Whether or not you've been keeping tabs, the American Society of Clinical Oncology's annual meeting is less than two weeks away. ASCO, as it's more commonly known, is arguably the single-most important event in the biotechnology and pharmaceutical sector each year.
You might be straining for a reason why a mention of ASCO would find its way into a discussion about high-cholesterol medications, but the release this week of the hundreds of study abstracts from this upcoming conference have potentially shed positive light on a class of LDL-lowering drugs known as statins.
Statins: the gold standard in high-cholesterol treatment
Those with high cholesterol who are at high risk of cardiovascular disease really have five options when it comes to cholesterol medications: statins, bile acid resins, fibrates, niacin, and cholesterol absorption inhibitors. Despite this handful of choices, statins are the most commonly prescribed medication in the world because of their superior results in trials compared with the remaining cholesterol-lowering choices with relatively few serious adverse events.
Top 5 Healthcare Technology Companies To Buy Right Now: Senesco Technologies Inc (SNTI)
Senesco Technologies, Inc., incorporated on September 30. 1999, is engaged in utilize its eukaryotic translation initiation Factor 5A, or Factor 5A, and deoxyhypusine synthase (DHS), and related technologies for human therapeutic applications to develop approaches to treat cancer and inflammatory diseases. In agricultural applications, the Company has licensed applications of the Factor 5A, DHS and Lipase platforms to develop the productivity of fruits, flowers, vegetables, agronomic and biofuel feedstock crops through the control of cell death and growth in plants.
Human Therapeutic Applications
The Company has developed a therapeutic candidate, SNS01-T, an improved formulation of SNS01, for the potential treatment of multiple myeloma and non-Hodgkin B-cell lymplomas. SNS01-T utilizes the Company's Factor 5A technology and consists of two components, which include a DNA plasmid (pDNA), expressing human eIF5A containing a lysine to arginine substitution at amino acid position 50, (eIF5AK50R), and a small inhibitory RNA (siRNA). These two components are combined in a fixed ratio with a polymer, polyethyleneimine (PEI), which enables self-assembly of the DNA and RNA into nanoparticles with demonstrated enhanced delivery to tissues and protection from degradation in the blood stream. The Company has also demonstrated that the combination of lenalidomide and SNS 01-T performs better than either treatment alone in mouses xenograft models of human mantle cell lymphoma. The Company's human therapeutic research program, which consists of pre-clinical in-vitro and in-vivo experiments designed to assess the role and mode of action of Factor 5A in human diseases and a phase 1a/2b clinical trial.
The Company competes with Celgene, Inc., Takeda/Millennium, ONYX Pharmaceuticals, Inc., Amgen Inc., Janssen Biotech, Inc., Novartis AG, and Pharmacyclics, Inc.
Agricultural Applications
The Company's agricultural research focuses on the discovery and develo! pment of certain gene technologies, which are designed to confer positive traits on fruits, flowers, vegetables, forestry species and agronomic crops. The Company's research and development initiatives for agriculture include develop and implement the DHS and Factor 5A gene technology in banana, canola, cotton, turfgrass, rice, alfalfa, corn, soybean and trees; and test the resultant crops for new beneficial traits such as increased yield, increased tolerance to environmental stress, disease resistance and more efficient use of fertilizer.
The Company competes with Mendel Biotechnology, Renessen LLC, Exelixis Plant Sciences, Inc., and Syngenta International AG.
Advisors' Opinion:- [By Peter Graham]
At the end of last week, small cap stocks Senesco Technologies, Inc (OTCBB: SNTI), VolitionRX Ltd (OTCMKTS: VNRX) and Micromem Technologies Inc (OTCBB: MMTIF) were all trending upwards ��ending up 13.65%, 8.73% and 7.61%, respectively, on Friday. However, it�� a new trading week with the last two trading days for the year. So what direction will these three small caps head in for the end of this year and into next year? Here is a quick look to help you decide on a trading or investment strategy:
- [By CRWE]
Today, SNTI has shed (-2.44%) down -0.0010 at $.0400 with�723,673 shares in play thus far (ref. google finance Delayed: 2:58PM EDT October 7, 2013).
Senesco Technologies, Inc. previously reported it has entered into a securities purchase agreement with certain investors to raise $1.725 million in gross proceeds through the sale of 69,000,000 shares of its common stock. The common stock was priced at $0.025 per share.
The offering is expected to close on or about October 2, 2013, subject to customary closing conditions. The net proceeds of the financing will be used primarily for working capital, research and development and general corporate purposes.
Top 10 Biotech Stocks To Own For 2014: CEL-SCI Corp (CVM)
CEL-SCI Corporation (CEL-SCI), incorporated on March 22, 1983, is engaged in the business of Multikine cancer therapy; New cold fill manufacturing service to the pharmaceutical industry, and ligand epitope antigen presentation System (LEAPS) technology, with two products, hemagglutinin type 1 and neuraminidase type 1 (H1N1) swine flu treatment for H1N1 hospitalized patients and CEL-2000, a rheumatoid arthritis treatment vaccine.
Multikine
CEL-SCI's Multikine, is being developed for the treatment of cancer. It is a cancer immunotherapy drugs called Combination Immunotherapy because it combines active and passive immunity in one product. It is the only cancer immunotherapy that both kills cancer cells and activates the general immune system to destroy the cancer. Multikine target the tumor micro-metastases for treatment failure. Multikine is also applicable in many other solid tumors.
New Manufacturing Facility
CEL-SCI's facility manufactures Multikine for CEL-SCI's Phase III clinical trial. CEL-SCI offers the use of the facility as a service to pharmaceutical companies and others, particularly those that need to fill and finish their drugs in a cold environment. Fill and finish is the process of filling injectable drugs in a sterile manner.
LEAPS
CEL-SCI's patented T-cell Modulation Process uses heteroconjugates to direct the body to choose a specific immune response. The heteroconjugate technology, referred to as LEAPS, is intended to stimulate the human immune system to fight bacterial, viral and parasitic infections, as well as autoimmune, allergies, transplantation rejection and cancer. Administered like vaccines, LEAPS combines T-cell binding ligands with small, disease associated and peptide antigens.
Using the LEAPS technology, CEL-SCI has created a peptide treatment for H1N1 (swine flu) hospitalized patients. This LEAPS flu treatment is designed to focus on the conserved, non-changing epitopes of the di! fferent strains of Type A Influenza viruses, including swine, avian or bird, and Spanish Influenza. CEL-SCI's LEAPS flu treatment contains epitopes.
Advisors' Opinion:- [By Bryan Murphy]
Names like Amgen, Inc. (NASDAQ:AMGN) and CEL-SCI Corporation (NYSEMKT:CVM) may have pioneered and even mainstreamed the idea of cancer immunology, but the nature of the branch of biotechnology means any company could send CEL-SCI or Amgen back-pedaling. See, it's not about size or deep pockets in the world of biotech anymore. It's about know-how and an idea, which can just as easily be discovered and developed by a small company as they can be a large company. That's why AMGN and CVM at least need to keep a close eye on budding immunology competitor TNI Biotech Inc. (OTCMKTS:TNIB).
- [By Bryan Murphy]
It may not have blazed a trail into the young, immunology segment of the biotech industry the way Dendreon Corporation (NASDAQ:DNDN) did back in 2010 with the debut of Provenge. It may not have the same immunology pipeline (and company size) that ImmunoGen, Inc. (NASDAQ:IMGN) boasts. One thing is pretty certain about cancer-immunotherapy developer CEL-SCI Corporation (NYSEMKT:CVM) right now, however - its stock may be poised to dole out a much bigger foreseeable-future reward than DNDN or IMGN are.
Top 10 Biotech Stocks To Own For 2014: Prosensa Holding NV (RNA)
Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company�� primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington�� disease. The Company�� clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company�� platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.
DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five, when boys begin to show signs of impaired motor development. PRO044, the Company�� product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.
Advisors' Opinion:- [By Sean Williams]
Shares of Sarepta climbed to a 52-week high of $55.61 in September shortly after an experimental rival drug, drisapersen, developed by Prosensa (NASDAQ: RNA ) and GlaxoSmithKline (NYSE: GSK ) , missed its primary end point by a mile in late-stage trials. However, Sarepta also tanked just weeks later after the Food and Drug Administration decided against supporting an accelerated drug approval for eteplirsen; the agency would not make the connection that increased dystrophin production led to its remarkable trial results.�Also, given the recent failure of drisapersen in a phase 3 study, the FDA felt it pertinent that Sarepta engage in a broader study. Shares ultimately dipped as low as $12.12.�
- [By Bryan Murphy]
Anybody who knows at least something about Prosensa Holding NV (NASDAQ:RNA) will at least know the stock turned into a disaster a few weeks ago, plunging from a close of $24.00 on September 19th to a close of $7.14 on September 20th, thanks to the failure of its MS drug drisapersen, which was jointly developed with GlaxoSmithKline plc (NYSE:GSK). Such is the life of a company with only one drug anywhere close to being approved; drisapersen was in Phase 3 trials - RNA shares could have just as easily gained 70% rather than lost 70% had the drug worked.
- [By John Udovich]
It should also be mentioned that earlier in the week, GlaxoSmithKline plc (NYSE: GSK) returned full rights of Duchenne muscular dystrophy drug drisapersen to their partner�Prosensa Holding NV (NASDAQ: RNA) and that news sent shares down 12.48% on�Monday. Moreover,�Prosensa Holding also sank some 70% last fall when Drisapersen failed a phase 3 trial by missing a primary endpoint measuring for how far patients could walk over the course of six minutes (the improvement�wasn't significantly better than the placebo).�However, Prosensa Holding also rose 24.37% yesterday after announcing�initial findings from further analyses from the aggregate data for drisapersen, with the CEO saying:
- [By Keith Speights]
An "alley-oop" from the opponent
Prosensa (NASDAQ: RNA ) shares made something of a slam dunk this week, jumping more than 16%. That dunk was made with what amounts to an "alley-oop" from its primary rival, Sarepta Therapeutics (NASDAQ: SRPT ) .
Top 10 Biotech Stocks To Own For 2014: Organovo Holdings Inc (ONVO)
Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.�� (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.
The Company has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.
The Company�� NovoGen MMX Bioprinter is an automate! d device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.
The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.
Advisors' Opinion:- [By Dan Caplinger]
The stock market fought its way back from early losses on Friday, with investors taking heart from positive economic data, even as they prepared for the beginning of a new earnings season in the next couple of weeks. At least for now, it appears that policy makers will do their utmost to prevent any huge disruption in the stock market, and that boded well for shareholders today. In particular, shares of Universal Display (NASDAQ: OLED ) , Taseko Mines (NYSEMKT: TGB ) , and Organovo Holdings (NYSEMKT: ONVO ) were among the best performers of the day, with their excitement helping to carry the whole market higher.
- [By MONEYMORNING]
During my July interview, Michael enthusiastically recommended 3D Systems Corp. (NYSE: DDD) and Organovo Holdings Inc. (NYSEMKT: ONVO). But he urged readers to take a wait-and-see approach with ExOne, saying the stock had just corrected.
Top 10 Biotech Stocks To Own For 2014: Provectus Pharmaceuticals Inc (PVCT)
Provectus Pharmaceuticals, Inc., incorporated on May 1, 1978, is a development-stage pharmaceutical company that is primarily engaged in developing ethical pharmaceuticals for oncology and dermatology indications. The Company develops and focuses to license or market and sells its two prescription drug candidates, PV-10 and PH-10. The Company has transferred all its intellectual property related to over the counter (OTC) products and non-core technologies to its subsidiaries and designated, such subsidiaries as non-core to its primary business of developing its oncology and dermatology prescription drug candidates. The Company focuses on developing its prescription drug candidates PV-10 and PH-10. The Company is developing PV-10 for treatment of several life threatening cancers, including metastatic melanoma, liver cancer, and breast cancer. The Company is developing PH-10 to provide minimally invasive treatment of chronic severe skin afflictions such as psoriasis and atopic dermatitis, a type of eczema. All of the Company's prescription drug candidates are in either the pre-clinical or clinical trial stage.
PV-10
As of December 31, 2011, the Company is developing PV-10, a sterile injectible form of rose bengal disodium (Rose Bengal), for direct injection into tumors. Its PV-10 is retained in diseased or damaged tissue but dissipates from healthy tissue. The Company had conducted Phase I and Phase IIstudies of PV-10 for the treatment of metastatic melanoma, and Phase I studies of PV-10 for the treatment of liver and breast cancers.
PH-10
The Company�� prescription drug candidate PH-10 is an aqueous hydrogel formulation of Rose Bengal for topical administration to the skin. The Company is developing PH-10 for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. In August 2011, the Company completed follow-up of all Phase IIc patients.
Over-the-Counter Pharmaceuticals
The Company had desi! gnated its subsidiary that holds its OTC products, GloveAid and Pure-ific, Pure-Stick, Pure N Clear as non-core. The Company�� GloveAid is a hand cream with both antiperspirant and antibacterial properties, for the comfort of users��hands during and after the wearing of disposable gloves. Its Pure-ific line of products includes two quick-drying sprays, Pure-ific and Pure-ific Kids, that immediately kill up to 99.9% of germs on skin and prevent regrowth for six hours. Pure-ific products prevent the spread of germs and thus complement its other OTC products designed to treat irritated skin or skin conditions, such as acne, eczema, dandruff and fungal infections. Its Pure-ific sprays have been designed with convenience in mind and are targeted towards mothers, travelers, and anyone concerned about the spread of sickness-causing germs.
The Company�� acne products Pure-Stick and Pure N Clear work by decreasing the production of fats, oils and sweat that create an environment conducive to unchecked growth of bacteria. Secondly, the products also act to reduce the number bacteria already present. The Pure-Stick and Pure N Clear are applied topically to affected areas there are no safety concerns with healthy skin.
Advisors' Opinion:- [By Jake L'Ecuyer]
Provectus Biopharmaceuticals (NYSE: PVCT) was also down, falling 3.02 percent to $3.01, letting out some air after the company's opening on the NYSE Friday.
- [By Luke Jacobi]
Provectus Biopharmaceuticals (NYSE: PVCT) was also down, falling 3.38 percent to $3.01, letting out some air after the company's opening on the NYSE Friday.
Top 10 Biotech Stocks To Own For 2014: Synageva BioPharma Corp (GEVA)
Synageva BioPharma Corp., incorporated in 1993, is a clinical-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of therapeutic products. It has several protein therapeutics in development, including two enzyme replacement therapies for lysosomal storage disorders and two programs for life-threatening genetic conditions. Its lead program, SBC-102, recombinant human lysosomal acid lipase (LAL), is its advanced pipeline program in clinical development for LAL Deficiency. This enzyme is responsible for the metabolism of cholesteryl esters and triglycerides that are delivered to lysosomes by a variety of routes, including low-density lipoprotein receptor mediated endocytosis. On November 2, 2012, Trimeris, Inc. merged with Synageva BioPharma Corp.
SBC-102 is produced by recombinant deoxyribonucleic acid (DNA) technology in egg white using its protein manufacturing platform. The Company has initiated natural history studies in approximately 20 countries. In addition to SBC-102, it is progressing protein therapeutic programs for other rare diseases, which are at different stages of preclinical development. These include two enzyme replacement therapies for other lysosomal storage disorders and two programs for other rare life-threatening conditions. As of December 31, 2011, its product candidate pipeline included SBC-102, SBC-103, SBC-104, SBC-105 and SBC-106.
SBC-104 is an extracellular protein that targets a severe, rare genetic condition. SBC-105 is an enzyme replacement therapy being developed to treat a severe, rare metabolic disorder. SBC-106 is a protein therapy that targets a severe and rare genetic condition.
Advisors' Opinion:- [By Garrett Cook]
Shares of Synageva BioPharma (NASDAQ: GEVA) were down 14.42 percent to $89.69 after the company reported that Phase 3 study met primary endpoint and six secondary endpoints across multiple disease-related abnormalities. Citigroup initiated coverage on Synageva BioPharma with a Neutral rating.
- [By Ben Levisohn]
Somaiya and team named Gilead and�Neurocrine Biosciences (NBIX) their top picks, hile putting Buy ratings on Celgene, Biogen Idec, Alexion (ALXN), Incyte (INCY), Pharmacyclics (PCYC) and Synageva (GEVA). BioMarin (BMRN), Infinity Pharmaceuticals (INFI) and Amgen (AMGN) earned Neutral ratings.
Top 10 Biotech Stocks To Own For 2014: Enanta Pharmaceuticals Inc (ENTA)
Enanta Pharmaceuticals, Inc., incorporated on July 25, 1995, is a research and development-focused biotechnology company. The Company uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. The Company is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes-protease (partnered with AbbVie, the former research-based pharmaceutical business of Abbott Laboratories), NS5A (partnered with Novartis) and nucleotide polymerase, as well as a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. ABT-450, discovered through its collaboration with AbbVie, is a protease inhibitor that has demonstrated in vitro potency against known resistant HCV mutants.
In Phase I studies, ABT-450 co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors, was shown to be safe and well tolerated. Co-administration of ABT-450 with ritonavir, which it refers to together as ABT-450/r, has enabled once-daily dosing of ABT-450. Phase II studies have demonstrated the efficacy of ABT-450/r in patients with chronic HCV, and other interferon-free Phase II studies of ABT-450-containing regimens continue. AbbVie is developing a next-generation protease inhibitor discovered within the Enanta-AbbVie collaboration. EDP-239 is the NS5A inhibitor discovered by the Company. The Company also has a program to develop nucleotide inhibitors to HCV NS5B polymerase, which is another DAA mechanism considered to have a barrier to resistance. The Company�� Bicyclolide antibiotic product candidate is EDP-788, which it is developing for use as an intravenous drug in the hospital setting and for oral dosing in the home setting. EDP-788 is a prodrug, which means that it is inactive until it is converted in the body into an active compound. EDP-788 is! a water-soluble molecule which, when administered in preclinical models, is cleanly and rapidly converted into the active compound.
Advisors' Opinion:- [By George Budwell]
Normally, such strong efficacy results would be hailed as a major achievement. However, these results are actually less impressive than those by competing drug's developed by AbbVie (NYSE: ABBV ) , Enanta Pharmaceuticals (NASDAQ: ENTA ) and Gilead. Bristol-Myers' therapy also has a treatment duration double that of Gilead's drug Sovaldi for genotype 1 patients. So, while these results are impressive in their own right, the therapy's commercial prospects may be limited due to the presence of superior competitors in the market.�
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