Five Eleven Pharma Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Abstract Five Eleven Pharma is developing a simple low cost device for automating the preparation of Ga labeled drugs at any site that is performing PET imaging The device is being developed to support the broader creation distribution research and use of Ga compounds in diagnostic PET imaging There has been a surge in the use of Ga based radiopharmaceuticals throughout the world in the past several years particularly in Europe where about centers provide various Ga investigational agents The success of these drugs first of Ga DOTATOC and related somatostatin receptor binding peptides and more recently agents targeting prostate cancer such as PSMA is fueling much of this expansion in Europe and similar growth is expected in the United States where DOTATOC received orphan drug status by the US FDA in Today however only a few academic sites in the US provide all the Ga based drugs needed to meet patient demand often through expanded access Investigational New Drug IND clinical trial protocols In many cases PET imaging with Ga labeled drugs are the best available diagnostic procedure available to patients for the detection of disease yet access to these new drugs is limited Because of the short half life min of Ga it will be difficult for existing radiopharmacy networks that were designed for distribution of radiopharmaceuticals with longer half lives andgt minutes to deliver Ga drugs efficiently On site preparation of Ga drugs is expected to grow in response to this distribution problem Five Eleven will meet this growing demand through a device that will require little expertise to operate and maintain and fully automates the process for producing a sterile injectable Ga radio labeled drug The device will be based on industry standard single use disposable components and will use no externally connected computer or other device to operate since it will have no changeable operating parameters Our aims for the project are to optimize the operating parameters of the device to effectively reduce the control system and hardware to bare minimums reducing cost significantly by X compared to existing systems Aim will evaluate fluid drive pressure vacuum flow rate and temperature to establish the sensitivity of the yield and purity of the final product to each of these parameters Develop a fully automated device based upon a minimum hardware configuration and fixed control system and Demonstrate an automated system by producing Ga compounds P PSMA and DOTATOC that meet all the quality criteria required by the FDA for injectable Ga labeled drugs pH tonicity radiochemical purity andgt radiochemical identity Ge content andlt radionuclidic purity radionuclidic identity and sterility Successful completion of this phase I will lead to full commercial development of a device in phase II with testing in a clinical study using either proprietary or generic new Ga drugs produced at the clinical PET imaging site Page of Narrative Short lived Ga based radiopharmaceuticals represent a major advance in cancer patient care using PET imaging The inefficiency and high cost of existing radiopharmaceutical distribution networks used to produce and deliver these new diagnostic agents via centralized radiopharmacies is limiting access to patients Five Eleven Pharma is developing a simple inexpensive Ga drug preparation device to allow production of Ga drugs at the site of use that will greatly expand the creation experimentation distribution and utility of these compounds for the detection and diagnosis of human disease Page of