CCT Pharma, Inc. (a division of Cavitation-Control Technology, Inc. [Cav-Con]) is a privately-held biotechnology company, organized as a "virtual corporation" (and registered in Connecticut, USA), coordinating scientific collaborations with various laboratories and hospitals in the USA and overseas. Headed by its founder and chairman Dr. Joseph S. D'Arrigo, the company's principal business is in the targeted-delivery R&D area.
Between 1987 and 1993, Cav-Con received two SBIR Phase I awards and one Phase II award which together totaled $600,000 from the National Institutes of Health. These federal funds allowed Cav-Con to expand its medical research and development efforts to include collaboration on an extensive preclinical testing program in support of its flagship cancer medicine in development, Filmix® (see below). (This preclinical development work included pharmacology and toxicology studies in multiple animal species, resulting in science-journal publications on efficacy and industry reports on safety of Filmix®, as well as FDA-oriented chemistry, manufacturing, and control information studies of lab-scale production methods to supply clinical-quality drug.) The numerous journal publications which resulted from these DHHS supported studies has, in turn, directly assisted in attracting corporate licensing income (several times the level of all past SBIR funds) into Cav-Con Inc. during the past two decades, in addition to contract-research revenues and private-investor funds. The corporation's management confirms that 60% of this worldwide licensing income was from pharmaceutical companies headquartered overseas, and essentially all such licensing income is expended in support of CCT Pharma's ongoing Filmix® projects, i.e., both added preclinical development work as well as clinical coordination/support activities.
Under the SBIR program, Cav-Con Inc. began collaboration with both the University of Connecticut Health Center and Hartford Hospital, which required hiring additional research staff at both sites. This published collaborative work, along with additional work conducted at S.U.N.Y. Stony Brook and Brookhaven National Lab., demonstrated that Cav-Con's lipid-coated microbubble (LCM) technology (brandname “Filmix®”) could be employed effectively for: 1) earlier cancer diagnosis by enhanced ultrasound imaging and MRI contrast, 2) cavitation-therapy of tumors, and 3) especially for targeted-delivery of cancer therapeutics (such as Taxol) to tumors. Thereafter, a similar collaborative series of studies in larger animals (i.e., dogs with spontaneous tumors of various types) was also conducted successfully at the comparative oncology facilities of Colorado State University. In addition, Filmix® has received the following formal determinations from the Food and Drug Administration (in USA) and/or Institutional (clinical) Review Boards (IRB's) to date: 1) an official FDA "orphan drug designation" (#90-487) for one clinical indication (neurosonography) in humans; 2) formal classification of a veterinary version of the same product as a "veterinary device" by the FDA (and its product labeling deemed adequate); 3) an I.N.D. filed, with the FDA, for sonographic detection of prostate and liver tumors in humans, accompanied by IRB approval of the clinical protocol by the University of Massachusetts Medical Center; 4) University of Connecticut Health Center's IRB approval (by full Board for first phase) of clinical study on ultrasonic therapy of LCM-targeted liver tumors in humans.
Currently, CCT Pharma Inc. is participating in ongoing collaborative Filmix "LCM/nanoparticle" agent (Filmix® nanoemulsion) studies which include targeted drug-delivery to various tumors, as well as investigations on cavitation-therapy of, diagnostic imaging of, and endocytic (receptor-mediated) "Filmix nanoemulsion"-uptake pathways of solid tumors. [In effect, the LCM system (Filmix®) is an example of the technology of "closed-loop devices", a new paradigm in drug development and delivery emerging in pharmaceutical industry briefings and reports, which has been defined as the same device or technology providing not only diagnostics but guiding therapy and delivery of therapeutics.] The above collaborative studies all utilize the originally patented (and subsequently refined/confidentiality-safeguarded) LCM technology, and have encompassed preclinical and/or clinical facilities at several medical-research centers worldwide: a) University of Edinburgh, Royal Infirmary of Edinburgh, Scotland, U.K.; b) Yale University School of Medicine (Dept. of Therapeutic Radiology), New Haven, CT, USA; c) University of Connecticut Health Center (Div. of Gen. Surgery), Farmington, CT, USA; d) Hartford Hospital, Hartford, CT, USA; e) University Hospital Center in Angers, France; and f) Fukuoka University School of Medicine in Fukuoka, Japan. The most recent collaborative development work, using LCM for targeted cavitation-therapy as well as diagnostic imaging (monitoring) of solid tumors, has been carried out jointly by the University of Massachusetts Medical Center (Div. of Surgical Oncology, Dept. of Surgery) and Worcester Polytechnic Institute, Worcester, MA, USA.
SBIR has been central to Cav-Con's early growth. Because of SBIR research accomplishments, essentially all of Cav-Con's business over the past two decades has been with the private sector. The company's commercialization activities have yielded issued ("composition-of-matter" as well as "methods") patents, all owned exclusively by Cav-Con Inc., in 8 countries which include the United States (1987 & 1993), Canada (1990), Japan (1994), Australia (1995), United Kingdom (1997), Germany (1998), France (1997), and Italy (1997). CCT Pharma is currently interested in negotiating licensing-out of its confidential intellectual property concerning (one or more of) the following Filmix®-nanoemulsion product categories [available for fields or territories indicated]: targeted drug-delivery [available worldwide in fields other than cancer chemotherapy]; as well as targeted imaging, of solid tumors and selected hyperproliferative-disease sites [available in all countries].
To conclude with some general comments on relevant market sizes, several published figures can be cited here: Tumor imaging-agent sales in the USA already amount to a multi-billion-dollar market and several-fold larger globally [cf. Radiology 245:645-660 (2007)]; a large portion is attributed to clinical breast-tumor imaging alone. In addition, the current atherosclerotic-lesion imaging market is also very large [e.g., Eur. Heart J. 24:1462-1467 (2003)]. Moreover "TARGETED imaging", often combined with "TARGETED drug delivery", to tumors and atherosclerotic lesions form an ever-increasing portion of these domestic and global sales projections (and related R&D efforts).
D'Arrigo, J.S. (for registrant: Cav-Con, Inc.). United States Trademark No. 2,134,147 , i.e., use-based for "FILMIX®" (issued February 3, 1998).
LCM-technology (Filmix®) applications currently available for new business development:
A) Licensing-out of CCT Pharma's confidential intellectual property concerning DRUG-DELIVERY technology [available worldwide in fields other than cancer chemotherapy] TARGETING locations of certain hyperproliferative and/or inflammatory diseases, such as neuro-injury and neuroinflammation sites and/or cardiovascular injury/disease sites, using "LCM/nanoparticle-derived" nanoemulsions;
B) Licensing-out of CCT Pharma's confidential intellectual property concerning targeted IMAGING, of solid tumors and selected hyperproliferative-disease and/or neuroinflammation sites, using Filmix nanoemulsion agent.
BUSINESS DEVELOPMENT contact person at CCT Pharma, Inc.:
Joseph D'Arrigo, Ph.D.
E-mail: cavcon@ntplx.net