Saturday, March 17, 2012

Am I Part of the Cure?

Apoptosis: Programmed cell death
Am I Part of the Cure?
Senesco Technologies: A Unique Approach to Treating Disease
"Senesco Technologies Inc. (AMEX: SNT) is a development-stage biotechnology company with a proprietary technology that regulates programmed cell death (apoptosis), working in the areas of oncology and rheumatology alongside larger competitors like Dendreon Corporation (NASDAQ: DNDN), Merck & Co., Inc. (NYSE: MRK) and many others.

Initially, the company’s unique technology was developed for agricultural applications to enhance the quality, productivity and stress resistance of fruits, flowers, vegetables and other crops. The firm has licensed these technologies to several parties and continues to receive milestone payments, but it has shifted its focus to human therapeutic applications.

The company’s eIF5A gene regulatory technology could have broad applicability in human therapeutics by either inducing or inhibiting programmed cell death (apoptosis). Inducing apoptosis is useful in treating cancer where defective cancer cells don’t respond to normal apoptotic signals, while inhibiting apoptosis can be useful in modulating immune responses.

Senesco Targets Cancer with SNS01
Senesco’s primary focus is on the treatment of multiple myeloma – or cancer of the plasma cells in bone marrow. In animal studies, the company’s technology showed a 91% reduction in tumor volume and a decrease in tumor weight at high doses, while the survival rate was approximately 80% among those treated at the same dosage.

After filing for an IND with the FDA, the company initiated a Phase 1b/2a clinical study at the Mayo Clinic and has begun treating patients. Patients in each cohort will receive twice-weekly dosing for six weeks followed by a safety data review period before escalating to higher doses in subsequent cohorts.

Finally, the company has also been investigating the use of the same treatment for other B cell cancers, such as diffuse large B-cell lymphoma. Preliminary animal studies for these indications have shown an average 148% increase in median survival compared to treatment with control nanoparticles versus its SNS01-T treatment.

A Unique Business Model
Senesco’s promising clinical results to date are only dwarfed by its unique business model that could unlock significant value for shareholders. With the ability to target many different cancers and other diseases, promising clinical data from its existing studies could lead to partnerships to target other indications, and ultimately generate tremendous long-term value.

But even on its own, the company’s near-term income from its agricultural developments should help finance its human therapeutic indications and manage shareholder dilution. And with a recent capital raise under its belt, the company’s balance sheet is favorable for investors looking to get involved with the stock in the near-term."

 Chairman of Senesco Technolgies Dr. Harlan Waksal (co-founder of ImClone Systems -acquired by Eli Lilly NYSE: LLY)

Senesco Adds Second Clinical Site to Evaluate SNS01-T in Multiple Myeloma

"Senesco Technologies, Inc. (NYSE AMEX:SNT) announced that it has received Institutional Review Board approval and has finalized a clinical trial research agreement with the University of Arkansas for Medical Sciences ("UAMS") in Little Rock, Arkansas to evaluate SNS01-T, the Company's lead therapeutic candidate for the treatment of multiple myeloma in the on-going Phase 1b/2a study. 

"We are very pleased to have added UAMS as a clinical site along with the Mayo Clinic in order to accelerate patient enrollment and increase awareness of the SNS01-T study," stated Leslie J. Browne, Ph.D, President and Chief Executive Officer of Senesco. "We believe that the addition of UAMS will help accomplish both of these objectives by broadening access to the trial." 

In the study, patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of three patients will receive 0.0125 mg/kg by intravenous infusion. At the end of their 6 weeks of dosing, safety data for the group will be reviewed before the subsequent group receives a higher dosage. The escalated doses administered to the second to fourth groups will be 0.05, 0.2 and 0.375 mg/kg, respectively. The study is an open-label, multiple-dose, dose-escalation study, which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to a total of approximately 15 relapsed or refractory multiple myeloma patients. While the primary objective of this study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response and time to relapse or progression will be assessed using multiple well-established metrics including measurement of the monoclonal protein (M-protein). Patient dosing in the study was initiated in November, 2011 at the Mayo Clinic in Rochester, Minnesota."
Senesco Adds Additional Clinical Site to Evaluate SNS01-T in Multiple Myeloma
"Senesco Technologies, Inc.(NYSE AMEX:SNT) announced that it has received Institutional Review Board approval and has finalized a clinical trial research agreement with the West Virginia University Research Corporation of Morgantown, West Virginia to evaluate SNS01-T, the Company's lead therapeutic candidate, at the Mary Babb Randolph Cancer Center in the on-going Phase 1b/2a trial for the treatment of multiple myeloma. 

The Mary Babb Randolph Cancer Center (MBRCC) is West Virginia's premier cancer facility with a national reputation of excellence in cancer treatment, prevention and research. Located in Morgantown, within the Robert C. Byrd Health Sciences Center at West Virginia University School of Medicine, MBRCC is recognized by the American College of Surgeons Commission on Cancer for providing the best in cancer care. A multidisciplinary team of physicians, researchers and other healthcare experts work together to develop and implement the best possible individualized treatment plans, which include standard treatments and exciting alternatives offered through clinical trials. The principal investigator in the study at West Virginia University is Dr. Mehdi Hamadani. 

"With the addition of MBRCC, we now have a total of three excellent clinical sites involved in recruiting patients into the multiple myeloma study with SNS01-T," stated Leslie J. Browne, Ph.D, President and Chief Executive Officer of Senesco. "We expect that the additional broadening of patient access to SNS01-T achieved in the last week should significantly speed up completion of the study." 
Johnston-Sequoia Commentary:

"Am I part of the cure, or am I part of the disease?"
--- Christopher A. Martin (Coldplay - Clocks 1:58)

Cancer is a disease that is ubiquitous in our society, conversations and often our thoughts.  In fact - it is (unfortunately) the disease that indirectly led this writer to be typing on his computer this Saturday AM in South Surrey, British Columbia.  Our family was faced with this disease in 2005 and is the reason this Maritimer now lives on the West Coast.  Watching the people you love go through this terrible illness leaves one feeling helpless.  Needless to say this is where our intrinsic interest is rooted in assisting companies like Senesco Technologies.

As many of our readers know the four major components that we consider as mandatory for an emerging company (as we're perpetual students of Discovery Investing) are;
  • Strong Management;
  • Strong Balance Sheet;
  • 100% Ownership &
  • Potential World Class Discoveries

Management:

Dr. Harlan Waksal
Chairman
"Dr. Waksal has been the President and Sole Proprietor of Waksal Consulting L.L.C., which provides strategic business and clinical development counsel to biotechnology companies. Dr. Waksal co-founded the biotechnology company ImClone Systems Inc. in 1984. From March 1987 through July 2003, Dr. Waksal had served in various senior roles for ImClone Systems Inc. as follows: March 1987 through April 1994 - President; April 1994 through May 2002 - Executive Vice President and Chief Operating Officer; May 2002 through July 2003 - President, Chief Executive Officer and Chief Operating Officer. Dr. Waksal also served as a director of ImClone Systems Inc. from March 1987 through January 2005. Dr. Waksal is currently a member of the Board of Trustees of Oberlin College. Dr. Waksal received a Bachelor of Arts in Biology from Oberlin College and an M.D. from Tufts University School of Medicine."

Dr. John Thompson  
Executive Vice President, Chief Scientific Officer and Director
"Dr. Thompson was appointed President and Chief Executive Officer of Senesco in January 1999, and he continued in that capacity until September 1999 when he was appointed Executive Vice President of Research and Development. In July 2004, Dr. Thompson became Executive Vice President and Chief Scientific Officer. Dr. Thompson is the inventor of the technology that we develop. Since July 2001, he has been the Associate Vice President, Research and, from July 1990 to June 2001, he was the Dean of Science at the University of Waterloo in Waterloo, Ontario, Canada. Dr. Thompson has a Ph.D. in Biology from the University of Alberta, Edmonton, and he is a Fellow of the Royal Society of Canada. Dr. Thompson is also the recipient of a Lady Davis Visiting Fellowship, the Sigma Xi Award for Excellence in Research, the CSPP Gold Medal and the Technion Visiting Fellowship."
--- Forbes.com

Dr. Leslie Browne
President & CEO
"Leslie J. Browne, Ph.D. was appointed our President and Chief Executive Officer in May 2010. Dr. Browne has over 30 years of experience in the pharmaceutical industry. Prior to joining Senesco he served (from April 2007 to January 2009) as an independent director of Genelabs Technologies, which was sold to GSK, and from September 2004 to May 2008 as President, CEO and Director of Pharmacopeia, a Nasdaq listed company, where he transformed the company from a discovery contract research organization to a clinical development stage biopharmaceutical company with multiple internal development programs. In 1979, Dr. Browne began his industrial career at Ciba-Geigy, now Novartis, where he invented fadrozole, for the treatment of breast cancer and was closely involved in the discoveries of Femara and Diovan, which became major products for Novartis. Dr. Browne received his Bachelor of Science degree in Chemistry in 1972 from the University of Strathclyde, Glasgow Scotland. He received his Ph.D. in Organic Chemistry in 1978 from the University of Michigan and his postdoctoral training as a National Institutes of Health Postdoctoral Fellow at Harvard University from January 1978 to April 1979."
--- Forbes.com

Christopher Forbes
Director
"Mr. Forbes has been Vice Chairman of Forbes, Inc., which publishes Forbes Magazine and Forbes.com. From 1981 to 1989, Mr. Forbes was Corporate Secretary at Forbes. Prior to 1981, he held the position of Vice President and Associate Publisher. Mr. Forbes has been a director of Forbes, Inc. since 1977. Mr. Forbes is the Chairman of the American Friends of the Louvre, and he also sits on the boards of The Friends of New Jersey State Museum, The New York Academy of Art, and the Prince Wales Foundation. He is also a member of the board of advisors of The Princeton University Art Museum. Mr. Forbes received a Bachelor of Arts degree in Art History from Princeton University in 1972. In 1986, he was awarded the honorary degree of Doctor of Humane Letters by New Hampshire College and in 2003 was appointed a Chevalier of the Legion of Honor by the French Government."
--- Forbes.com


Balance Sheet:

"Senesco Announces Additional $1.0 Million Equity Financing Follow-on to January 2012 Financing
March 2nd, 2012 Senesco Technologies, Inc. (AMEX: SNT) announced  that it has entered into a securities purchase agreement to raise an additional $1.0 million in gross proceeds through the sale of 3,846,154 shares of its common stock. The investor will also receive 50% warrant coverage at an exercise price of $0.286 per share. The common stock and 50% warrant coverage was priced at $0.26 per Unit.
The follow-on to the January 2012 offering is expected to close on or about March 6, 2012. The net proceeds of the financing will be used primarily for working capital, research and development and general corporate purposes."
--- March 2nd 2012 Senesco Technologies Press Release


100% Ownership & Potential World Class Discoveries:
“Eukaryotic Translation Initiation Factor 5A (eIF5A)

eIF5A is a translation factor that functions as an elongation factor in protein translation as well as a shuttle protein regulating mRNA transport. eIF5A has been implicated in the regulation of cell growth, apoptosis (cell death), and inflammation (Taylor et al, 2007; Jin et al, 2008; Sun et al, 2010) and is the only mammalian protein where the naturally occurring amino acid, hypusine, is known to occur. The eIF5A gene encodes a lysine containing eIF5A protein that regulates apoptosis. The lysine is converted by a post translational modification into hypusine. The resulting structurally similar hypusine eIF5A protein promotes cell growth and survival. The two proteins possess almost opposite properties and appear to function like a switch to promote either cell death or cell survival, which enables them to play a key role in cancer and inflammation.

The regulation of the eIF5A is the basis for the design of SNS01-T, our first product candidate.

Our preclinical studies have shown that modulation of unmodified eIF5A kills cancer cells through both the intrinsic (mitochondrial) and the extrinsic (cell death receptor) pathways via activation of MAPK/SAPK signaling pathways, up-regulation of p53, and activation of caspases. Our studies indicate that over-expression of unmodified eIF5A is non-toxic to normal cells”
--- Senesco Technologies:  Eukaryotic Translation Initiation Factor 5A (eIF5A)

Why now?

"The world’s 10 largest drugmakers by sales, which include Pfizer and Glaxo, all have U.S. patents that will expire in the next two years, according to data compiled by Bloomberg. Pfizer, which lost patent protection on its cholesterol pill Lipitor yesterday, faces expirations on at least five drugs in 2012."

Sales of Lipitor, the world’s top-selling medicine with $10.7 billion in revenue last year, may drop by 58 percent to $4.5 billion next year, according to analysts’ estimates compiled by Bloomberg. Some patents on Glaxo’s Advair asthma inhaler, its best-selling product that accounted for almost 20 percent of revenue, will begin expiring in 2013, the data show.
“Large pharma is facing unprecedented revenue loss as these multiple blockbuster drugs lose their exclusivity,” Bloomberg Industries’ Berens said in a telephone interview. “Historically, they haven’t been able to replace them through internal R&D, so they have to look externally.”
--- Joseph Ciolli and Rita Nazareth
Bloomberg Businessweek December 1, 2011 


We believe this eIF5A ("Factor 5A") may have application in many different types of cancer - including leukemia & lymphoma.  We're very honored to be a part of this (as substantial shareholders) potentially game changing Technology.


To all of our readers, Happy St. Patty's day - hope you all enjoy the festivities!  We are shareholders of Senseco Technologies - as always please do your own due diligence.

2 comments:

  1. Matt: a long term retail holder of SNT am I. Again--an all inclusive review from you that brought in an issue that I had not considered in regards to SNT. The Major Pharma's need to fill their half filled and leaky pipeline. That begs the question of initial success in these 3 trials (too date). Should they be successful... then one hopes the shares are in majority friendly hands.

    On the worry side (there is always a worry side), the time to administer (6 weeks) and observe (no time given) on the initial trial is way over market expectations. We are approaching April 1, and nothing stated re the initial trial efficacy and safety. The PR fillers of the $ 1 Million private placement and the 2 new trials is all well and good (very good in fact)... but Management has to do a much better job of explaining the process side of administering and observation.

    Overall I have accumulated enough for now. I will await the results of trial 1... and then act accordingly. Should the results meet market (and , of course) Management's expectations, then I will accumulate more on the way up from 30-60 cents.

    My experience with all junior R&D driven pharma's is its best to go on real progress... not just original science. I have burned on issues of drug developments for Congestive Heart Failure (a family issue in my gene pool) and cancer before by accumulating too much, too soon.

    Thxs for the great review.

    Tom

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