Previously, we showed that rodent muscle has the ability to take up and express plasmid genes injected intramuscularly. This study now demonstrates that nonhuman primate muscle also has this ability to express injected plasmids. A scaled-up version of the standard large preparation of plasmid DNA allowed several tens of milligrams of CCC plasmid DNA to be relatively easily produced and administered to monkeys. After the injection of the E. coli beta-galactosidase reporter gene in pRSVLac-Z, foreign gene expression was localized to both type I and type II myofibers. The luciferase reporter gene in pRSVL was used to quantify the amount of expression. The multiple implantation of plasmid DNA pellets was more efficient in expressing luciferase than the injection of DNA in normal saline. Luciferase activity persisted for at least 4 months after injection. However, the luciferase expression was considerably less than that in rodents. Preliminary studies explored why expression was less in monkeys. Of particular interest was the increased thickness of the perimysium of monkeys as compared to that in rodents. This increased connective tissue may decrease delivery of the plasmid DNA to the myofibers. Anti-nuclear or anti-DNA antibodies were not observed, even after repetitive DNA administrations, and no adverse effects were observed in any of the monkeys.

Introduction. Poly( -caprolactone) (PCL) is currently being investigated for use in medical devices and pharmaceutical controlled release systems because of its biocompatibility, biodegradability, and good drug penetrability. [1][2][3] PCL is usually synthesized by ringopening polymerization (ROP) of -caprolactone ( -CL), which is carried out in the presence of metal-contained 4-8 or metal-free compounds. [9][10][11][12][13] The ROP can be initiated by active hydrogen of amine and alcohol, [14][15][16] and the effect of active hydrogen on the polymerization is enhanced by an organic acid. Rozenberg obtained PCL with molecular weight over 8000 g/mol from the polymerization of -CL initiated by aniline in the presence of a protonic acid. 17 Xie et al. revealed that the polymerization of -CL in the presence of hydroxyl acid was a hydroxyl-initiated reaction, and the carboxyl group did not initiate but accelerated the polymerization. 18 Sanda et al. carried out the polymerization of -CL with alcohols as initiators and fumaric acid as an activator of the monomer. 19 Recently, we investigated the ROP of -CL in the presence of natural amino acids considering that they are essential components in human nutrition, and the biocompatibility and in vivo safety of thus-obtained PCL must be satisfying for medical and pharmaceutical purpose. The results, which are presented in this paper, indicate that polymerization of -CL was initiated by the amino group of amino acid (Scheme 1).Experimental Section. -CL (Aldrich) was dried over calcium hydride for 48 h and distilled under reduced pressure. 1,4-Dioxane was purified by distillation after drying with sodium. All other materials were analytical grade and used as received.1 H NMR spectra of PCL were recorded on a Mercury VX-300 (300 Hz) apparatus with tetramethylsilane (TMS) as internal standard and CDCl 3 as solvent. Number-average molecular weight by GPC (M n,GPC ) and polydispersity index (M w /M n ) of PCL were measured with a Waters high-performance liquid chromatography system equipped with a model 2690D separation module, a model 2410 refractive index detector, and Shodex K802.5 (pore size 60 Å) and Shodex K805 (pore size 500 Å) columns in series. The measurements were per-

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A polymer (Mw3000 g mol−1 with Mw/Mn 1.2) was obtained by the copper‐catalyzed nitrogen‐elimination of allyl diazoacetate. Its structure was determined as poly(carballyloxycarbene) (PCACB) by 1H and 13C NMR and IR spectroscopy. © 2002 Society of Chemical Industry

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