 32, with an electroporator at OncoSec Medical. Nelvin C. Cepeda • U-t Late-stage skin cancers are typically treated with chemotherapy and surgery, but a San Diego company is focusing on a noninvasive approach that it says will improve the quality of life for patients.
OncoSec Medical is conducting Phase 2 clinical trials for a therapy called Immunopulse, which taps the body’s immune response to destroy cancer cells. By delivering short electrical pulses to the surface of a tumor, it targets the cells more accurately, boosting the effectiveness of the anti-cancer agent it delivers.
“I’ve watched this market and how you deliver drugs to tumors. Increasing the payload helps improve effectiveness, but it also increases toxicity. What this company is doing is targeting the localized tumor,” said Duane Roth, chief executive of Connect, the San Diego tech incubator that assisted OncoSec. “It’s ‘how do you increase the payload and get the immune system to respond.’ ”
With nearly $12 million in funding, OncoSec is conducting simultaneous Phase 2 clinical trials for Immunopulse for three types of cancer: metastatic melanoma, Merkel cell carcinoma and cutaneous T-Cell lymphoma. The three are less common than other skin cancers but are often drug-resistant and aggressive.
Immunopulse combines the electrical pulses, called electroporation, with gene therapy. The technology was developed by Inovio Pharmaceuticals in San Diego, which focuses on DNA-based vaccines for infectious diseases and oncology.
When the combination proved promising in skin cancers, it led to the formation of OncoSec in March 2011. Punit Dhillon, who was Inovio’s vice president of finance and operations, founded OncoSec, which acquired the rights to the technology and the device.
Dhillon’s uncle, Avtar Dhillon, current chairman of Inovio, is the company’s other co-founder.
Tap protein that kills cells Electroporation opens temporary pores in the cell membrane of infected cells, through which an anti-cancer agent can be transmitted more effectively. OncoSec’s therapy uses a gene that triggers secretion of a protein that targets and kills the cancerous cells.
Previously, researchers have introduced genes into tumors using viruses, but that technique has drawbacks, such as biohazard concerns, risk of spreading and immune response concerns.
“When you keep injecting viruses, then the immune system mounts an attack against the virus itself, so whatever gene you are introducing with the virus will have less chance of getting a response,” said Dr. Adil Daud, an oncologist who runs OncoSec’s clinical trial for metastatic melanoma and is a co-investigator in the other trials.
Electroporation does not have that issue, said Daud, who is co-director of the melanoma program at the University of California San Francisco.
“It’s a great modality for treatment. You inject the naked DNA or gene into the cell and get the gene to be expressed in that tumor so it gets an immune reaction and destroys the tumor,” he said.
The process of applying the electrical pulse can be unpleasant for patients, but the reaction recedes quickly, Daud said. Side effects are limited to fever, chills and possible minimal short-term pain.
Treatment can be given on an outpatient basis, with the process taking just a few minutes three times over eight days.
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PR Newswire
SAN DIEGO, Sept. 25, 2012
SAN DIEGO, Sept. 25, 2012 /PRNewswire/ -- OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced that it has established the University of Washington (UW) as the second enrolling site for its Phase II metastatic melanoma clinical trial (OMS-I100). Investigational Review Board (IRB) approval has been received by UW, and investigators are actively recruiting for this clinical trial.
(Logo: http://photos.prnewswire.com/prnh/20120905/LA68078LOGO)
"UW now joins the University of California, San Francisco, John Wayne Cancer Institute and Lakeland Cancer Center as our fourth site for the melanoma study," said Punit Dhillon, President and CEO of OncoSec. "We have enjoyed working with UW and Dr. Shailender Bhatia for the Merkel cell carcinoma program, and look forward to having them join the melanoma trial as well."
A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years for safety.
Dr. Shailender Bhatia, principal investigator at UW, commented "We have had experience with this treatment in the Phase II Merkel cell carcinoma study, so we are glad to have the opportunity to now offer this treatment as an experimental therapy to the patients who are suffering from melanoma."
ImmunoPulse utilizes OncoSec's proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12, or DNA IL-12. The OncoSec Medical System (OMS) applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells. Phase I data using ImmunoPulse to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53% of patients with distant metastatic lesions demonstrated an objective response, with 15% of these patients having a complete response to the treatment.
For more information about this trial visit: http://clinicaltrials.gov/ct2/show/NCT01502293.
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zuzüglich After Hours: 780 DOLLAR
PR Newswire
SAN DIEGO, Oct. 09, 2012
SAN DIEGO, Oct. 09, 2012 /PRNewswire/ -- OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapies to treat solid tumor cancers, announced the company will be presenting data at two upcoming medical conferences.
(Logo: http://photos.prnewswire.com/prnh/20120905/LA68078LOGO)
Dr. Shailender Bhatia, assistant professor at the University of Washington School of Medicine, will be presenting preliminary clinical data from OncoSec's ongoing Phase II Merkel cell carcinoma trial at the 27th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2012), October 26-28, 2012, at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.
The company will also be presenting preliminary clinical data from its ongoing Phase II metastatic melanoma trial to the 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress, November 14-17, 2012, at the Hotel Fira Palace in Barcelona, Spain.
Preliminary analyses of both the Merkel cell carcinoma and metastatic melanoma trials will be based on a subset of enrolled subjects, and will evaluate clinical response to at least one cycle of ImmunoPulse treatment.
At the Melanoma/EADO meeting on November 15 at 5:30 PM local Barcelona time, Adil I. Daud, M.D., co-director of melanoma clinical research at the University of California San Francisco's Helen Diller Family Comprehensive Cancer Center and lead investigator for OncoSec's metastatic melanoma trial, along with Axel Hauschild, M.D., professor of dermatology at the University of Kiel, will co-chair an OncoSec-sponsored symposium titled "Electrogenetherapy: Intralesional Immunotherapy Approach for Skin Cancers Using Electroporation."
The company will provide a complete summary of the data presented at both conferences in upcoming press releases.
About SITC 2012
The SITC Annual Meeting & Associated Programs serve as the premier destination for scientific exchange, education and networking in the cancer immunotherapy community. Basic researchers, clinicians, students, postdoctoral fellows and allied health professionals dedicated to improving cancer patient outcomes come together to experience cutting edge research, education and training that serves as the catalyst to advance the field.
About the 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress
The World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers is an opportunity for clinicians and researchers who are part of multidisciplinary melanoma centers can interact, learn from one another, establish collaborations and set an agenda for the further evolution of multidisciplinary melanoma care and research. The meeting has been combined with the EADO congress whose focus is on melanoma, cutaneous lymphoma and epithelial skin cancers and is specifically designed to attract young investigators and skin cancer-treating physicians in the field.
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec's core technology is based upon its proprietary use of an electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers. More information is available at http://www.oncosec.com/.
0.3195 0.0255 8.67 1,702,060 10/10/12 12:44:16 0.314 0.325 0.301