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Gradalis, Inc. Announces Presentation of New Data

June 18, 2014



DALLAS, June 18, 2014 (GLOBE NEWSWIRE) -- Gradalis Inc., a late-stage oncology therapeutic company, today announced that new data from its lead cancer programs focused on its personalized immunotherapy product were presented in May 2014 at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 17th Annual meeting of the American Society of Gene and Cellular Therapy (ASGCT).

At ASCO, safety and survival data were presented from a 3-year follow-up of 123 advanced cancer patients in a series of Phase 1 and Phase 2 studies, 64 of which had received the personalized immunotherapy and 53 who had not. Data demonstrated that the immunotherapy was well tolerated with only mild, local injection site adverse events. Survival benefit of those patients receiving the therapy was demonstrated and was correlated to T-cell activation against their tumor tissue. Randomized Phase 2 assessment is ongoing.1

Four posters were presented at ASGC involving separate patient populations.

The first poster included long term follow-up data from 74 advanced cancer patients with various tumors. Safety, T-cell activation and survival of patients were followed for over three years. The efficacy data suggested that T-cell activation against each patient's tumor initiated by the therapy correlated with patient survival justifying further efficacy testing. The Gradalis personalized immunotherapy continues to demonstrate no long-term toxicity profile with only minor injection site adverse events.2

The second poster included data in advanced hepatocellular patients and demonstrated that 3 of 5 patients receiving Gradalis' personalized immunotherapy mounted T-cell activation against their tumor tissue. Long-term follow up demonstrates survivals of 319, 729, 784, 931+ and 1043+ days of the immunotherapy treated patients. No toxicities were observed. These data justify advancement to a Phase 2 clinical study.3

In the third poster, data from a study of Gradalis' personalized immunotherapy in advanced Ewing's sarcoma was presented. Five pediatric patients had received the immunotherapy, three of whom experienced progressive disease. Two patients received 8 and 4 doses, respectively and both have stable disease. There have been no treatment-related serious adverse effects. This limited initial data shows the safety and feasibility of this study and possible clinical benefit.4

Also presented at ASGCT were preliminary Phase 2 data in high-risk Stage III/IV ovarian cancer. The majority of women with Stage III/IV ovarian cancer who achieve a complete clinical response with standard of care management involving debulking surgery and consolidation chemotherapy will relapse within 2 years. These data showed 92% of patients demonstrated T-cell activation against their tumor tissue as early as 1 month after initiation of immunotherapy and longer survival duration. Phase 2 accrual continues.5

"These presentations highlight data regarding Gradalis' innovative, personalized immunotherapy which demonstrated the promising significant therapeutic effect against a wide variety of cancers with no major adverse events," said Joseph M. Limber, President and Chief Executive Officer of Gradalis. "We believe that these data support the potential for Gradalis' personalized therapeutic to transform the way cancer is treated."

These data help form the basis for the Gradalis personalized immunotherapy planned Phase 3 program. That program currently focuses on the adjuvant treatment of patients with stage III/IV ovarian cancer after surgical debulking and five to six cycles of chemotherapy. There are currently no therapies approved for this setting. The ovarian cancer program is the first of several development directions employing this personalized immunotherapy. The other planned programs will be in the treatment of hepatocellular carcinoma, colorectal cancer with liver metastases, and Ewing's sarcoma.

About Gradalis

Gradalis is a fully integrated biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel personalized immunotherapies to treat cancer. Gradalis has its own GMP manufacturing facility along with highly skilled technical leadership and staff and a strategic partnership with Mary Crowley Cancer Research Centers for clinical development of Gradalis products.

For more information about Gradalis, Inc. please visit www.gradalisinc.com.

References

1 Nemunaitis J, et al. Survival effect of bi-shRNAfurin/GMCSF DNA-based immunotherapy (FANG) in 123 advanced cancer patients to alpha-interferon-ELISPOT response Abstract 3077 50th American Society of Clinical Oncology (ASCO) Chicago, IL

2 Nemunaitis J, et al. Long Term Follow Up: Phase I Trial of "bi-shRNA furin/GMCSF DNA/Autologous Tumor Cell" Immunotherapy (FANG™) in Advanced Cancer Abstract 619 17th Annual meeting of the American Society of Gene and Cellular Therapy (ASGCT) Washington, DC

3 Barve M, et al. Summary of bi-shRNAfurin/GM-CSF Augmented Autologous Tumor Cell Vaccine (FANG™) in Advanced Cancer of the Liver Abstract 620 17th Annual meeting of the American Society of Gene and Cellular Therapy (ASGCT)Washington, DC

4 Ghisoli M, et al. Phase I Study of FANG™ Vaccine in Advanced Ewing's Sarcoma Abstract 621 17th Annual meeting of the American Society of Gene and Cellular Therapy (ASGCT)Washington, DC

5 Oh J, et al. Randomized Phase II Trial of Adjuvant Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer: Preliminary Results Abstract 624 17th Annual meeting of the American Society of Gene and Cellular Therapy (ASGCT)Washington, DC

 

CONTACT: Beth Kriegel Vice President, Finance (214) 442-8156

Source: Gradalis, Inc.


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