Tumor Targeted Immuno-Chemotherapy with Hapten Extends Median Survival Time from 6.45 Months to 15.5 Months for Advanced Pancreatic Cancer

Trial Supports Tumor Targeted Immuno-Chemotherapy with Hapten for Extending Median Survival Time for Pancreatic Cancer Patients

BEIJING, CHINA / ACCESSWIRE / April 28, 2016 / Principle Investigator Baofa Yu, M.D. of Beijing Baofa Cancer Research Center, announced results of a clinical study using several cytotoxic drugs with hapten, to enhance therapeutic effects for advanced pancreatic cancer patients. The study uses an ultra-minimally invasive tumor targeted immuno-chemotherapy protocol developed by Dr. Yu.

The patients selected were diagnosed with at least one solid pancreatic tumor at least 1.5 cm in diameter, confirmed malignant by CT, biopsy and pathology. Patients had locally advanced and/or metastatic tumors which had failed past conventional therapy. The patients were studied from November 1999 to August 2012 in a total of 86 cases.

In the December 2015, Journal of Liver Research, Disorders & Therapy, in a study using double drugs, 41 pancreatic cancer patients were divided randomly into two groups; SonataPlus-D (n = 30), treated with a proprietary therapeutic regiment consisting of two cytotoxic drugs (Cytosine Arabinoside, "Ara-C", and Bleomycin, "BLM"), an oxidant and hapten, and Sonata-D (n=11) with the same regiment as SonataPlus-D, but without hapten.

With a single drug, 45 pancreatic cancer patients were divided randomly into two groups; SonataPlus-S (n=25), using the same protocol as SonataPlus-D but with a single cytotoxic drug (Ara-C), an oxidant and hapten, and Sonata-S (n=20) using a single cytotoxic drug (Ara-C), an oxidant, but without hapten. Both the SonataPlus and Sonata groups used identical clinical procedures.

For the single drug, median survival was 6.45 months for SonataPlus-S versus 4.98 months for Sonata-S with a 1-year survival of 28% for SonataPlus-D versus 5% for Sonata-S.

However, with double drugs introduced, median survival increased significantly from 3 months for SonataPlus-S to 15.5 months for SonataPlus-D. The 6-month survival rate was 76.67% for SonataPlus-D versus 18.18% for SonataPlus-S with a 1-year survival rate of 56.67% for SonataPlus-D versus 9.09% for Sonata-S.

The study confirmed that SonataPlus is a minimally invasive and potentially effective therapy for treating advanced pancreatic cancer, and when double cytotoxic drugs with hapten were introduced, significant advantage prolonging the survival time for pancreatic cancer patients.

The protocol relies on a sustained release technology which combines FDA-approved oxidants with select chemo medicines, and are then injected directly into the tumor once a week for three consecutive weeks, where its stays for several weeks; providing up to a 95% efficacy over conventional chemo therapy protocols.

According to Dr. Yu, results of the study showed that when slow released chemo drugs combined with hapten were injected directly into the tumor, a potential "anti-cancer vaccine" was introduced which has been shown to deter and/or hamper potential cancer metastasis. In this study, treatment dosages were based upon tumor-size and inclusion of patient-specific autologous tumor antigens so as to induce a favorable self-vaccination tumor-specific response.

Tumor-targeted drug delivery has been known for decades. Some successful examples have shown the clinical feasibility of such treatment options, showing a significant reduction in toxicity and tumor growth, but not in pancreatic cancer patients. Pancreatic cancer is located in a crucial organ surrounded by vital tissues and organs such as the duodenum, gallbladder, portal vein, and aorta. Tumor invasion of these organs by pancreatic cancer is most common and can generally lead to unresectability

Pancreatic cancer with a 6% five year survival rate and a median survival time of 6-9 months, remains one of the most malignant and aggressive cancers in the world. It is the 10th most commonly diagnosed cancer, and 4th leading cause of cancer death in the U.S. In 2015 approximately 48,960 people were diagnosed with this malignancy, with 40,560 attributed deaths during that period.

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