At least five major drug companies are advancing candidates, including Bristol-Myers Squibb, whose drug Yervoy is already approved for melanoma. Drug mechanisms that inhibit the PD-1 molecular pathway, which cancer cells hijack to evade destruction by the body's immune system, are a primary target in the emerging immunotherapy pipeline. The article also balanced the compelling promise of these candidates with the reality that PD-1 inhibitors and other immunotherapies face significant administration and cost hurdles. Much of the concern is associated with the challenge of stacking an immunotherapeutic drug on top of the toxicity of established therapies such as radiation, chemotherapy, targeted cancer agents or other PD-1 inhibitors. Beyond this challenge, the cost of combining such therapies could prove to be prohibitive considering that Yervoy alone costs $120,000 for four doses administered over 12 weeks.
From an Aethlon Medical perspective, the Wall Street Journal article serves to reinforce our vision that a medical device can deliver immunotherapeutic benefit to both established and candidate cancer therapies, and do so economically and without added drug toxicity.
Our device strategy targets a survival mechanism deployed by tumors to evade and defeat the immune system of cancer patients. This mechanism, which is not addressed by drug therapies, is the seretion of exosomes by cancerous tumors. Researchers have discovered that tumors release these particles to trigger the death of cancer fighting immune cells and facilitate the spread of metastasis. Additionally, the systemic elimination of exosomes may represent a novel strategy to inhibit the PD-1 molecular pathway. To date, researchers have demonstrated that the Aethlon Hemopurifier® can capture exosomes underlying lymphoma, melanoma, ovarian, and breast cancer. If you are not familiar with the Hemopurifier®, it is a first-in-class medical device that targets the rapid elimination of life-threatening infectious viruses and tumor-secreted exosomes from circulation.
Based on the recent approval (after 5+ years of effort) of an investigational device exemption (IDE) by FDA, we are preparing to initiate the first U.S. studies of Hemopurifier® therapy in Hepatitis-C (HCV) infected individuals. In studies previously conducted overseas, Hemopurifier® therapy was demonstrated to accelerate viral load depletion in hardest-to-treat HCV patients receiving standard-of-care drug therapy.
As a result of crossing the IDE approval threshold, we opened the door to advance relationships with medical institutes that have clinical interest in expanding Hemopurifier® indications to include various forms of cancer.
When we initiated our first cancer research activities, we were making two intuitive yet forward-looking bets. The first was that exosomes would emerge to become a vital therapeutic target. The second was a belief that novel immunotherapies would rethink the landscape for treating cancer. Today, tumor-secreted exosomes are well-documented therapeutic targets and cancer immunotherapies are expected to take center stage in the cancer treatment arena. There is growing hope that the marriage of traditional cancer therapies with next-generation immunotherapies may someday allow cancer to become a manageable condition much like HIV-infection is managed through a cocktail of treatment mechanisms. At Aethlon Medical, our role is to provide the oncology community with a therapeutic tool that counters the immunosuppressive impact of exosomes without adding drug toxicity to companion cancer therapies.
In closing, I am providing the scientific viewpoint of Dr. Douglas Taylor on the potential implications of Hemopurifier® therapy in cancer care. Dr. Taylor is credited with the discovery of tumor-secreted exosomes and is a leading published author on the topic. He is also one of the newest members of the Aethlon family as he has accepted the position of Chief Scientific Officer at our Exosome Sciences diagnostic subsidiary. The following is a statement from Dr. Taylor:
Evidence indicates that molecules, such as programmed cell death-1 (PD-1) and CTLA-4, are exploited by tumors to suppress patient immune surveillance, allowing the progression of cancers. These molecules and their ligands negatively regulate anti-tumor immune responses, particularly CD8+ effector T cells. Treatment of activated T cells with anti-PD-L1 antibodies reduce T cell proliferation, which correlates with attenuated IL-2 secretion. In vitro cytotoxicity studies and in vivo growth inhibition can be restored utilizing anti-PD-L1 antibodies or by genetic silencing of PD-1. The expression of PD-L1 on tumor cells inhibits anti-tumor immunity through engagement of PD-1 on effector T cells. Expression of PD-L1 on tumors is correlated with reduced survival in many tumor types.
Due to the role of these molecules in immune regulation and correlation with cancer outcomes, these pathways are being targeted for immunotherapy. Bristol Myers' experimental PD-1 inhibitor Nivolumab and Merck's candidate, MK-3475, block the PD-1/PD-L1 interaction, allowing the immune system to react with the tumor cells. Yervoy targets a similar checkpoint, inhibiting the CTLA-4 pathway. Unlike genetically targeted drugs, which disrupt mutations that fuel tumor growth, the new agents treat the immune system. Current interest in targeting these molecular pathways raises a concern that their normal function acts as to modulate the immune system to prevent attacks on healthy cells. Studies in murine models deficient for PD-1 developed dilated cardiomyopathy and congestive heart failure and that expression of PD-1 may also prevent autoimmune diseases. Based on the critical role of PD-1 and CTLA-4, targeting their expression may be problematic resulting in serious side effects on the host. However, an essential component of the activity of such molecules may be due to their presence on exosomes released by tumor cells. We previously demonstrated the presence of these immunoregulatory molecules on tumor-derived exosomes and their ability to suppress T cell activation and proliferation ( Taylor et al. Clinical Cancer Research , 9: 5113-5119, 2003). Thus, a reasonable approach that does not result in systemic toxicity would be the removal of these immunoregulatory molecules. Consequently, the ability of the Hemopurifier® to remove these circulating exosomes may provide a superior approach to treat these patients without the generalized inhibition of the respective molecular pathways. About Aethlon Medical
Aethlon Medical creates innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of devices the rapid, yet selective removal of disease promoting particles from the entire circulatory system. At present, The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer, and a medical device being developed under a 5-year contract with Defense Advanced Research Projects Agency (DARPA) to reduce the incidence of sepsis in combat-injured soldiers. For more information, please visit www.aethlonmedical.com.
Certain statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, that the company can successfully protect its intellectual property, that removal of exosomes from the human body will impact or lead to successful treatment of cancer, or that exosomes are the cause of tumor growth and progression, that the FDA will not approve the initiation of the Company's clinical programs or provide market clearance of the company's products, future human studies whether revenue or non-revenue generating of the Aethlon ADAPT™ system or the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer or hepatitis C therapies or as a standalone cancer or hepatitis C therapy, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
Marc Robins
877.276.2467
mr@aethlonmedical.com
Published at Investorideas.com newswire
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* Silver equivalency for the PEA includes silver, gold and copper
and excludes lead, zinc, molybdenum and tungsten values. Price ratio for
Ag: Au is (54.4:1), Ag:Cu is (7.3:1), both based on 5 year historic
metal price trends of US$22/oz silver, US$1200/oz gold, US$3/lbs.
copper. Metallurgical recovery is incorporated as recoverable metal.
Provisions for $8 million of working capital and $6 million in mine
closure have been made as part of the economic analyses in the PEA.
No smelter penalty charges for deleterious metals were applied to
the concentrate for the PEA. The study assumes that silver copper
concentrate will be shipped overseas by trucking from site to a port in
Mexico which is the most used route for concentrate producers in
operation near La Joya.
The bulk silver copper concentrates from preliminary results
produced from Manto and Structure composites show certain potentially
deleterious elements for smelting such as arsenic, antimony and bismuth.
Adding cyanide at cleaner flotation stages reduces the arsenic content
to acceptable market limits without sacrificing copper, silver and gold
recoveries. Additional test work is in progress to assess the
distribution, concentration and potential reduction of antimony and
bismuth.
* Silver equivalency for the resource estimation filed on March
27th, 2013 includes silver, gold and copper and excludes lead, zinc,
molybdenum and tungsten values. Ag:Au is 50:1, Ag:Cu is 86:1, based on 5
year historic metal price trends ofUS$24/oz silver, US$1200/oz gold,
US$3/lb copper. 100% metallurgical recovery is assumed. Classified by
EBA, a Tetra Tech Company and conforms to NI 43-101 and CIM definitions
for resources. All numbers are rounded. Inferred Resources have been
estimated from geological evidence and limited sampling and must be
treated with a lower level of confidence than Measured and Indicated
Resources. Note that AgEQ calculation for resources is different than
PEA economic analysis based on change in metal prices. Mineralization
boundaries used in the interpretation of the geological model and
resource estimate are based on a cut-off grade of 15 g/t AgEq using the
metal price ratios described above.
* 41 Optimized pit shells have been generated by keeping the
parameters used for the Whittle optimization constant (Operating Costs,
Metallurgical Recoveries, Pit Slope Angles and Discount Factor) and by
varying the Revenue using a range of metal prices illustrated in the
table above.
The 5,000 tpd processing plant will be comprised of crushing,
milling and standard flotation facilities with production of a
silver-copper concentrate as well as a gold-silver leaching circuit for
re-treatment of tailings. The PEA adopted as a guideline a mitigation of
environmental and social impact by minimizing the footprint of all
proposed operational facilities in the region.
Higher grades mined and crushed (1.63 gpt Au and 83.2 gpt Ag) in Q3
should be reflected in Q4 ounces produced with a current leach cycle
lag time on the pad of 30 to 60 days based on increasing pad height.
Silver grades continue to increase and gold grades remain consistent
with depth. In Q3, the internal cutoff grade for open pit ore was
maintained at 0.49 g/t AuEQ (metal spot prices and applicable
metallurgical recoveries) to reflect current metal prices. A total of
11,620 tonnes of underground ore were crushed in Q3 at an average grade
of 0.87 g/t Au and 123 g/t Ag.