Senseco Releases Optimistic Data from Third Cohort in Blood Cancer Clinical Trial

Senseco Releases Optimistic Data from Third Cohort in Blood Cancer Clinical Trial

By: Tomas Ronolski - AllPennyStocks.com News

Monday, December 9, 2013

Lymphona is the most common type of blood cancer, occurring when lymphocytes, a type of white blood cell, multiply and grow uncontrollably. There are two main types of lymphocytes, B-cells and T-cells, which can develop into one of two primary types of lymphoma, Hodgkin and non-Hodgkin, and spread to various parts of the body. The most common form of non-Hodgkin lymphoma (NHL) is diffuse large B-cell lymphoma, accounting for nearly one-third of newly diagnosed NHL cases. In the United States alone, there are about 120,000 cases of diffuse large B-cell lymphoma. Blood-borne cancers are the focus of Senesco Technologies, Inc. (OTCQB:SNTI) with its flagship therapeutic SNS01-T. The company’s gene regulation technology is comprised of three components: a DNA plasmid, a small inhibitory RNA (siRNA) and polyethylenimine, which cumulatively work to target damaged cancerous cells and destroy them.


Pre-clinical research showed SNS01-T combined with Celgene’s (Nasdaq:CELG) lenalidomide (Revlimid) outperformed lenalidomide alone in mouse models of multiple myeloma. Lenalidomide is a derivative of thalidomide that is commonly used to treat blood cancers. In the study, implanted myeloma tumors were eradicated after a single six-week dose cycle of the combination in 67 percent of the mice, with no regrowth after two months without treatment. All the mice in the study lived 102 days to the conclusion of the trial.

In addition to greater efficacy, an improved safety profile related to Revlimid is very desirable. Celgene was forced to halt a Phase III trial earlier this year after testing Revlimid as a new therapy for older patients with B-cell lymphocytic leukemia because of an increased risk of death.

Senesco has taken their drug candidate to the clinic, sponsoring trials that are being hosted at several prominent cancer research sites, including the Mayo Clinic in Rochester, Michigan. The company reported on Friday that it has reported results from the third cohort in the Phase 1b/2a clinical study as the 55th American Society of Hematology Annual Meeting in New Orleans.

In the third cohort, two patients with diffuse large B-cell lymphoma (DLBCL) and two patients with multiple myeloma completed treatment at a dosage of 0.2 mg/kg. All of the patients had failed previous treatments in one manner or another. One of the patients was not evaluable because of a dose reduction due to a pre-existing condition of low blood platelets.

Evaluation of the cohort showed no dose-limiting toxicities and a growing positive safety profile for SNS01-T with minimal and manageable side effects.

“In addition to the absence of dose-limiting toxicity, since all patients in cohort 3 completed the full protocol-specified 6-week treatment period, we appear to be seeing longer treatment durations and fewer dropouts compared to cohorts 1 and 2,” said Alice S. Bexon, M.D., Vice President of Clinical Development at Senesco, in a statement today.

Seeing efficacy in early stages can often be an anomaly in clinical trials, but data is suggesting that the drug is having a clinical benefit. According to the company, “One myeloma patient had reductions in disease-related proteins in his blood and a second patient with DLBCL had evidence of tumor shrinkage in some lesions” and “Upon treatment with SNS01-T, three of the four patients exhibited stable disease at week 3 and two of the four were stable at week 6, the end of treatment.”

The Data Review Committee has reviewed the data from the third cohort and has recommended dose escalation in the fourth cohort to 0.375 mg/kg. It was at this dosing level in animal models during pre-clinical research that tumor shrinkage was observed.

Senesco is expecting to report results from the highest dosing level as set forth by the clinical trial protocol in mid-2014.

Maybe a bit surprisingly, shares of SNTI are trading down in Monday action, following the news. It is notable that there are minimal outstanding shares (15.34 million) since the company did a 1-for-100 reverse split in October. With about 20 percent of the shares held by insiders, the float is small, which can often lead to some volatile trading on negligible volume. Shares are down 11 percent today at $4.85 with 54,000 shares changing hands as the day winds to a close.

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