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PRODUCT INFORMATION
TBL-12 Clinical Trials - Multiple Myeloma Clinical Studies
Testing is an important part of any product development, and ongoing research is also vital to the credibility of any product. At TBL-12 we believe that testing and research are vital to the continuation of our product and we are constantly sourcing new clinical trials to give weight to our claims.
TBL-12 is currently involved in two clinical trials assessing the value in using the product to treat Multiple Myeloma. There are more studies being planned to target other types of cancers and immune system related diseases.
Currently we have our main study underway at Mount Sinai in New York City. This was the one that began at St. Vincent’s in New York City, but was moved when the Multiple Myeloma Unit was moved to Mount Sinai. As well as this, we have a couple of new Studies being organised at New York University Cancer Institute (NYUCI). New York University Cancer Institute (NYUCI) researchers are searching for ways to modulate the immune system to fight multiple myeloma. Immunomodulatory drugs (ImiDs) are believed to work in part by stimulating the patient's immune system to attack and destroy myeloma cells.
NYUCI investigators are assessing therapies for asymptomatic myeloma in clinical trials, to delay the onset of active multiple myeloma. One of those treatments is TBL-12, a sea cucumber extract that is a food supplement that may modulate the immune system.
CURRENT STUDIES
We are not allowed to release any results of the studies until they have been completed. For more information on our current clinical studies please see below. Please check our research papers for results of clinical studies.
The details of our two main studies can be found below:
Study of TBL 12 Sea Cucumber Extract for Patients with Untreated Asymptomatic Myeloma
Sponsor: Mount Sinai Medical Center
Responsible Party: Sundar Jagannath, MD, Mount Sinai Medical Center
Collaborator: Unicorn Pacific Corporation
ClinicalTrials.gov Identifier: NCT01096810
Study Description
The purpose of this study is to see if the investigational food supplement TBL-12 which is a blend of Sea Cucumber, Sea Sponge, Shark Fin, and Sea Urchin (animals that lives in the Pacific Ocean) as well as Sargassum (a plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple myeloma and to see what the side effects are. This early form of multiple myeloma is not normally treated with drugs.
A Trial of TBL-12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
Sponsor: New York University School of Medicine
Responsible Party: Dr. Amitabha Mazumder, New York University School of Medicine
Collaborator: Unicorn Pacific Corporation
ClinicalTrials.gov Identifier: NCT01302366
Study Description
TBL-12 will be given orally at a dose of 2 units (of 20 mL each) twice a day, in 4 week cycles, until disease progression or until there is sign of disease progression. Each 'unit' is a liquid gel packaged in a 20 ml container sealed with an aluminium lid. All patients will initially receive 2 cycles of therapy (eight weeks), followed by re-staging with urine and/or serum protein assessments. The patient will continue being treated on study if their disease is stable or responding. All patients will then be re-staged four cycles later (end of cycle 6) with protein studies.
TBL-12 has been used by many customers as a food supplement without any side effects. This study proposes to determine the clinical activity of this agent in patients with asymptomatic multiple myeloma. It is believed that TBL-12 will help delay the onset of active multiple myeloma, with very few - if any - side effects.
TBL-12 is currently involved in two clinical trials assessing the value in using the product to treat Multiple Myeloma. There are more studies being planned to target other types of cancers and immune system related diseases.
Currently we have our main study underway at Mount Sinai in New York City. This was the one that began at St. Vincent’s in New York City, but was moved when the Multiple Myeloma Unit was moved to Mount Sinai. As well as this, we have a couple of new Studies being organised at New York University Cancer Institute (NYUCI). New York University Cancer Institute (NYUCI) researchers are searching for ways to modulate the immune system to fight multiple myeloma. Immunomodulatory drugs (ImiDs) are believed to work in part by stimulating the patient's immune system to attack and destroy myeloma cells.
NYUCI investigators are assessing therapies for asymptomatic myeloma in clinical trials, to delay the onset of active multiple myeloma. One of those treatments is TBL-12, a sea cucumber extract that is a food supplement that may modulate the immune system.
CURRENT STUDIES
We are not allowed to release any results of the studies until they have been completed. For more information on our current clinical studies please see below. Please check our research papers for results of clinical studies.
The details of our two main studies can be found below:
Study of TBL 12 Sea Cucumber Extract for Patients with Untreated Asymptomatic Myeloma
Sponsor: Mount Sinai Medical Center
Responsible Party: Sundar Jagannath, MD, Mount Sinai Medical Center
Collaborator: Unicorn Pacific Corporation
ClinicalTrials.gov Identifier: NCT01096810
Study Description
The purpose of this study is to see if the investigational food supplement TBL-12 which is a blend of Sea Cucumber, Sea Sponge, Shark Fin, and Sea Urchin (animals that lives in the Pacific Ocean) as well as Sargassum (a plant that lives in the Pacific Ocean), will have effects against asymptomatic multiple myeloma and to see what the side effects are. This early form of multiple myeloma is not normally treated with drugs.
A Trial of TBL-12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma
Sponsor: New York University School of Medicine
Responsible Party: Dr. Amitabha Mazumder, New York University School of Medicine
Collaborator: Unicorn Pacific Corporation
ClinicalTrials.gov Identifier: NCT01302366
Study Description
TBL-12 will be given orally at a dose of 2 units (of 20 mL each) twice a day, in 4 week cycles, until disease progression or until there is sign of disease progression. Each 'unit' is a liquid gel packaged in a 20 ml container sealed with an aluminium lid. All patients will initially receive 2 cycles of therapy (eight weeks), followed by re-staging with urine and/or serum protein assessments. The patient will continue being treated on study if their disease is stable or responding. All patients will then be re-staged four cycles later (end of cycle 6) with protein studies.
TBL-12 has been used by many customers as a food supplement without any side effects. This study proposes to determine the clinical activity of this agent in patients with asymptomatic multiple myeloma. It is believed that TBL-12 will help delay the onset of active multiple myeloma, with very few - if any - side effects.
