IsoTherapeutics Group LLC

Angleton, TX, United States

IsoTherapeutics Group LLC

Angleton, TX, United States
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Patent
IsoTherapeutics Group LLC | Date: 2014-10-07

This invention relates to radioactive, bone-seeking, pharmaceutical methods, compositions and formulations that have a lower impurity profile, a longer shelf life, improved availability and are less expensive to prepare. The compositions of this invention can be conveniently prepared in a timely manner resulting in improved availability and delivery of the drugs to patients.


Patent
IsoTherapeutics Group LLC | Date: 2012-12-21

This invention concerns a pharmaceutically-acceptable composition of radioactive metals, which are used for treating various diseases in animals or humans, such as cancer and arthritis.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.49M | Year: 2013

DESCRIPTION provided by applicant There are roughly new cases of metastatic cancer to the skeleton in the U S each year andquot Bone seekingandquot radiopharmaceuticals are used for bone pain palliation and have shown promise for treating bone metastases They typically combine a radioactive metal such as samarium with a chelant The chelant part of the molecule is taken up by growing bone and carries the radioactive andquot payloadandquot along with it Approximately of the radioactivity in the radiopharmaceutical concentrates in bone and irradiates the adjacent tumor This radiation absorbed dose produces the therapeutic effect Two rare earth metal based bone seeking radiopharmaceuticals Sm EDTMP and Ho DOTMP have been investigated for treating bone tumors and have shown promising clinical results However one has an inefficient chelant that limits how much radioactivity can be delivered to the bone The other has a radionuclide that is too strong and causes intolerable side effects We are developing the bone seeking radiopharmaceutical CycloSam R Sm DOTMP for the treatment of bone metastases Compared to the two compounds that have already been tried CycloSam combines the better radionuclide samarium with the better phosphonic acid chelant DOTMP We anticipate that CycloSam will be able to deliver the prescribed radiation absorbed dose to bone tumors while avoiding intolerable radiation damage to normal non target tissues Phase II of this project will manufacture clinical grade CycloSam verify that the clinical grade CycloSam has the same biodistribution and dose delivery properties that we measured in Phase I and treat bone tumors using increasing quantities of clinical grade CycloSam to determine the maximum amounts that may be safely given with no clinically significant suppression of the bone marrow and with marrow suppression that is mild enough for spontaneous recovery Phase II will make clinical grade material under good laboratory practices GLP and current good manufacturing practices cGMP conditions The pharmacological toxicity of the clinical grade material will be tested in rats and dogs The biodistribution of the clinical grade material will be tested in rats The dose escalation study wil be performed in dogs that present to a veterinary clinic with osteosarcomas in order to estimate the maximum dosage at which concurrent chemotherapy might be given and the maximum dosage at which the expected myelosuppression would not require a bone marrow transplant These dosage thresholds combined with the dosimetry data will be used in the design of the protocols to be presented along with the manufacturing and toxicology data in an IND application to the FDA for the first human trials PUBLIC HEALTH RELEVANCE Bone metastases have been treated by radioactive drugs or radiopharmaceuticals Thus far their effects have been primarily palliative We are developing the radiopharmaceutical CycloSam R to act directly upon and resolve metastatic lesions in addition to providing pain palliation


Grant
Agency: Department of Energy | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 989.75K | Year: 2012

Samarium-153 (153Sm) has ideal nuclear properties for a variety of therapeutic applications; however, it is only available in low specific activity (radioactivity/weight) form. While large quantities can be made by the 152Sm(n,)153Sm reaction in a medium flux reactor such as at the University of Missouri Research Reactor Center (MURR), typical irradiation parameters result in less than 2% of the 152Sm target material being converted into 153Sm. Since chemical methods cannot be used to perform isotopic separation, this means that & gt;98% of the resultant pharmaceutical molecules are labeled with cold atoms and are therefore incapable of delivering the desired radiation-induced therapeutic effect. Electromagnetic isotope separation is routinely used in the production of enriched stable isotopes and in mass spectrometry; however, the successful development of an economically viable facility for processing relatively short-lived radioactive medical isotopes presents new challenges. Results of the Phase I project clearly indicate the technical feasibility of using this approach for processing 153Sm. Experimental ion source testing demonstrated high extracted Sm+ ion current, in excess of 1 mA. All key process steps were tested individually, including pre- and post- separation chemistry.


Grant
Agency: Department of Energy | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 149.48K | Year: 2011

When the stable samarium-152 (Sm-152) isotope is irradiated, radioactive samarium-153 (Sm-153) is produced through a neutron capture reaction in yields of only about 2%, and this radioactive, therapeutic isotope (Sm-153) cannot be separated from the much more abundant (~98%) non-radioactive isotope (Sm-152) by chemical methods. Successful development of a new process using electromagnetic mass separation will allow isolating the Sm-153 from the Sm-152 and other unwanted impurities, yielding high specific activity Sm-153 applicable for multiple therapeutic uses as well as recovering the target material Sm-152 for further irradiation and Sm-153 production. The radioisotope 153Sm (t1/2=46.3 h), produced through a neutron capture (n,) reaction, is used in radiopharmaceuticals and other nuclear medicine applications. The nuclear reactor at the University of Missouri has demonstrated that it can make large quantities of Sm-153; however the specific activity (SA, radioactivity per gram) is low relative to the large amount of target material152Smplus very small quantities of other unwanted europium contaminants. Chemical separation cannot be used to perform isotopic separation and the only approach that can be applied to increase the specific activity significantly (~50% or higher) is electromagnetic mass separation, i.e., performing isotopic purity by removing the unwanted isotopes. Further, with mass separation, not only can one collect the product of interest153Smimplanted on a material of choice for any necessary post-chemical processing, but the target isotope 152Sm can be collected for recycling in the irradiation step (see Figure 1). In addition, this approach is potentially applicable to other needed radiolanthanides. Phase I of the work will demonstrate the feasibility of this approach to increase the specific activity of the 153Sm based upon a thorough literature study and some experimental measurements, and will develop the concept of an appropriate facility from beginning to final product. In a subsequent Phase II project, a facility based upon the design concepts determine in Phase I will be constructed and installed at the MURR facility at the University of Missouri to produce high levels of 153Sm to be used in subsequent radiopharmaceutical studies by IsoTherapeutics Group, LLC (ITG). The final specifications of all facilities must meet the needs of the final commercial usage. The actual mass spectrometer facility is planned for positioning at the MURR facility, which is the nations sole supplier of 153Sm, and the MURR group plays an essential role in determining the final detailed specifications. The Advanced Applied Physics Solutions (AAPS) team will provide necessary technical expertise under appropriate documentation to protect their intellectual property provided to the collaborating groups. Commercial Applications and Other Benefits: IsoTherapeutics Group, LLC has applications for the final productradioisotopes of high specific activity. A current radiopharmaceutical using Sm-153 is Quadramet, a bone pain palliation agent. Sales of Quadramet in 2007 were $9.3 million, which was deemed to represent about 10% of its market potential (1). The limited use of Quadramet in part may be due to its limited availabilityTuesday through Thursdaydue to its low specific activity and the presence of long-lived europium contaminants that take the radiochemical out of specification after two half-lives. If successful the purified, high specific activity Sm-153 should increase and extend its shelf-life, making it available throughout the week. The higher specific activity Sm-153 will have greater applications in targeted radiotherapy, such as with peptides and antibody fragments, where tumor cell receptors for the drug are limited


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 143.58K | Year: 2010

DESCRIPTION (provided by applicant): Bone-seeking radiopharmaceuticals are used extensively for bone pain palliation and have shown promise for treating bone metastases. They typically combine a radioactive metal such as samarium-153 with a chelator. The chelator part of the molecule is taken up by growing bone and carries the radioactive payload along with it. Approximately 50% of the radioactivity in the radiopharmaceutical concentrates in bone. The radioactive atoms that are taken up by the bone irradiate the adjacent tumor and micrometastases. This radiation absorbed dose produces the therapeutic benefit. Two bone-seeking radiopharmaceuticals have been investigated for treating bone tumors and micrometastases and have shown promising clinical results but they have proven to be either too weak or too strong. One has an inefficient chelator that limits how much radioactivity may be delivered to the bone. The other has a radionuclide that is so strong that it causes intolerable side effects. We are developing the radiopharmaceutical, samarium-153-DOTMP (CycloSamTM), for the treatment of bone metastases. Compared to the two compounds that have already been tried, CycloSam combines the better radionuclide, samarium-153, with the better phosphonic acid chelator, DOTMP. We anticipate that CycloSam will be able to deliver the prescribed radiation absorbed dose to bone tumors and micrometastases while avoiding intolerable irradiation of normal tissues. Phase I of our work will demonstrate that 1. CycloSam may be used at whatever strength is needed to achieve the prescribed treatment, 2. CycloSam has the requisite biological distribution properties to enable it to deliver high radiation to the skeleton and low radiation to the rest of the body, and 3. CycloSam concentrates in bone tumors even more than in normal bones. In this Phase I proposal, we will measure the time- and concentration-dependent biodistribution properties of CycloSam and theoretically assess its curative capability in rats in Aims 1 and 2. In Aim 3, we will administer CycloSam to dogs with osteosarcomas to demonstrate its concentration in skeletal lesions. In Phase II, we will perform dose escalation, efficacy and late effects studies in dogs and toxicology studies. In Phase III we will conduct clinical trials. PUBLIC HEALTH RELEVANCE: Bone metastases have been treated by radioactive drugs, or radiopharmaceuticals. Thus far, their effects have been primarily palliative. We are developing the radiopharmaceutical, CycloSamTM, to act directly upon and resolve metastatic lesions instead of providing only pain palliation.


Patent
IsoTherapeutics Group LLC and Gabriel Institute Inc. | Date: 2010-04-05

This invention provides a safer and more effective treatment for non-intracavitary undesirable tissue masses, especially bone cancer and soft tissue tumors. The method involves the direct administration of a therapeutically-effective dose of a formulated radioisotope composition nearby or directly into the tissue mass. Small volumes of the composition are used. Administration of the dose for bone cancer may be done through a hole or multiple holes created in the bone using a miniature drill. Delivery of the dose directly into a tumor may be accomplished using a microsyringe or a miniature pump capable of accurately delivering microliter amounts of material.


Patent
Gabriel Institute Inc. and IsoTherapeutics Group LLC | Date: 2012-05-11

This invention provides a safer and more effective treatment for non-intracavitary undesirable tissue masses, especially bone cancer and soft tissue tumors. The method involves the direct administration of a therapeutically-effective dose of a formulated radioisotope composition nearby or directly into the tissue mass. Small volumes of the composition are used. Administration of the dose for bone cancer may be done through a hole or multiple holes created in the bone using a miniature drill. Delivery of the dose directly into a tumor may be accomplished using a microsyringe or a miniature pump capable of accurately delivering microliter amounts of material.


Trademark
IsoTherapeutics Group LLC | Date: 2012-02-28

Radioactive pharmaceutical preparations for use in vivo diagnostic or therapeutic use. Chemistry consultation.


Trademark
IsoTherapeutics Group LLC | Date: 2012-01-31

Radioactive pharmaceutical preparations for use in vivo diagnostic or therapeutic use.

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