The Norwegian pharmaceutical company Lytix Biopharma AS announced approvals from the Norwegian Medicines Agency (”Statens legemiddelverk”) and the Swedish Medical Products Agency (”Läkemedelverket”) to commence Phase I clinical trials of OncoporeTM (LTX-315) for the treatment of cancer.

According to Lytix Biopharma CEO Gunnar Sælid, “We are delighted to announce the regulatory approval by the Norwegian and Swedish Authorities to test our very interesting experimental drug OncoporeTM (LTX-315) in the clinic. I am extremely pleased with the efforts put in by our Drug Development teams this year, with all projects progressing well according to our plans. For the Company this is an important study, validating the attractiveness of our platform in oncology. We will now have two programs in clinical trials; on the one hand our topical antimicrobial drug, and now our novel treatment for cancer”.

In preclinical models LTX-315 has demonstrated the ability to effect necrotic killing of cancer cells. Simulatenously it also causes the release of danger signals from the stressed and dying cells that trigger a beneficial activation of the immune system.

“The study will start in the beginning of 2010 and will be run at two centers, The Norwegian Radium Hospital - National Hospital in Oslo, as well as the Karolinska University Hospital in Stockholm, Sweden. Initially, the Phase I study will establish a safe and tolerated dose of LTX-315 when given to solid tumours amenable to injection. OncoporeTM (LTX-315) has the potential to becoming a valuable new agent for the treatment of cancer”, says Jon Amund Eriksen, Director of Product Development, Oncology at Lytix Biopharma AS. The clinical trial is supported by grants from The Norwegian Cancer Association (”Kreftforeningen”), The Norwegian Research Council (”Forskningsrådet”) and Innovation Norway (”Innovasjon Norge”).

About OncoporeTM (LTX-315)

LTX-315 is an investigational treatment for cancer based on the biological principle of innate immune effectors, lytic peptides. The drug recognises charges in cell membranes and, in a dose dependent manner, induces immunogenic cell stressing and rapid cell lysis. When injected intra-tumorally LTX-315 causes dramatic and rapid cell lysis and tumour necrosis. The drug has been tested in in vitro and in vivo models, and has undergone formal preclinical safety and toxicology studies. The Phase I/II study is expected to commence in the beginning of 2010.

Source
Lytix Biopharma AS

Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced that the European Medicines Agency (EMEA) has approved its Phase 3 protocol for Onalta (Yttrium-90 edotreotide). Onalta is the Company’s lead radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. The compound has shown the potential to selectively deliver lethal radiation to cancer cells. The proposed Phase 3 trial will confirm that administration of Onalta results in stabilization, regression or complete remission of the carcinoid tumor, and improves carcinoid-related symptoms when compared to a high-dose regimen of the current standard therapy for this disease, Sandostatin®. With EMEA’s approval of its proposed Phase 3 protocol in hand, Molecular Insight can proceed with the final clinical trial that will position Onalta for marketing authorization in the EU.

EMEA notified Molecular Insight that its Onalta Phase 3 protocol is acceptable, including the plan to assess and manage renal tolerance, that the endpoints and measures are appropriate, and that the number of patients proposed to be presented in support of safety for the future Marketing Authorization Application (MAA) is acceptable.

John W. Babich, Ph.D., Executive Vice President, Chief Scientific Officer and President of Research and Development of Molecular Insight, said that, “This is a significant Company milestone that allows us to proceed with a pivotal trial for Onalta in Europe. A successful trial would mean an innovative and well-understood therapy could be made available to thousands of patients whose lives are being cut short and who suffer from the debilitating symptoms that accompany this disease.

“The notification by EMEA comes on the heels of our Special Protocol Assessment (SPA) agreement with FDA allowing us to proceed to a pivotal phase 2 trial for Azedra™ Ultratrace™ (Iobenguane I-131) in another neuroendocrine cancer, pheochromocytoma. Azedra is also currently being evaluated for treatment of neuroblastoma. These drug candidates represent significant opportunities to provide neuroendocrine cancer patients with innovative therapies. Molecular Insight has selected Progression Free Survival (PFS) as the primary endpoint for the proposed Phase 3 study and overall survival will be assessed as a key secondary endpoint. The regulatory progress in Europe will hopefully be followed by regulatory progress in the USA.”

According to Dr. Val Lewington, Consultant Physician, Royal Mardsen NHS Foundation Trust, “EMEA approval of this Phase 3 protocol represents a landmark in radionuclide therapy. The potential of this approach is well-recognized in Europe but this will be the first opportunity to evaluate this peptide-based radiotherapy in a major, multi-center, randomized clinical trial. It is difficult to overstate the importance of this step in the development of innovative therapies for inoperable neuroendocrine tumors which so often prove refractory to other treatment options. News of the EMEA decision will be welcomed enthusiastically both by clinicians and by patients with neuroendocrine disease.”

The proposed Phase 3 protocol will evaluate 194 patients with metastatic, progressive, somatostatin receptor-positive, carcinoid cancer, receiving either Onalta or the standard of care. Carcinoid cancer is a rare, serious and life-threatening condition that affects a group of patients with few treatment options. Once the disease has metastasized, the patients’ prognosis is poor: the best five-year survival rate is reported to be 20 - 30 percent.

Onalta is intended to complement Azedra™, Molecular Insight’s other clinical stage radiotherapeutic candidate for the treatment of neuroendocrine tumors. In 2007, Molecular Insight acquired Onalta from Novartis Pharma AG, which had conducted three Phase 1 and three Phase 2 clinical trials involving more than 300 patients.

About Onalta

Molecular Insight has been developing Onalta as a treatment for metastatic pancreatic neuroendocrine and carcinoid tumors in patients whose symptoms are not controlled by current somatostatin analogue therapy. Neuroendocrine tumors are a type of cancer that arises from neuroendocrine cells and can occur in different parts of the body. A somatostatin analogue is a synthetic compound, in this case a peptide, which functions in the body in a manner similar to the hormone somatostatin, which regulates a variety of other metabolic hormonal functions. Onalta binds selectively to tumor cells that have receptors for the peptide hormone somatostatin on their surface and serves as a carrier for targeted delivery of a lethal dose of radiation to the cancer cells through the radioactive decay of yttrium-90. The compound has been used to treat patients in Europe on an investigative basis for more than 10 years. There are no approved treatments in the U.S. for metastatic neuroendocrine tumors.

Source
Molecular Insight Pharmaceuticals, Inc.