Post by Hot Christian Stocks on Dec 8, 2013 21:46:04 GMT -5
Presenting
Nuvilex,
OTCQB: (NVLX)
Company Website
www.nuvilex.com/
listen to interview
www.nuvilex.com/11-content-slider/47-interviews
The live-cell encapsulation technology employed by Nuvilex is a way to enclose living cells in protective “cocoons” about the size of the head of a pin - we do not encapsulate drugs, but living cells. Each capsule can enclose approximately 10,000 cells; this number can differ depending upon the size of the cells encapsulated. The cell encapsulation technology used by Nuvilex can be classified as a “platform” upon which treatments for different indications may be built.
Depending on the type of cells used, the encapsulated cells can be employed in developing treatments for serious, debilitating and even deadly diseases. Nuvilex’s primary interests in the use of the live-cell encapsulation technology are for the development of treatments for various cancers and for diabetes.
Our live-cell encapsulation differs from that done by others in that the capsules that enclose the cells are made primarily of cellulose whereas others use substances such as alginate (a seaweed derivative), agarose, or chitosan, to name three. Because of this, the capsules are very robust and can withstand various external forces and this allows them to be implanted using needles or catheters without damage. Also, because they are made principally of cellulose, the capsules are essentially bio-inert in humans, so they do not degrade even after being present in the body for over two years.
LIVE-CELL ENCAPSULATION
The capsules contain pores that allow essential nutrients to enter and waste products and beneficial substances produced by the encapsulated cells to leave. Therefore, the cells inside the capsules can live and function for long periods of time after implantation. However, the pores are not large enough to permit the cells to leave the capsules or large enough to allow any cells of the body’s immune system to enter the capsules and destroy the encapsulated cells.
Even after more than two years in the body, no immune or inflammatory response is caused by the capsules themselves or by the cells within the capsules. In addition, the presence of the capsules does not cause fibrous overgrowth from, or other damage to, tissues nearby or surrounding the capsules.
Cells encapsulated using our technology can be stored frozen at -80°C or lower for long periods of time and then successfully thawed for use; this also allows for shipment of encapsulated cells to distant locations. Large-scale manufacturing of encapsulated cells using our technology has already been carried out according to GMP (Good Manufacturing Practice) conditions – a necessity for ultimately attaining marketing approval from drug regulatory authorities such as the U.S. FDA and the EMEA in Europe.
Nuvilex has recently acquired worldwide exclusive rights to the live cell-encapsulation technology described above from SG Austria Pte. Ltd. for the development of treatments for any and all types of cancer. The rights to use the cancer drug-activating cells (22P1G cells) that will be part of Nuvilex’s treatment for advanced pancreatic cancer (see Pancreatic Cancer section of this website) were also acquired. The acquisition of rights to use this live-cell encapsulation technology for the development of treatments for insulin-dependent diabetes is being finalized.
Pancreatic Cancer
According to the American cancer Society, in the US alone, approximately 45,000 new cases of pancreatic cancer are expected to be diagnosed this year and about 38,000 people are predicted to die from the disease; it is the leading cause of cancer deaths in the US and worldwide. Often pancreatic cancer is not diagnosed until it has reached an advanced stage. By this time, the cancer cannot be removed surgically, is often resistant to radiation therapy or chemotherapy, and has spread (metastasized) to other organs in the body. Because of this, the average survival of patients with advanced, inoperable pancreatic cancer is given in terms of weeks or months, not years.
To date, there has only been one anticancer drug approved (in 1997) for use by the US FDA as a single agent for the treatment of advanced pancreatic cancer, namely GEMZAR®, also known as gemcitabine. Since 2000, more than 30 pivotal (for drug marketing approval) late-phase clinical trials have been carried out in an attempt to improve upon the effectiveness of gemcitabine against advanced pancreatic cancer by adding other drugs to it. Only a very few of these trials have even been moderately successful.
One of the success stories was the combination of gemcitabine with TARCEVA® (erlotinib). In the Phase III pivotal trial of that combination, the one-year survival rate for the gemcitabine/TARCEVA® combination was 24% as compared to 17% for a gemcitabine/placebo combination. In 2005, the FDA approved the gemcitabine/TARCEVA® combination as first-line therapy for advanced, metastatic pancreatic cancer.
Results obtained in the clinical trial were compared with historical data for gemcitabine and included:
median survival time of 44 weeks (after diagnosis) with the cell encapsulation/ifosfamide treatment as compared to 28 weeks with gemcitabine;
doubling of the one-year survival rate – 36% with our treatment vs. 18% with gemcitabine;
tumor volume was reduced 25-50% in 4 of the 14 treated patients and remained stable in the remaining patients;
no serious drug-related side effects with the encapsulated cell/ifosfamide treatment whereas serious and very serious side effects were reported with gemcitabine; the lack of serious side effects using our treatment is probably related to the use of “lower than normal” doses of ifosfamide;
limited side effects and reduced cancer pain intensity led to a generally increased ‘quality of life” for the majority of patients.
In a “worst case” scenario, some clinical benefit was seen in 50% of patients and in a “best case” scenario, this number increased to 71%; none of the patients who experienced a clinical benefit required and increase in their pain medication. In addition, no deleterious effects were seen that could be attributed to the presence of the capsules or the encapsulated cells; this observation testifies to the ability of the capsules to protect the cells inside them from attack and rejection by the body’s immune system for significant periods of time.
Diabetes
The International Diabetes Federation estimates that more than 370 million people worldwide have diabetes and that about 190 million remain undiagnosed. Therefore, many millions of people are subject to the debilitating, and even deadly, complications of this disease;DIABETES 1 these include heart disease, vision loss, kidney disease, and nerve damage, particularly to the feet and legs, which may ultimately necessitate amputation. The worldwide market for diabetes treatments has been projected to reach $65 billion by 2020.
Diabetes is characterized by sustained high levels of sugar (glucose) in the blood. Glucose is a source of energy for all cells in the body. Normally, the levels of glucose are regulated by insulin produced by β-cells of the Islets of Langerhans (islet cells or islets)within the pancreas.
There are two “types” of diabetes:
Type 1 Diabetes - About 5-10% of diabetics have Type 1 disease,formerly called juvenile onset diabetes because it mainly occurs in those 20 of age or younger. Here, the pancreas, having been damaged by autoantibodies, is incapable of producing insulin. As a consequence, these individuals require insulin daily given either by injection or by an insulin “pump.”
Type 2 Diabetes - The majority of diabetics have Type 2 diabetes, also known as adult onset diabetes because it is not usually diagnosed until individuals are 35 years of age or older. In Type 2 diabetes, either the pancreas produces too little insulin or the insulin produced cannot be used efficiently by the body - a phenomenon known as “insulin resistance.” Insulin resistance develops because of many factors, including genetics, obesity, increasing age, and the presence of high blood sugar for a long time. Type 2 diabetes, at least in its early stages, can be “treated” by such things as increased exercise, weight loss, and by anti-diabetic drugs, but over time, many of these individuals may also require insulin administration either with or without anti-diabetic medications.
Friday, December 6, 2013
Nuvilex's Subsidiary, Medical Marijuana Sciences, Inc., Appoints Dr. Mark L. Rabe as Chairman of Its Scientific Advisory Board GlobeNewswire( (Fri, Dec 6)
Thursday, December 5, 2013
After Pancreatic Cancer, Eli Lilly and Nuvilex Could Battle Over Diabetes Treatment Marketwired( (Thu, Dec 5)
Wednesday, December 4, 2013
Record Diabetes Cases Highlight Need for Nuvilex Treatment Marketwired( (Wed, Dec 4)
Friday, November 29, 2013
Nuvilex Ahead of the Curve on Cannabidiol as FDA Issues Landmark Approval Marketwired( (Fri, Nov 29)
Monday, November 25, 2013
Nuvilex Accelerates Development of Treatments for Cancer and Diabetes With New Corporate Management Structure GlobeNewswire( (Mon, Nov 25)
Tuesday, November 19, 2013
Nuvilex's Acquisition of Diabetes Rights Should Put the Company on Everyone's RadarMarketwired( (Tue, Nov 19)
Wednesday, November 13, 2013
Nuvilex: The Triple Threat Marketwired( (Wed, Nov 13)
Tuesday, November 12, 2013
Investors Confidently Back Nuvilex's Acquisition of Diabetes Technology Marketwired( (Tue, Nov 12)
Friday, November 8, 2013
Nuvilex Advances Company Toward Future Clinical Treatments Through Successful Acquisition of Exclusive Worldwide Rights to Live-Cell Encapsulation Technology for DiabetesGlobeNewswire( (Fri, Nov 8)
Diabetes Treatment Drives Big Increase in Valuation Ahead for Nuvilex Marketwired( (Fri, Nov 8)
Thursday, November 7, 2013
Nuvilex Completes Acquisition of Exclusive Worldwide Rights to Live-Cell Encapsulation Technology for Diabetes GlobeNewswire( (Thu, Nov 7)
Wednesday, November 6, 2013
Unlike Other Biotechs, It Is Full Steam Ahead for NuvilexMarketwired( (Wed, Nov 6)
Tuesday, November 5, 2013
Nuvilex, Inc. Reaches Unofficial Starting Line of Its Phase 3 Pancreatic Cancer Clinical Trials Marketwired( (Tue, Nov 5)
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