Post by stocksdivas on Feb 29, 2012 14:03:41 GMT -5
ONCS ~ OncoSec Medical Incorporated
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers and metastatic disease. OMS ElectroOncology therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec's core technology is based upon its proprietary use of an electroporation platform, the OncoSec Medical System (OMS), to dramatically enhance the delivery and uptake of a locally delivered DNA-based immuno-cytokine (OMS ElectroImmunotherapy) or chemotherapeutic agents (OMS ElectroChemotherapy). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy targeting lethal skin cancers. More information is available at www.oncosec.com Additional information may also be found at OncoSec's Facebook, Twitter, and LinkedIn sites.
OncoSec Medical Incorporated
4690 Executive Drive
Suite 250
San Diego, CA 92121
Phone: 855-662-6732
Fax: 858-430-3832
Website: www.oncosec.com
www.otcmarkets.com/stock/ONCS/quote
Management Team
Punit Dhillon
President & Chief Executive Officer
Punit Dhillon, is a co-founder, President and Chief Executive Officer of OncoSec Medical Incorporated. Mr. Dhillon was formerly Vice President of Finance and Operations at Inovio Pharmaceuticals, Inc. (formerly Inovio Biomedical Corporation) until March 2011. In his corporate finance role, Mr. Dhillon was pivotal to the company raising over $125 million through multiple financings and several licensing deals including early stage deals with Merck and Wyeth. Mr. Dhillon was responsible for implementation of Inovio's corporate strategy, including achievement of annual budgets and milestones. He was also instrumental to the successful in-licensing of key intellectual property and a number of corporate transactions, including the acquisition and consolidation of Inovio AS, a Norwegian DNA delivery company, and led the recent merger with VGX Pharmaceuticals, which solidified Inovio’s strong position in the DNA vaccine industry. Mr. Dhillon has played an effective role as head of operations: recently he successfully completed the integration of the VGX-Inovio merger including cost-cutting of over 30% through the synergy assessment of both companies, consolidation of four operating locations to two bi-coastal offices, corporate rebranding and management of existing shareholders from both companies.
Mr. Dhillon has been a consultant and board member for several TSX-V listed early stage life science companies which matured through advances in their development pipelines and subsequent M&A transactions. Most recently, Mr. Dhillon was involved in the completion of a trilateral merger between three Capital Pool Companies listed on the TSX-V, which completed a qualifying transaction in April 2010 with a company specializing in conservation and demand management accessories for the utilities industry.
Prior to joining Inovio, Mr. Dhillon worked for a corporate finance law firm as a law clerk. Previous to 2003, he worked with MDS Capital Corp. (now Lumira Capital Corp.) as an intern analyst. Mr. Dhillon is an active member in his community and co-founder of Inbalance Network Inc. an organization focused on promoting an active lifestyle and grass roots community involvement, including scholarships to support students pursuing post-secondary education. Mr. Dhillon has a Bachelor of Arts with honors in Political Science and a minor in Business Administration from Simon Fraser University.
Mr. Dhillon resides in San Diego, California with his wife and daughter, and enjoys being active by running, swimming and biking.
http://www.oncosec.com./leadership/
Clinical Trials
OMS-I100 – Phase II Metastatic Melanoma Clinical Trial
Approximately 70,000 new cases of melanoma will be diagnosed every year, and this number is increasing. Despite this cancer being the deadliest form of all skin cancers, there still remains few treatment options for patients with advance stage disease. Previous data from a Phase I study demonstrated that OMS ElectroImmunotherapy in melanoma patients is safe and well-tolerated. In addition, promising therapeutic outcomes were observed with 53% of patients with metastatic disease demonstrating an objective response with this therapy.
A Phase II safety and efficacy trial using OMS ElectroImmunotherapy to deliver DNA IL-12 in patients with late-stage metastatic melanoma (OMS-I100) is being conducted in collaboration with the University of California San Francisco. This open-label, multi-center Phase II trial will enroll approximately 25 patients with advance stage cutaneous, in-transit malignant melanoma.
Enrollment for this clinical trial is expected to initiate before the end of 2011.
OMS-I110 – Phase II Merkel Cell Carcinoma Clinical Trial
Merkel cell carcinoma is a rare, but deadly disease. With a mortality rate of 40%, treatment options for these patients remain scarce, and recurrence following standard therapy is high. Because 80% of Merkel cell carcinomas are caused by an associated viral infection (Merkel cell polyomavirus), it is believed that an efficient and targeted immunotherapy may be a potential therapeutic approach for this disease.
A Phase II safety and efficacy trial using OMS ElectroImmunotherapy to deliver DNA IL-12 in patients with local and metastatic Merkel cell carcinoma (OMS-I110) is being conducted in collaboration with the University of Washington. This open-label, multi-center Phase II trial will enroll approximately 15 patients with Merkel cell carcinoma.
Enrollment for this clinical trial is expected to initiate before the end of 2011. For further information about this trial, Click Here.
OMS-I120 – Phase II Cutaneous T-Cell Lymphoma Clinical Trial
Cutaneous t-cell lymphoma is a rare form of non-Hodgkin’s lymphoma that affects T-cells of the immune system, resulting in immune dysfunction. Though not life-threatening, there remains few treatment options for this disease with current therapies not demonstrating long-term benefits. Because this is a disease of the immune system, it is believed that immunotherapy has the potential to provide safe and long-term benefits for this disease.
A Phase II safety and efficacy trial using OMS ElectroImmunotherapy to deliver DNA IL-12 in patients with early and late stage cutaneous t-cell lymphoma (OMS-I120) is being conducted in collaboration with the University of California San Francisco. This open-label, multi-center Phase II trial will enroll approximately 27 patients with cutaneous T-cell lymphoma.
Enrollment for this clinical trial is expected to initiate before the end of 2011.
http://www.oncosec.com./clinical-trials.php
Background
Cancer
Two characteristic features define a cancer: unregulated (i.e. autonomous) cell growth and the capacity to invade tissues and metastasize to distant sites
Uncontrolled cell growth is a property of all tumors or growths, but such tumors can be benign or malignant. Benign tumors have unregulated cell growth that is localized to one place in the body and is not typically life-threatening. Malignant, or cancerous, tumors are aggressive, invasive and intrude upon and destroy both adjacent and distal (distant) tissues. If left unchecked they can be fatal.
Some forms of cancer are inherited and may be transmitted through maternal eggs or paternal sperm while other forms of cancer are acquired from environmental conditions and exposure to carcinogens. Cancer is a genetic disease wherein abnormal changes in the cells’ DNA (genetic mutations) lead to the cells’ dysfunctional growth. The genetic mutations result in errors in both DNA replication and repair. In normal cells, when DNA is damaged the cell either repairs the damage or induces its own cell death (apoptosis). In cancer cells, the damaged DNA is not repaired. Instead, the cell replicates and perpetuates the same damaged DNA. The most common genetic mutations involve the activation of pro-cancer genes or the inactivation of tumor suppressor genes. From either activation or inactivation of these genes, the cells in question proliferate uncontrollably and invade nearby tissues and spread to other parts of the body where they damage or destroy normal cells.
Although mutation and damage to DNA does occur on a somewhat periodic basis, the body’s immune system is usually able to detect and eliminate abnormally growing cells. However, if the cancerous tumors are able to evade the immune system’s detection or overwhelm its ability to respond adequately, the cancer cells prevail and proceed with their uncontrolled and unregulated growth. As the cancer cell growth continues and spreads they cause different signs and symptoms that generally depend on the type of cancer, its size, location and its effect on nearby tissues or organs. Cancer can also occur in organs deep within the body and initially not cause any signs or symptoms. With continued proliferation and spread of the cancerous cells, cell clusters or solid tumors are formed. If left untreated, the spreading of cancer cells from a local to a regional area and then throughout the body can cause serious illness. The invasion of other normal tissues can result in various signs or symptoms such as fatigue, non-healing sores and changes in mole characteristics, pain, weight loss, disfigurement, and can impact the function of vital organs. While each cancer type can spread to various areas of the body, malignant cells can typically be found to invade the liver, lungs or brain. Impairment or dysfunction of these critical organs will usually result in the patient’s death.
Provided a cancerous tumor can be detected before it has spread and removed at an early stage the prognosis for specific cancer types can be quite favorable. During the later stages of metastatic cancer, in which systemic treatments become the necessity, the removal of tumors via surgery may still be necessary in order to manage pain and preserve organ function. To date there have been three main therapeutic approaches to the removal and management of tumor growth and spreading (metastatic) cancers: surgery, radiation and chemotherapy.
Current Therapeutic Approaches
…The current primary treatment for localized and operable tumors or lesions is surgery…
Surgery is the current primary treatment for localized and operable tumors or lesions. In this regard surgery requires cutting away (resecting) the tumor mass and a surrounding margin of healthy tissue to ensure that no cancer cells remain at the tumor site. Surgery can potentially cause both physical disfigurement and/or debilitating effects on organ function. In addition surgery may require a costly and lengthy hospital stay.
Radiation therapy is sometimes used in conjunction with surgery to shrink a tumor before surgical removal, or afterwards to destroy any cancer cells that may remain. Unfortunately, the combination of surgery and radiation can be very damaging to nerves, blood vessels, or vital organs within the treatment zone. Radiation is also an expensive therapeutic approach, and requires considerable expertise to administer. Radiation brings with it significant complications, including nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the real potential for damage to normal tissue, including the formation of new cancerous lesions.
Chemotherapy is typically a secondary or palliative treatment to help control systemic tumor growth whereas both surgery and radiation may be considered local treatments. In response to the spread of cancer, physicians infuse chemotherapy agents to circulate throughout the body - system wide - and in high concentrations in order to counter the difficulty that some chemotherapeutic agents have in reaching and penetrating the cell membrane to bring about the intended cancer cell death. Unfortunately, this system-wide application often has serious side effects, killing healthy as well as cancerous cells. The systemic use of chemotherapeutics can produce alopecia (loss of hair); nausea; vomiting; myelosuppression (resulting in reduction in the number of platelets, red cells and white cells found in the circulation, and therefore less resistance to infection); and drug resistance. Unfortunately, chemotherapy is curative for only a few tumor types.
Emerging treatments, such as radio frequency (RF) ablation, cryoablation, photodynamic therapy, and percutaneous ethanol injection are all in limited clinical use. Generally, each of the above modalities has drawbacks that potentially limit their broad-based use for the treatment of solid tumors.
None of these therapies is able to selectively destroy cancer cells without having some impact on normal both local and distal tissues. Consequently there remains a significant unmet medical need for an approach that can effectively treat cancerous tumors while preserving healthy tissue and minimizing detrimental functional, cosmetic and other side effects.
OncoSec’s novel tumor therapies are designed to address the drawbacks of conventional therapies by being tissue sparing; providing potential functional, cosmetic and quality of life benefits; being less invasive and reducing side effects; and potentially reducing both treatment and post-treatment costs.
Market Opportunity
Cancer is the second largest cause of death in most developed nations. It is estimated that in the United States there will be 1.52 million new cancer cases diagnosed and 560,000 deaths. The incident rate of cancer in the European Union was 2.4 million while the mortality rate was 1.23 million. Despite advances in cancer research and approval of new therapies each year, the average five-year relative survival rate of patients with non-cutaneous cancers has only improved from 50% in 1974-76 to 66% in 1999-2006. In addition, conventional therapies continue to negatively impact the patient’s quality of life as surgery affects appearance and organ function, and radiation and chemotherapy cause significant side effects based on the non-selective cytotoxic effects on normal tissues. This is truly an area with notable unmet medical needs. In the United States the costs of cancer, including mortality, morbidity and direct medical costs, exceeded $228 billion in 2008: approximately $93 billion for direct medical costs (total of all health expenditures), at least $19 billion for indirect morbidity costs (cost of lost productivity due to illness), and over $116 billion for indirect mortality costs.
While there can be no single panacea for cancer treatment, there is a valuable opportunity for a minimally invasive treatment using new technology to enhance the effectiveness and safety of therapeutic drugs targeting cancer. To date no new treatment methods have produced these desired outcomes. Thus, there are significant opportunities to provide clinical benefits and diminish the detrimental cosmetic and functional impacts of surgery and radiation and the general side effects of chemotherapy. Furthermore, there is motivation by budget-constrained healthcare providers to embrace lower cost oncology solutions. Electrochemoporation therapy can deliver these benefits for many oncology indications, and has significant potential to be adopted initially as an adjuvant or secondary treatment, and ultimately as a new primary treatment method.
OncoSec Medical System’s applicability to different solid tumor cancers is technically defined by:
Organ/disease applicability: Tumors that are visible or under the skin are readily accessible using the OncoSec Medical System applicators. Internal organs may be accessible with current applicators as part of an intra-operative procedure (surgery for diagnostic or resection purposes), or may require a specialized applicator.
Tissue characteristics: Soft or hollow organs (e.g. lungs, intestine, and colon) are not well suited to the current OMS applicator.
Cancer stage: The therapeutic value of the OncoSec Medical System will be influenced by the ability to diagnose and treat certain cancers in early versus late stages. Electroporation therapy has the benefit of treating recurrences and regional advancement without tissue removal.
The OncoSec Medical System is highly effective in treating solid tumors, with the unique and important advantage of preserving surrounding healthy cells and tissue. The OncoSec Medical System therapy can be applied to a wider margin around a tumor, increasing the probability of killing outlying cancer cells that may reside in the margin but without a detrimental cosmetic or functional impact, making this therapy suitable for addressing a host of cancer types and locations. While the OncoSec Medical System is potentially applicable to all solid tumor types, we are initially targeting indications such as head & neck and cutaneous skin cancers where the OMS is particularly well suited for efficacy, safety and cost effectiveness.
The OncoSec Medical System is still in development but has already shown remarkable promise in numerous clinical trials in a variety of different solid tumor types. Evidence to date suggests that the OncoSec Medical System’s selective, localized application and its efficacy, safety, and low cost strongly position the solution to quickly become an important new treatment modality in oncology.
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers and metastatic disease. OMS ElectroOncology therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec's core technology is based upon its proprietary use of an electroporation platform, the OncoSec Medical System (OMS), to dramatically enhance the delivery and uptake of a locally delivered DNA-based immuno-cytokine (OMS ElectroImmunotherapy) or chemotherapeutic agents (OMS ElectroChemotherapy). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec's clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy targeting lethal skin cancers. More information is available at www.oncosec.com Additional information may also be found at OncoSec's Facebook, Twitter, and LinkedIn sites.
OncoSec Medical Incorporated
4690 Executive Drive
Suite 250
San Diego, CA 92121
Phone: 855-662-6732
Fax: 858-430-3832
Website: www.oncosec.com
www.otcmarkets.com/stock/ONCS/quote
Management Team
Punit Dhillon
President & Chief Executive Officer
Punit Dhillon, is a co-founder, President and Chief Executive Officer of OncoSec Medical Incorporated. Mr. Dhillon was formerly Vice President of Finance and Operations at Inovio Pharmaceuticals, Inc. (formerly Inovio Biomedical Corporation) until March 2011. In his corporate finance role, Mr. Dhillon was pivotal to the company raising over $125 million through multiple financings and several licensing deals including early stage deals with Merck and Wyeth. Mr. Dhillon was responsible for implementation of Inovio's corporate strategy, including achievement of annual budgets and milestones. He was also instrumental to the successful in-licensing of key intellectual property and a number of corporate transactions, including the acquisition and consolidation of Inovio AS, a Norwegian DNA delivery company, and led the recent merger with VGX Pharmaceuticals, which solidified Inovio’s strong position in the DNA vaccine industry. Mr. Dhillon has played an effective role as head of operations: recently he successfully completed the integration of the VGX-Inovio merger including cost-cutting of over 30% through the synergy assessment of both companies, consolidation of four operating locations to two bi-coastal offices, corporate rebranding and management of existing shareholders from both companies.
Mr. Dhillon has been a consultant and board member for several TSX-V listed early stage life science companies which matured through advances in their development pipelines and subsequent M&A transactions. Most recently, Mr. Dhillon was involved in the completion of a trilateral merger between three Capital Pool Companies listed on the TSX-V, which completed a qualifying transaction in April 2010 with a company specializing in conservation and demand management accessories for the utilities industry.
Prior to joining Inovio, Mr. Dhillon worked for a corporate finance law firm as a law clerk. Previous to 2003, he worked with MDS Capital Corp. (now Lumira Capital Corp.) as an intern analyst. Mr. Dhillon is an active member in his community and co-founder of Inbalance Network Inc. an organization focused on promoting an active lifestyle and grass roots community involvement, including scholarships to support students pursuing post-secondary education. Mr. Dhillon has a Bachelor of Arts with honors in Political Science and a minor in Business Administration from Simon Fraser University.
Mr. Dhillon resides in San Diego, California with his wife and daughter, and enjoys being active by running, swimming and biking.
http://www.oncosec.com./leadership/
Clinical Trials
OMS-I100 – Phase II Metastatic Melanoma Clinical Trial
Approximately 70,000 new cases of melanoma will be diagnosed every year, and this number is increasing. Despite this cancer being the deadliest form of all skin cancers, there still remains few treatment options for patients with advance stage disease. Previous data from a Phase I study demonstrated that OMS ElectroImmunotherapy in melanoma patients is safe and well-tolerated. In addition, promising therapeutic outcomes were observed with 53% of patients with metastatic disease demonstrating an objective response with this therapy.
A Phase II safety and efficacy trial using OMS ElectroImmunotherapy to deliver DNA IL-12 in patients with late-stage metastatic melanoma (OMS-I100) is being conducted in collaboration with the University of California San Francisco. This open-label, multi-center Phase II trial will enroll approximately 25 patients with advance stage cutaneous, in-transit malignant melanoma.
Enrollment for this clinical trial is expected to initiate before the end of 2011.
OMS-I110 – Phase II Merkel Cell Carcinoma Clinical Trial
Merkel cell carcinoma is a rare, but deadly disease. With a mortality rate of 40%, treatment options for these patients remain scarce, and recurrence following standard therapy is high. Because 80% of Merkel cell carcinomas are caused by an associated viral infection (Merkel cell polyomavirus), it is believed that an efficient and targeted immunotherapy may be a potential therapeutic approach for this disease.
A Phase II safety and efficacy trial using OMS ElectroImmunotherapy to deliver DNA IL-12 in patients with local and metastatic Merkel cell carcinoma (OMS-I110) is being conducted in collaboration with the University of Washington. This open-label, multi-center Phase II trial will enroll approximately 15 patients with Merkel cell carcinoma.
Enrollment for this clinical trial is expected to initiate before the end of 2011. For further information about this trial, Click Here.
OMS-I120 – Phase II Cutaneous T-Cell Lymphoma Clinical Trial
Cutaneous t-cell lymphoma is a rare form of non-Hodgkin’s lymphoma that affects T-cells of the immune system, resulting in immune dysfunction. Though not life-threatening, there remains few treatment options for this disease with current therapies not demonstrating long-term benefits. Because this is a disease of the immune system, it is believed that immunotherapy has the potential to provide safe and long-term benefits for this disease.
A Phase II safety and efficacy trial using OMS ElectroImmunotherapy to deliver DNA IL-12 in patients with early and late stage cutaneous t-cell lymphoma (OMS-I120) is being conducted in collaboration with the University of California San Francisco. This open-label, multi-center Phase II trial will enroll approximately 27 patients with cutaneous T-cell lymphoma.
Enrollment for this clinical trial is expected to initiate before the end of 2011.
http://www.oncosec.com./clinical-trials.php
Background
Cancer
Two characteristic features define a cancer: unregulated (i.e. autonomous) cell growth and the capacity to invade tissues and metastasize to distant sites
Uncontrolled cell growth is a property of all tumors or growths, but such tumors can be benign or malignant. Benign tumors have unregulated cell growth that is localized to one place in the body and is not typically life-threatening. Malignant, or cancerous, tumors are aggressive, invasive and intrude upon and destroy both adjacent and distal (distant) tissues. If left unchecked they can be fatal.
Some forms of cancer are inherited and may be transmitted through maternal eggs or paternal sperm while other forms of cancer are acquired from environmental conditions and exposure to carcinogens. Cancer is a genetic disease wherein abnormal changes in the cells’ DNA (genetic mutations) lead to the cells’ dysfunctional growth. The genetic mutations result in errors in both DNA replication and repair. In normal cells, when DNA is damaged the cell either repairs the damage or induces its own cell death (apoptosis). In cancer cells, the damaged DNA is not repaired. Instead, the cell replicates and perpetuates the same damaged DNA. The most common genetic mutations involve the activation of pro-cancer genes or the inactivation of tumor suppressor genes. From either activation or inactivation of these genes, the cells in question proliferate uncontrollably and invade nearby tissues and spread to other parts of the body where they damage or destroy normal cells.
Although mutation and damage to DNA does occur on a somewhat periodic basis, the body’s immune system is usually able to detect and eliminate abnormally growing cells. However, if the cancerous tumors are able to evade the immune system’s detection or overwhelm its ability to respond adequately, the cancer cells prevail and proceed with their uncontrolled and unregulated growth. As the cancer cell growth continues and spreads they cause different signs and symptoms that generally depend on the type of cancer, its size, location and its effect on nearby tissues or organs. Cancer can also occur in organs deep within the body and initially not cause any signs or symptoms. With continued proliferation and spread of the cancerous cells, cell clusters or solid tumors are formed. If left untreated, the spreading of cancer cells from a local to a regional area and then throughout the body can cause serious illness. The invasion of other normal tissues can result in various signs or symptoms such as fatigue, non-healing sores and changes in mole characteristics, pain, weight loss, disfigurement, and can impact the function of vital organs. While each cancer type can spread to various areas of the body, malignant cells can typically be found to invade the liver, lungs or brain. Impairment or dysfunction of these critical organs will usually result in the patient’s death.
Provided a cancerous tumor can be detected before it has spread and removed at an early stage the prognosis for specific cancer types can be quite favorable. During the later stages of metastatic cancer, in which systemic treatments become the necessity, the removal of tumors via surgery may still be necessary in order to manage pain and preserve organ function. To date there have been three main therapeutic approaches to the removal and management of tumor growth and spreading (metastatic) cancers: surgery, radiation and chemotherapy.
Current Therapeutic Approaches
…The current primary treatment for localized and operable tumors or lesions is surgery…
Surgery is the current primary treatment for localized and operable tumors or lesions. In this regard surgery requires cutting away (resecting) the tumor mass and a surrounding margin of healthy tissue to ensure that no cancer cells remain at the tumor site. Surgery can potentially cause both physical disfigurement and/or debilitating effects on organ function. In addition surgery may require a costly and lengthy hospital stay.
Radiation therapy is sometimes used in conjunction with surgery to shrink a tumor before surgical removal, or afterwards to destroy any cancer cells that may remain. Unfortunately, the combination of surgery and radiation can be very damaging to nerves, blood vessels, or vital organs within the treatment zone. Radiation is also an expensive therapeutic approach, and requires considerable expertise to administer. Radiation brings with it significant complications, including nausea, diarrhea, dry mouth, taste alterations, loss of appetite, and the real potential for damage to normal tissue, including the formation of new cancerous lesions.
Chemotherapy is typically a secondary or palliative treatment to help control systemic tumor growth whereas both surgery and radiation may be considered local treatments. In response to the spread of cancer, physicians infuse chemotherapy agents to circulate throughout the body - system wide - and in high concentrations in order to counter the difficulty that some chemotherapeutic agents have in reaching and penetrating the cell membrane to bring about the intended cancer cell death. Unfortunately, this system-wide application often has serious side effects, killing healthy as well as cancerous cells. The systemic use of chemotherapeutics can produce alopecia (loss of hair); nausea; vomiting; myelosuppression (resulting in reduction in the number of platelets, red cells and white cells found in the circulation, and therefore less resistance to infection); and drug resistance. Unfortunately, chemotherapy is curative for only a few tumor types.
Emerging treatments, such as radio frequency (RF) ablation, cryoablation, photodynamic therapy, and percutaneous ethanol injection are all in limited clinical use. Generally, each of the above modalities has drawbacks that potentially limit their broad-based use for the treatment of solid tumors.
None of these therapies is able to selectively destroy cancer cells without having some impact on normal both local and distal tissues. Consequently there remains a significant unmet medical need for an approach that can effectively treat cancerous tumors while preserving healthy tissue and minimizing detrimental functional, cosmetic and other side effects.
OncoSec’s novel tumor therapies are designed to address the drawbacks of conventional therapies by being tissue sparing; providing potential functional, cosmetic and quality of life benefits; being less invasive and reducing side effects; and potentially reducing both treatment and post-treatment costs.
Market Opportunity
Cancer is the second largest cause of death in most developed nations. It is estimated that in the United States there will be 1.52 million new cancer cases diagnosed and 560,000 deaths. The incident rate of cancer in the European Union was 2.4 million while the mortality rate was 1.23 million. Despite advances in cancer research and approval of new therapies each year, the average five-year relative survival rate of patients with non-cutaneous cancers has only improved from 50% in 1974-76 to 66% in 1999-2006. In addition, conventional therapies continue to negatively impact the patient’s quality of life as surgery affects appearance and organ function, and radiation and chemotherapy cause significant side effects based on the non-selective cytotoxic effects on normal tissues. This is truly an area with notable unmet medical needs. In the United States the costs of cancer, including mortality, morbidity and direct medical costs, exceeded $228 billion in 2008: approximately $93 billion for direct medical costs (total of all health expenditures), at least $19 billion for indirect morbidity costs (cost of lost productivity due to illness), and over $116 billion for indirect mortality costs.
While there can be no single panacea for cancer treatment, there is a valuable opportunity for a minimally invasive treatment using new technology to enhance the effectiveness and safety of therapeutic drugs targeting cancer. To date no new treatment methods have produced these desired outcomes. Thus, there are significant opportunities to provide clinical benefits and diminish the detrimental cosmetic and functional impacts of surgery and radiation and the general side effects of chemotherapy. Furthermore, there is motivation by budget-constrained healthcare providers to embrace lower cost oncology solutions. Electrochemoporation therapy can deliver these benefits for many oncology indications, and has significant potential to be adopted initially as an adjuvant or secondary treatment, and ultimately as a new primary treatment method.
OncoSec Medical System’s applicability to different solid tumor cancers is technically defined by:
Organ/disease applicability: Tumors that are visible or under the skin are readily accessible using the OncoSec Medical System applicators. Internal organs may be accessible with current applicators as part of an intra-operative procedure (surgery for diagnostic or resection purposes), or may require a specialized applicator.
Tissue characteristics: Soft or hollow organs (e.g. lungs, intestine, and colon) are not well suited to the current OMS applicator.
Cancer stage: The therapeutic value of the OncoSec Medical System will be influenced by the ability to diagnose and treat certain cancers in early versus late stages. Electroporation therapy has the benefit of treating recurrences and regional advancement without tissue removal.
The OncoSec Medical System is highly effective in treating solid tumors, with the unique and important advantage of preserving surrounding healthy cells and tissue. The OncoSec Medical System therapy can be applied to a wider margin around a tumor, increasing the probability of killing outlying cancer cells that may reside in the margin but without a detrimental cosmetic or functional impact, making this therapy suitable for addressing a host of cancer types and locations. While the OncoSec Medical System is potentially applicable to all solid tumor types, we are initially targeting indications such as head & neck and cutaneous skin cancers where the OMS is particularly well suited for efficacy, safety and cost effectiveness.
The OncoSec Medical System is still in development but has already shown remarkable promise in numerous clinical trials in a variety of different solid tumor types. Evidence to date suggests that the OncoSec Medical System’s selective, localized application and its efficacy, safety, and low cost strongly position the solution to quickly become an important new treatment modality in oncology.
