Regulon SA

Regulon is a biotechnology company that is committed to the discovery and development of low-toxicity anticancer biopharmaceuticals based on its unique proprietary liposome encapsulation platform technology.

The company is headquartered in Athens, Greece (Regulon AE), and has a wholly owned subsidiary in Moscow, Russia. The company also maintaines legal and operational presence in the United States, with offices in San Francisco and New York City.

Regulon has successfully applied its technology to encapsulate members of the platinum family of anticancer drugs. Platins are the cornerstone of modern chemotherapy, as they are commonly applied in the effective treatment of a great many tumors since 25 years. Despite their well-documented efficacy, however, platinum treatment almost invariably results in pronounced toxicity against the patient's kidneys, nerves, blood, or hearing system. Thus, generating platins of lower toxicity and /or higher efficacy (higher therapeutic index) is an unmet medical need in cancer chemotherapy.

R&D

In 1999, Regulon encapsulated the prototype of the platins, cisplatin, to generate Lipoplatin^TM. Extensive preclinical testing of Lipoplatin^TM demonstrated that the great majority of cisplatin's side effects are significantly attenuated in Lipoplatin^TM. More interestingly, Lipoplatin^TM has been shown to preferentially target and fuse with human tumor tissues, thereby delivering its cytotoxic payload more specifically than does naked cisplatin. Phase I and phase II clinical trials of Lipoplatin^TM suggest that Lipoplatin^TM eliminates cisplatin toxicity while maintaining or even improving efficacy in cancer patients. Lipoplatin^TM is currently undergoing advanced clinical trials for selective cancer indications, such as lung, pancreatic and head & neck cancer.

Regulon's proprietary encapsulation technology was further exploited in the generation of Lipoxal^TM in 2003. Like Lipoplatin^TM, Lipoxal^TM is a proprietary liposomal form of oxali-platin (or Eloxatin^TM, a trademark belonging to sanofi-aventis, that goes off patent in 2007 in some European countries.) Preclinical testing and Phase I clinical trials in Greek cancer patients suggest Lipoxal^TM has a higher therapeutic index than oxaliplatin. Hence, the further development of Lipoxal^TM is warranted and Regulon is about to begin a Phase II evaluation of Lipoxal^TM for gastric or biliary cancer in Greece, Germany and elsewhere.

Regulon's third clinical candidate is a distinct, yet particularly appealing technical advance. Regulon's LipoVIL12^TM contains a liposomally encapsulated recombinant Semliki Forest Virus harbouring the coding sequences of human interleukin 12. Given the purported role of IL12 in cancer and viral infections, Regulon hopes to be able to demonstrate a sounding role for LipoVIL12^TM in cancer gene therapy. LipoVIL12^TM has finished a phase I/II trial in glioblastoma patients with promising results. The unique platform technology of Regulon could (and will) be further applied to the generation of other liposomal cytotoxics. In addition, Regulon maintains an active novel platin drug discovery platform, while it initiated an RNAi project in 2007.

Target partners & Collaborations

Regulon is in discussions with academic institutions as well as private companies on selective co-operative research & development agreements.