Senesco Technologies higher after FDA removes hold on new drug application
Senesco Technologies (AMEX:SNT) announced on Monday after hours that the Company had been told by the U.S. Food and Drug Administration that all clinical hold issues have been satisfactorily addressed and that regulators have now removed the clinical hold on Senesco’s Investigational New Drug application. On Monday, before the news hit- we told our premium subscribers that we had been hearing positive buzz about Senesco's clinical program and intra-day shares rose from $.26 at the time of our alert to as high as $.38 after-hours.
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As each year passes, over half a million men and women die from cancer in the United States, it’s apparent that a new approach to fight the disease is long overdue.
While there are many types of cancer, the ways that we can fight the disease are few, and these treatments seem little different than the barbaric bloodletting or bleeding of a patient that was often recommended by physicians before modern medicine. Radiation and chemotherapy, which are the current standard of care for cancer, essentially kill cells until the cancer can no longer be found in the body, with the hope that the body can withstand the treatment. New treatments for cancer are desperately needed, and one that may use the body’s natural processes through gene therapy may provide a window of opportunity for new treatment.
Certain aspects of gene therapy have been found to regulate cell death, and have been used to great effect for what seems like a simpler use, prolonging the shelf life of bananas. Apoptosis, or programmed cell death, is the vehicle that Senesco Technologies believes could be used to treat major medical conditions such as diabetes, cardiovascular disease and cancer.
Senesco Technologies (Amex:SNT) has recently been granted Orphan Drug Status and submitted their first Investigational New Drug application (IND) with the FDA for their lead product candidate SNS01-T. SNS01-T has been developed for the treatment of multiple myeloma, an incurable blood cancer that causes an accumulation of cancerous plasma cells (a type of B cell normally responsible for antibody production) in the bone marrow, which leads to destruction of the bone and interference with the normal production of immune system cells. The American Cancer Society estimated that in 2010 there will be approximately 20,180 new cases of multiple myeloma diagnosed and 10,650 multiple myeloma-related deaths in the United States.
Senesco’s SNS01-T technology is based on the discovery that the eIF5A gene has the ability to regulate apoptosis - as well as certain execution genes, pro-inflammatory cytokines (regulatory proteins), receptors and transcription factors - resulting in the ability to play a major role in the management of cell death and survival. eIF5A modulates apoptosis by controlling the signaling pathways responsible for triggering cell death. By acting as an arbitrageur between multiple pathways, the maximum benefit can be obtained, unlike competing technologies that act further "downstream" on individual targets.
Preclinical studies involving mice with melanoma tumors show that mice receiving treatment manipulating the eIF5A gene had a 92% reduction in tumor load as well as a statistically significant reduction in VEGF, a growth factor partially responsible for tumor growth. The median survival time in the mice receiving treatment was 25 days, or over three times that seen in the control mice and tumor regression, even remission, was also seen. A six week treatment with SNS01-T in mice with multiple myeloma tumors demonstrated 89% inhibition of tumor growth compared to the control group with 100% of the treated mice surviving for 73 days, while none of the control mice survived beyond 35 days. One third of the treated mice had reached remission and there was no sign of tumor growth up to 39 days after the end of treatment.
Recently Senesco had submitted its Investigational New Drug study application. The FDA had replied that the supplier needed to update its Drug Master File (DMF) before the multiple myeloma study could proceed. Consequently Senesco’s supplier submitted answers to FDA questions and an update to its DMF on May 12. The Company announced that the FDA has just responded, clearing the company to move forward with their clinical development program under the IND. This positive response from the FDA granting SNT an open IND should generate investor interest in the company. As an investment, it looks to be an exciting time for Senesco.
They have in the last 7 months received over $240,000 in funds from the US government under the Patient Protection and Affordable Care Act, in connection with Senesco’s development of treatment for multiple myeloma. They have been granted orphan drug status for SNS01-T and are currently looking to initiate a Phase Ib/2a study following their recent FDA go-ahead for their IND. Selling on the NYSE/AMEX with a market cap around $20 million, Senesco shares are trading at close to half of their 52 week high of $0.50.
Trading volume on Monday vs. Average was 408.67 % - so chances are there are going to be a lot of eyes on this stock. It will be interesting to see how investors react to the realization of the recent milestones in the pipeline.
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