Radio – Pharmacy

A centralized production facility for ready to use radio pharmaceuticals for the local market

in our radio- pharmacy are highly experienced and renowned experts in the area of Nuclear Medicine and Molecular Imaging. The team includes Radio pharmacists, Nuclear Engineers, Chemists, Technicians and logistics experts.

In our state of the art facility we produce short lived PET and SPECT radio pharmaceuticals and Lu177 PSMA& DOTA for therapy. We implement the highest level of isotope production methods, radio chemical synthesis, purification, and quality control. Isotopia uses it’s own logistics teams, certified by the competent authorities for preparing the doses in the safest and most practical method for delivery to the local market.

we operate a 16.4MeV GE cyclotron, 7 Ga68 generators and Tc99m generators.

Our radio pharmaceutical production quality assurance system ensures that we deliver a quality dose, in compliance with the requirements of the health authorities, coupled with safety measures and on-time delivery.

We are interested in collaboration with the medical & scientific community to further develop and trial new markers in molecular imaging.

FDG

F-DOPA

F-PSMA

Ga-68 DOTA

Ga-68 PSMA

  • Tc-99m Sulfur colloid
  • Tc-99m Filtered Sulfur colloid
  • Tc-99m ECD
  • Tc-99m DMSA
  • Tc-99m MAG-3
  • Tc-99m Nanocolloid HSA
  • Tc-99m MIBI
  • Tc-99m mIBG

Lu-177 PSMA

Lu-177 DOTA

·         TroDate 

·         ECD

·         DMSA

·         MAG-3

·         EHIDA

·         Nanocolloid HSA

·         MIBI (Stamicis)

·         S.C

·         PYP

·         RBC

Isotopia provides two main Theranostic products: 177Lu-Octerotide (for neuroendocrine tumors known as 177Lu-Dota-Tate\Toc) and 177Lu-PSMA (for Prostate cancer).
What is Theranostics?
The term theranostics is a combination of a diagnostic tool that helps to define a right therapeutic tool for specific disease and paves the approach towards personalized or precision medicine.
Lu-PSMA Treatment:
Between February 2013 and December 2018, 177Lu-PSMA (I&T and 617) PRLT was performed on 321 patients (main age 71 ± 7.4 years, mean Gleason score 8 ± 1) with progressive prostate cancer. Previous treatments included surgery (n=202), androgen deprivation therapy/ADT (n=295), radiotherapy (n=227), chemotherapy (n=149) and other interventions (n=42).
A total of 988 cycles of 177Lu-RLT were administered (main dosage/cycle was 6.71 GBq). Any PSA decline was observed in 188/265 (71%), best response was biochemical complete remission (PSA=0.0 ng/ml). Decrease in PSA by more than half was seen in 136 (50%) patients. Median progression-free survival (according to RECIST 1.1) was 9.8 months. Median overall survival (at 61 months follow-up) was 30.9 months. In general, the patients tolerated the 177Lu-PRLT treatment very well with no severe acute or long-term side effects (observation period of 64 months)
Adverse events: less than 10% of patients experienced grade 3/4 hepatotoxicity (Richard P. Baum*)
Since 2016, Isotopia has established the treatment of 177Lu-PSMA and provide this treatment in 3 main medical centers in Israel: SHEBA Medical Center\ ICHILOV Medical Center and RAMBAM Medical Center – During this period, dozens of patients have already received this treatment.
Our main goal is to provide the treatment to every patient who meets the eligibility criteria for this breakthrough treatment in the State of Israel.
Lu- Octerotide (Lu-Dotatate\Toc):
Lu-177 Octreotate is used as a treatment for patient with tumors that emerge from the endocrine or nervous system, called neuroendocrine tumors (NETs) or carcinoids. The main aim of this therapy is to reduce the size of the tumor, as well as to ease the symptoms that people may develop with these tumors.
On January 26, 2018, the FDA approved lutetium Lu 177 dotatate (LUTATHERA) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Approval was based on data from NETTER-1** phase III – the major efficiency outcome measure was progression free survival (PFS) determined by a blinded independent radiology committee using RECIST 1.1. The median PFS was not reached for lutetium Lu 177 dotatate and was 8.5 months in the high-dose long-acting octreotide arm (hazard ratio 0.21; 95% CI: 0.13, 0.32; p<0.0001). the most common grade 3/4 adverse reactions occurring with a greater frequency (at least 4%) among patients receiving lutetium Lu 177 dotatate with long-acting octreotide compared to patients receiving high-dose octreotide alone included lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea and elevated AST (5% each), and increased ALT, hyperglycemia, and hypokalemia (4% each).

The recommended dose of lutetium Lu 177 dotatate is 7.4 GBq (200 mCi) as an intravenous
infusion over 30 minutes every 8 weeks for a total of 4 doses.
As a Radio Pharmaceutical company, Isotopia has the ability to provide all kinds of theranostics treatments according to the doctors needs including Lu-Octreotide (Dotatate\Toc)
*HERANOSTICS Center for Molecular Radiotherapy and Precision Oncology, ENETS Center of Excellence, Zentralklinik Bad Berka, Germany
** Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors Jonathan Strosberg, M.D., Ghassan El-Haddad, M.D., Edward Wolin, M.D., Andrew Hendifar, M.D., James Yao, M.D., Beth Chasen, M.D., Erik Mittra, M.D., Ph.D., Pamela L. Kunz, M.D., Matthew H. Kulke, M.D., Heather Jacene, M.D., David Bushnell, M.D., Thomas M. O’Dorisio, .D., et al., for the NETTER-1 Trial Investigators*

The Marketing Unit is responsible for the marketing of imaging materials and treatment in the field of nuclear medicine.

The unit works with a wide range of health and medical personnel such as oncologists / neurologists / nuclear medicine professionals and the public.

The marketing unit consists of professional and experienced workers, all from the pharma field with academic degrees. The team undergoes in depth training in nuclear medicine field.

Today, the unit consists of a medical consultant, product managers and medical representatives.

Marketing operations include:

– Creating marketing channels be meeting with potential customers.

– Organic promotion of products by continuous meetings with key opinion leaders in the field.

– Participation in local and international conferences.

– organizing round table meetings with leading experts in Israel from various fields.

– launching of new products.

– Including products into the health care service for reimbursement (such as F-18-DOPA)

– Cooperation and support to and with health organizations.

 

One of the most important marketing goals is to establish new and cutting edge products while thinking about patients, as well as to enable personalized diagnosis and treatment.

With the above, the marketing unit must reflect high quality, reliability and the highest professionalism to all our customers.

FDG

F-DOPA

F-PSMA

Ga-68 DOTA

Ga-68 PSMA

  • Tc-99m Sulfur colloid
  • Tc-99m Filtered Sulfur colloid
  • Tc-99m ECD
  • Tc-99m DMSA
  • Tc-99m MAG-3
  • Tc-99m Nanocolloid HSA
  • Tc-99m MIBI
  • Tc-99m mIBG
  • Lu-177 PSMA

    Lu-177 DOTA

  •  TroDate 

    ·         ECD

    ·         DMSA

    ·         MAG-3

    ·         EHIDA

    ·         Nanocolloid HSA

    ·         MIBI (Stamicis)

    ·         S.C

    ·         PYP

    ·         RBC

Isotopia provides two main Theranostic products: 177Lu-Octerotide (for neuroendocrine tumors known as 177Lu-Dota-Tate\Toc) and 177Lu-PSMA (for Prostate cancer).
What is Theranostics?
The term theranostics is a combination of a diagnostic tool that helps to define a right therapeutic tool for specific disease and paves the approach towards personalized or precision medicine.
Lu-PSMA Treatment:
Between February 2013 and December 2018, 177Lu-PSMA (I&T and 617) PRLT was performed on 321 patients (main age 71 ± 7.4 years, mean Gleason score 8 ± 1) with progressive prostate cancer. Previous treatments included surgery (n=202), androgen deprivation therapy/ADT (n=295), radiotherapy (n=227), chemotherapy (n=149) and other interventions (n=42).
A total of 988 cycles of 177Lu-RLT were administered (main dosage/cycle was 6.71 GBq). Any PSA decline was observed in 188/265 (71%), best response was biochemical complete remission (PSA=0.0 ng/ml). Decrease in PSA by more than half was seen in 136 (50%) patients. Median progression-free survival (according to RECIST 1.1) was 9.8 months. Median overall survival (at 61 months follow-up) was 30.9 months. In general, the patients tolerated the 177Lu-PRLT treatment very well with no severe acute or long-term side effects (observation period of 64 months)
Adverse events: less than 10% of patients experienced grade 3/4 hepatotoxicity (Richard P. Baum*)
Since 2016, Isotopia has established the treatment of 177Lu-PSMA and provide this treatment in 3 main medical centers in Israel: SHEBA Medical Center\ ICHILOV Medical Center and RAMBAM Medical Center – During this period, dozens of patients have already received this treatment.
Our main goal is to provide the treatment to every patient who meets the eligibility criteria for this breakthrough treatment in the State of Israel.
Lu- Octerotide (Lu-Dotatate\Toc):
Lu-177 Octreotate is used as a treatment for patient with tumors that emerge from the endocrine or nervous system, called neuroendocrine tumors (NETs) or carcinoids. The main aim of this therapy is to reduce the size of the tumor, as well as to ease the symptoms that people may develop with these tumors.
On January 26, 2018, the FDA approved lutetium Lu 177 dotatate (LUTATHERA) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Approval was based on data from NETTER-1** phase III – the major efficiency outcome measure was progression free survival (PFS) determined by a blinded independent radiology committee using RECIST 1.1. The median PFS was not reached for lutetium Lu 177 dotatate and was 8.5 months in the high-dose long-acting octreotide arm (hazard ratio 0.21; 95% CI: 0.13, 0.32; p<0.0001). the most common grade 3/4 adverse reactions occurring with a greater frequency (at least 4%) among patients receiving lutetium Lu 177 dotatate with long-acting octreotide compared to patients receiving high-dose octreotide alone included lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea and elevated AST (5% each), and increased ALT, hyperglycemia, and hypokalemia (4% each).

The recommended dose of lutetium Lu 177 dotatate is 7.4 GBq (200 mCi) as an intravenous
infusion over 30 minutes every 8 weeks for a total of 4 doses.
As a Radio Pharmaceutical company, Isotopia has the ability to provide all kinds of theranostics treatments according to the doctors needs including Lu-Octreotide (Dotatate\Toc)
*HERANOSTICS Center for Molecular Radiotherapy and Precision Oncology, ENETS Center of Excellence, Zentralklinik Bad Berka, Germany
** Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors Jonathan Strosberg, M.D., Ghassan El-Haddad, M.D., Edward Wolin, M.D., Andrew Hendifar, M.D., James Yao, M.D., Beth Chasen, M.D., Erik Mittra, M.D., Ph.D., Pamela L. Kunz, M.D., Matthew H. Kulke, M.D., Heather Jacene, M.D., David Bushnell, M.D., Thomas M. O’Dorisio, .D., et al., for the NETTER-1 Trial Investigators*

The Marketing Unit is responsible for the marketing of imaging materials and treatment in the field of nuclear medicine.

The unit works with a wide range of health and medical personnel such as oncologists / neurologists / nuclear medicine professionals and the public.

The marketing unit consists of professional and experienced workers, all from the pharma field with academic degrees. The team undergoes in depth training in nuclear medicine field.

Today, the unit consists of a medical consultant, product managers and medical representatives.

Marketing operations include:

– Creating marketing channels be meeting with potential customers.

– Organic promotion of products by continuous meetings with key opinion leaders in the field.

– Participation in local and international conferences.

– organizing round table meetings with leading experts in Israel from various fields.

– launching of new products.

– Including products into the health care service for reimbursement (such as F-18-DOPA)

– Cooperation and support to and with health organizations.

 

One of the most important marketing goals is to establish new and cutting edge products while thinking about patients, as well as to enable personalized diagnosis and treatment.

With the above, the marketing unit must reflect high quality, reliability and the highest professionalism to all our customers.