TIKOMED STARTS CLINICAL PHASE I/II STUDY WITH TM-400 FOR TREATMENT OF HEMATOLOGIC CANCER
TikoMed initiates a phase I/II study at CTC, Sahlgrenska hospital in Gothenburg. The study documents TikoMeds orphan drug, TM-400, which can improve hematopoietic stem cell transplantation for patients with hematopoietic cancer.
Viken, Sweden–TikoMeds in house developed orphan product TM-400 can improve the outcome of hematopoietic stem cell transplantation (HSCT) for patients with hematopoietic cancer. The treatment increases the harvest of stem cells and is improving the cell-mixture for the transplantation. Studies have documented that the product has a superior profile versus current treatment and that its effects has the potential to promote cure for hematological cancers such as Multiple Myeloma and Non-Hodgkins Lymphoma. The study will document the safety and efficacy of TM-400 in healthy volunteers, is performed at CTC, Sahlgrenska hospital in Gothenburg and will be finalized in November 2013.
“We have through in-house development taken TM-400 from invention to clinical phase. It is a receipt of the innovative skills, business model and competences of TikoMed to reach far with limited resources. This clinical study is a significant step towards commercialization. With clinical efficacy data from this study we aim to reach license agreements during the coming year. Our business model is to drive development up to early clinical phases, thereafter the licensors will fund the more costly phase II/III studies”, said Anders Waas, CEO of TikoMed.
About Hematopoietic Stem cell transplantation (HSCT)
HSCT is a routine procedure with more than 60,000 patients treated yearly in the world. It is most commonly used for the treatment of hematological cancers such as Multiple Myeloma and Non-Hodgkins Lymphoma and also used for some other severe diseases. There is a high unmet need to improve the therapy as currently a significant portion of the patients receiving HSCT have recurrence of cancer resulting in high mortality rate.
During a HSCT hematological stem cells are harvested from the blood, either from the patient (auto-transplantation) or from a donor (allo-transplantation), to be transplanted to the patient after ablation. The “transplantation” is managed as a transfusion to the patient.
About Orphan Designation
The Food and Drug Administration (FDA) in the US and European Medicines Agency (EMA) in EU grants orphan drug designation for new therapies being developed to treat rare and severe diseases or conditions that affect fewer than 200,000 people in the US and less than five in 10,000 people in the EU. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year respectively 10 years period of market exclusivity in the US and EU after product approval. Hence, TikoMeds products TM-400 and IBsolvMIR® will not meet any generic competition during this period.
Swedish-based TikoMed is an innovation driven Biotechnology Company developing and commercializing life-saving products for severe diseases. Product development aims to quickly document effects in pre-clinical trials and early clinical studies. TikoMed strategy is to out-license its products to pharma companies, thereby optimizing commercialization. Through early out-licensing, TikoMed limits its risk and avoids later stage development and commercial costs. The board includes Anders Milton, former chairman of Swedish Red-Cross and Q-Med, Jan Sandström, previously Vice President Business Development at AstraZeneca and Gillis Johnsson, previously Medical Director at AstraZeneca. TikoMed has two orphan pharma-products in clinical development:
IBsolvMIR® (Orphan Drug Status in the US and EU), prevents that transplanted islet-cells are attacked and destroyed by the immune system (IBMIR). An ongoing Phase II clinical study has gained a $15 million grant from the National Institutes of Health (NIH) through Uppsala University, Sweden. Results from the study are expected in 2013.
TikoMed and Baylor Research Institute made an agreement, February 2013 to perform a phase II study in patients with chronic pancreatitis receiving auto islet cell transplantation. The disease is difficult to treat, very painful and life threatening. Current therapies are mainly analgesics to limit the pain. In aggregate approximately 400 000 inhabitants suffer from this condition in the US and EU. The market potential for IBsolvMIR® has been assessed to be larger than $200m.
TM–400 (Orphan Drug Status in the US and EU), is a product to improve the outcome of hematopoietic stem cell transplantations (HSCT) by increasing eradication of cancer and survival. There is a high unmet need to improve HSCT. The product can transform HSCT to a curing treatment. The market potential for TM-400 is assessed to larger than $400m.
For more informati on, please visit www.TikoMed.com .
Anders Waas (CEO)
Adam Bruce (Chairman)