To eliminate every malignant cell, an anticancer drug must overcome many formidable obstacles presented by a tumor mass.
The drug must travel through the tumor's intricate network of blood vessels and disperse through the vessel walls into the interstitum - an area inside the tumor that is rich in a tough connective tissue protein called collagen. From there, the drug must enter directly into cancer cells, which typically occupy less than 50% of the total volume of a tumor.
Unfortunately, the cancer cell has an abundance of defense mechanisms to block the full penetration of
chemotherapeutic agents.
What makes CHML exceptional is that its molecule is 33,000 times smaller than normal cells, enabling it to penetrate into the tumor mass. But more importantly, this facilitates its permeation directly into the cancer cell itself. Once it enters the cell, CHML is able to induce apoptosis (or "programmed cancer cell death").
CHML has been called a biological, "cancer seeking missile". CHML is a patented Biological composition consisting of: squalene, unsaturated & saturated fatty acids, and liposoluable vitamins. All components of CHML are extracted from natural sources and formulated using biological lipid-activated
technology.
Remarkable anti-cancer activity has been demonstrated both in vitro and in-vivo, and the compound was affirmed to be highly stable in extensive tests performed in multiple esteemed laboratories in both the U.S., and other in countries.
The following video demonstrates the destruction of cancer cells by CHML in real-time. The cancer type shown in the video is Sarcomas - 180 cells, with a concentration of 1 million cells per mL. These cells were added into a dish containing CHML at the concentration of 10 mg/mL. A sample of this mixture was immediately placed on a piece of glass and observed under a microscope. In just 1 minute and 43 seconds, cancer cells were destroyed by CHML.
1. Programmed Cancer Cell Death – Cancer Apoptosis
2.Anti-Cancer Angiogensis
3.Enhanced Immune Functions
According to reports of clinical trials at Phase II and Phase III, CHML does not cause hair loss, vomiting, diarrhea, mucosistis, leukopenia, thrombocytopenia, and anemia.
According to the reports of clinical trials at Phase II and Phase III, CHML has shown to cause tumor cell to shrink or disappear, using CT, MRI, or Ultrasonic examination.
Apoptosis is the process of programmed cell death (PCD) that may occur in multicellular organisms. Biochemical events lead to characteristic cell changes (morphology) and death. These changes include blebbing, cell shrinkage, nuclear fragmentation, chromatin condensation, and chromosomal DNA fragmentation. Cancer Apoptosis means it will target cancer cells and not normal cells, and consequently, induces cancer cells death.
Angiogenesis is the physiological process through which new blood vessels form from pre-existing vessels. This is distinct from vasculogenesis, which is the de novo formation of endothelial cells from mesoderm cell precursors. The first vessels in the developing embryo form through vasculogenesis, after which angiogenesis is responsible for most, if not all, blood vessel growth during development and in disease. Cancer Angiogenesis means cancer cells need more blood vessels and blood supply for their malignant growth. Anti-Cancer Angiogenesis means the cutting off of blood vessels and blood supply to cancer cells only and not to normal cells, and therefore, induces cancer cell deaths from starvation.
Because of cancer apoptosis, a large number of cancer antigens is spread thus causing the immune system to respond; also because of cancer apoptosis and anti-cancer angiogenesis, a great amount of nutrition goes into the normal cells of the immune system and causes the immune system to increase. The cells, antibodies, and organs of the immune system work to protect and defend the body against not only tumor cells but also bacteria or viruses.
Cell death was once thought to be a passive non-specific event, but is now known to be an active
biochemical process. Scientists have discovered that any cells have the ability to die by this process, called programmed cell death or apoptosis.
A number of important human diseases are caused by abnormal apoptosis control mechanisms, which can result in either a pathological increase in the number of cells (e.g. cancer) or a damaging loss of cells (e.g. degenerative diseases). Recent data has shown that cells have a discrete cell death pathway
defined by a specific set of genes. These genes encode proteins that form the biochemical process that ultimately invokes cell death.
The key genes that control the cell death process are the cell death effectors of the CED-3/ICE ("caspase") family and the cell death inhibitors of the Bcl-2 family. The caspase gene family encodes a set of proteases responsible for carrying out the death process. In a living cell, these proteases are normally
kept inactive by proteins encoded by the Bcl-2 family.
The caspases are a family of proteases responsible for carrying out the cell death process. In a living cell, these proteases are kept inactive by proteins on the mitochondrial cell surface from the BcL-2 family. When a cell is exposed to cell death signals such as ischemia, chemotherapy or radiation, BcL-2 function is blocked and caspase activators initiate the cell death cascade.
Small molecule drugs, like CHML, are able to specifically modulate the activity of the caspase family, the Bcl-2 family, or other key points in the apoptotic pathway, and exert control over the cell death process and have utility in diseases characterized by either excessive or insufficient levels of apoptosis.
CHML is able to specifically modulate key points in the apoptotic pathway.
p53 protein, commonly referred to as "the tumor suppressor gene," is a key player in the cellular apoptosis process. Bio-therapeutic activation of this pathway has been a popular target for recent drug
discovery technology.
p53, Bax and p21 protein levels were measured by immunoblotting assay, in MCF-7, ML-1, H1299 (human lung carcinoma) and RKO (human colon cancer,) cell lines after treatment with
CHML. p53 protein was found to be elevated in the MCF-7, RKO and ML-1 cells.
As the ability to induce apoptosis is not limited to p53 positive cell lines, it appears that CHML is able to provoke apoptosis through both p53-dependant and -independent pathways.
Angiogenesis - (the process of generating new capillary blood vessels) Is required for many physiological and pathological events including: healing, reproduction, embryonic development, and tumor growth, invasion and metastasis.
Under normal homeostatic conditions, regulation of angiogenesis is kept in check by a balance of several pro-angiogenic and anti-angiogenic factors. The process is also implicated in many disease conditions.
Malignant cells in microscopic tumors respond to local hypoxia by producing VEGF and initiating angiogenesis. Other angiogenic factors, like bFGF and Angiopoietin-2, are secreted by inflammatory cells that travel to these microscopic tumors.
VEGF, bFGF (basic fibroblast growth factor) and Angiopoietin-2 initiate the proliferation and migration of endothelial cells to form primitive tubes that become new blood vessels and feed tumor growth.
Anti-angiogenic agents like CHML work directly to inhibit the function of endothelial cells that are forming new blood vessels.
Specific receptors on these endothelial cells recognize the chemical signal of CHML to induce cell death.
The newly formed vasculature that carries nutrients to the tumor is then destroyed.
An absence of blood vessels and thus an absence of nutrients causes tumor cell death.
Supporting GLORY's drug discovery program, is a sophisticated new technology for drug administration. Arterial Infusion using DSA*, is a fast developing science performed by trained Interventional Radiologists.
Formerly used in the management of Cardiology related conditions, the technology is capable of delivering concentrated drugs to a highly specific site (e.g. tumor) via the arterial network.
DSA is capable of delivering concurrent imaging of the intricate vasculature of the tumoral network. This is used to guide the delivery of CHML, as well as measure the immediate effects on the tumors blood supply network. In recent studies, CHML was able to effect significant disruptions to the tumoral vasculature network in a number of various malignancies. In virtually every case, marked destruction of the tumor's feeding system could be observed in less than 30 minutes. This information further corroborates CHML's ability to penetrate a number of difficult tumors.
According to our clinical trial data for Phase II and Phase III, it was found that there was an average of 20-30% increase in the immune system after CHML treatment. What is the reason? The following may answer the question.
1. Because CHML induces cancer apoptosis, cancer antigen of the dead cancer cell is spread from the local cancer area to the whole body by blood circulation thus causing the immune system to strengthen.
1.1 Cancer antigen of the death cancer cell increase macrophage function of immune system.
1.2 Cancer antigen of the death cancer cell increase T cells function of immune system.
1.3 Cancer antigen of the death cancer cell increase T cells and B cells function of immune system.
2. Cancer cells eat a lot of nutrition from the entire body. When cancer cells die (meaning cancer apoptosis) and blood vessels cut off supplies to cancer cells (meaning anti-cancer angiogenesis), a great amount of nutrition goes into the immune system’s normal cells and causes immune system enhancement.
2.1 Cancer cells eat a lot of nutrition from the whole body.
2.2 A great amount of nutrition goes into normal immune cells and causes immune system to increase.
Glory has completed several phase I, II, and III clinical trials in several hundred human patients with highly encouraging results.
The most inspiring feature reported during the above trials is that CHML appears to be non-toxic to human bodies. Additionally, immune function actually increased an average of 20 - 30% after therapy.
With worldwide patents approved, CHML is currently under evaluation in the United States for cancer therapy. Although we highly anticipate CHML's approval, it is likely that this will require further testing, and unfortunately, more time.
Time is a luxury that may have significant limitations for terminally diagnosed Individuals. For these individuals, we have been granted the opportunity to provide CHML therapy at our modern, state-off-the-art facility, without delay.
To date, several hundred patients have been treated with CHML. Recent independent evaluations by leading scientists and organizations have called CHML one of the most exciting new anti-cancer agents available.
The majority of individuals receiving CHML treatment have been late stage patients. Usually, these patients have exhausted a broad range of conventional and/or alternative cancer treatments. Those with a history of significant conventional intervention are normally the most difficult to treat. However, even
in these cases, CHML has been successful.
Most importantly, CHML treatment has been accompanied by virtually none of the side effects commonly associated with cancer chemotherapy.
CHML may be administered by: IV drip, local injection, or by a sophisticated new technology which allows area-specific, concentrated drug delivery. Using DSA (Digital Subtraction Angiography), CHML is delivered directly to a site of major concern by Arterial Infusion.
At high concentrations, CHML was able to attain significant penetration into tumor networks and attain marked destruction of the tumor's feeding system in less than 30 minutes. Immediate, significant vessel
disruption was effected in a number of different malignant tumors.
Clinical studies demonstrate that patients receiving a lower rate of arterial infusion and IV drip, at 8 hours per day and 10-25 day per cycle, obtainined longer terms for cancer relapse.
Results of numerous DNA fragmentation assays, employing normal, as well as cancerous cells including: LL/2, K562, U937, YAC-1, SP2/0, RAJI, B5T and CRL-1739 have affirmed, that while DNA of all the cancer cells can be destroyed within 10 minutes by CHML, no fragmentation of normal cellular DNA occurs.
These studies have established that CHML possesses an exciting and novel characteristic, which the company refers to as: "SELECTIVE CANCER CELL APOPTOSIS." Based upon many studies and extensive research, it appears that - unlike many anti-cancer drugs commonly used in chemotherapy - CHML primarily effects and destroys ABNORMAL cells.
CHML has demonstrated the ability to cure a number of human mouse models, xenographically implanted with various forms of malignancy.
Glory has conducted clinical trials of its lead compound Cytotropic Heterogeneous Molecular Lipids (CHML), in human subjects diagnosed with a number of specific cancer conditions. Preliminary results have shown an unprecedented, durable response rate was attained. The most encouraging factor about these results is that CHML exhibited unparalleled efficacy, while there were virtually NO adverse reactions reported in any of the several hundred patients.*
Glory's objective is to be a leader in cancer therapy and to build an integrated pharmaceutical company focused on the oncology market.
To meet these objectives, the company intends to:
1. Pursue accelerated clinical development of Leverage the company's technology to fund clinical studies.
2. Commercialize products directly to focused physician groups.
3. Develop strategic collaborations for selected indications and markets.
The company's clinical trial strategy for its targeted indications is to identify subsets of larger patient populations in which clinical endpoints occur in high frequency and in a relatively short time frame. Glory plans to utilize data obtained in completed clinical trials for additional indications. The company believes that this strategy may allow it to reduce the size and duration of clinical trials, thereby generating statistically significant clinical results more quickly and cost effectively.
Cancer Indications - CHML has exhibited clinical efficacy against certain cancers, including liver, brain, colon and rectum, lung, breast, head and neck, stomach, skin, malignant lymphoma, leukemia, and metastasis cancers.
Experts estimate that in 2013 there were over 1.66 million individuals newly diagnosed with cancer in the United States. These included approximately 142,000 new cases of colon and rectum cancer, 30,000 new cases of liver & intrahepatic bile duct cancer, 23,000 new cases of brain & other nervous system tumor, 228,000 new cases of lung cancer, and 234,000 new cases of breast cancer.
An even more significant fact is - during this same year (2013) - over 580,000 American deaths were attributable to cancer. Glory maintains all intelectual property rights to CHML and its other compounds. The company plans to establish its own sales force, to first promote CHML for indications treated by a
relatively small, well defined groups of clinical specialists. To reach larger physician groups, such as gynecologists, the company may enter into marketing agreements with pharmaceutical or biotechnology companies.
Glory also plans to seek partners for international development and commercialization of its products in all indications.
*Negative incidents were limited to several minor (grade 1) episodes. No grade 2, 3 or 4 toxicities were experienced by any participants.
This is a clinical study to evaluate efficacy of Cytotroic Heterogenous Molecular Lipids (CHML), in patients with advanced or metastatic disease. Response to treatment, duration of response, and survival will be followed.
Patients are treated with 7 mg/kg of CHML, one time per day, 5 to 7 days per week by Intravenous drip (IV), Arterial infusion, local injection, or a combination of these methods.
The majority of patients presenting with irresettable hepatic disease have large tumors within a compromised liver. The main factors responsible for excluding an individual for this therapy are excessive portal vein obstruction and decompensated cirrhosis.
The best therapeutic results are obtained in hypervascular-encapsulated tumors (less than 5 cm diameter), with good underlying liver function. Some tumors are larger than 5 cm in diameter have responded well, but in general, histological studies have shown that complete tumors necrosis is far less
likely to occur with lesions larger than 5 cm.
Unencapsulated tumors and large tumors with capsular invasion derive some supply from the portal venous system, which has led to treatment failure with conventional chemoembolization. Based on this fact, segmental delivery may increase penetration of the agent into small peritumoral portal vein radicals.
CHML Treatment
A Study of CHML Treatments For Patients With
Advanced Hepatic Malignancies (Brief)
Glory Pharmaceuticals is a Biopharmaceutical Company focused on the development of a revolutionary medicine that prevents and treats cancer. It was found by Dr. Zheng Xu, in 1994. Since its inception, the professional medical team at Glory has continuously endeavored to improve cancer treatment using its innovative medicine and advanced technology.
The company's proprietary biological medicine -Cytotropic Heterogeneous Molecular Lipids was invented by Dr. Zheng Xu, with assistance from a group of scientists in various biological and medical fields. During the past 30+ years, numerous studies have been conducted with cellular, animal, pre-clinical and clinical trials. The advanced technology that was used to develop CHML is based upon the discovery of a biological compound, which has demonstrated the ability to induce selective apoptosis, or programmed cell death, in pre cancerous and cancerous cells. Laboratory experiments and clinical trials have shown effective results of CHML in destroying cancerous cells while exhibiting minimal toxicity to normal body cells.
CHML obtained its first patent in the United States in 1993. Thereafter, it has also acquired patents in Europe and Asia, in countries including Switzerland, France, Germany, Japan and the People's Republic of China. Currently, the company is in the final stage of obtaining production licensing in China. Glory is now focusing on the preparation of a United States Food & Drug Administration (FDA) drug registration application.
With the continuous effort to improve our medicine and treatment methodology, Glory believes that CHML has the potential to re-shape the palliative based treatment goals of today's oncologist, in a broad range of life-threatening malignant disorders.
Provide more effective, less toxic therapies, for the treatment and prevention of cancer.
The primary goal of the company is one that seeks to restore hope and health to individuals currently living with the label of - incurable. Our research has enabled us to personally witness these previously "incurable" cancers become dormant and extinct.
The reality of an acute need for new weapons in the war against cancer provides daily inspiration to operate with a sense of urgency. This perception is one that individuals affected by this disease, have come to depend on.
At Glory Pharmaceuticals, we continue the fight everyday - for every tomorrow!
The Board of Directors at Glory Pharmaceutical Company consists of leaders in the fields of medicine, business, finance, academic research and foreign affairs. Leveraging expertise from their respective industry, our directors pledge to bring the innovative technology of CHML to millions of cancer patients who continue to seek hope in their battles against cancer.
Zheng Xu, MD
Chief Executive Officer
Sean A. Cohen
Senior Vice President - Product Development Director
Jiawei Zhu, Ph.D
HEAD of the Biopharmaceutical Development Program,
SAIC Frederick, MD
Medical researcher at the National Cancer Institute - Cancer R&D Center, Frederick , MD
Qimin Zhan, Ph.D
Dept. Radiation Oncology, Pittsburhg Cancer Institute
University of Pittsburg School of Medicine
Shicheng Zhao, MD
Memorial Sloan-Kettering Cancer Center
New York, NY
Ping Z. Liang
United Law Firm
Washington DC
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Vienna, VA 22180
11500 Silvergate Dr.
Dublin, CA 94568
805 15St. NW, Suite 1101
Wasshinton DC 20005
Telephone: (703)204-1703
Fax: (703)204-1704
Email: corporate@glorypharma.com
ANTICANCER RESEARCH 19: 2893-2900 (1999)
Qimin Zhan and Zheng Xu
Abstract: In the present study, we have investigated the effect of cytotrpic heterogeneous molecular lipid (CHML), a new anticancer agent, on growth suppression in a variety of human tumor cell lines. At a non-toxic concentration (a range from 25 ug/ml to 100 ug/ml), CHML has shown to strongly inhibit tumor cell growth by using a typical colony survival assay. At a treatment of concentration of 50 ug/ml for 6 hours, CHML is ale to suppress 50% of the tumor cell colony formation. At a concentration of 100
ug/ml (the therapeutic dosage in the clinical trial), more than 90% of the cells were killed in human breast carcinoma MCF-7, colorectal carcinoma RKO, kidney carcinoma G410, lung carcinoma and human myeloid leukemia ML-1 lines.
Full Article
ANTICANCER RESEARCH 21:2477-2482 (2001)
Qimin Zhan, Shi-Cheng Zhao and Zheng Xu
Abstract: Cytotropic heterogeneous molecular lipid (CHML), which is a new anticancer agent with US patent number 5,260,067, has recently been shown to suppress tumor cell growth in multiple tumor lines and induce apoptosis in vitro (1). These results indicate that CHML may be an effective antitumor agent. In the present study, using both local injection and intravenous injection, we have investigated the suppressive effect of CHML on human breast cancer cells MCF-7 xenograft in nude mice.
Full Article
Anticancer Research. 2007 May-Jun;27(3B):1593-600
Chen XC, Yu B, Dong JC , Gu YX, Chen L, Wu QZ , Hou NP, Liu JX, Xu JT, Jin RX, Jin GQ, Yang XD , Cao YW, Tan JJ, Zhu B, Shen JC , Xu Z, Varticovski L, Wang XW
Abstract:
Hepatocellular carcinoma (HCC) and other forms of metastatic liver cancer (MLC) have poor outcomes due to the limited treatment options. Surgery, radiotherapy and chemotherapy have a limited success. Thus, there is an urgent need for novel therapies for patients with advanced HCC and MLC. The response and toxicity profile of a novel biological anticancer agent, cytotropic heterogeneous molecular lipids (CHML), in 135 Asian patients with hepatic malignancies treated at five different hospitals in China from April 1998 to August 2003 is described. This trial included 97 patients with HCC and 38 with MLC. The majority of these patients had received conventional therapies and many had failed to respond or relapsed. CHML was administered by intra-arterial ( i.a.) infusion with or without simultaneous intravenous (i.v.) infusion for 25 days with a rest of 2-4 weeks between each cycle. Fifty three percent of patients received two cycles, and 47% received three cycles. The complete response (CR) rates were 23% for HCC and 29% for MLC with an overall CR of 24%. The overall partial response (PR) was 53%. The patients with earlier stages and limited tumor burden had a better response, but a few patients with advanced disease also achieved PR. The patients who achieved CR or PR had a significant increase in long-term survival for up to five years. The treatment with CHML resulted in minimal toxicity and the reported adverse reactions were not higher than grade II. CHML is an effective therapy for hepatic malignancies, showing responses and increases in survival in patients in whom other therapies have failed. CHML is well tolerated and is an excellent candidate for Phase III clinical trials.
Full Article
Chin J Clin Neurosci 2001
China Oncology 2002
Fudan University 2003
Chin J Clin Neurosci 2003
Chin J Ultrasonogr 2004
Journal of Tongji University (Medical Science) 2014
