Systemic Delivery of Insulin via an Enhancer-Free Ocular Device

Lee, Yung Chi; Simamora, Pahala; Yalkowsky, Samuel H.

doi:10.1021/js970191c

Cited by 31 publications

(18 citation statements)

References 14 publications

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“…Gelfoam is a collagen matrix prepared from purified pork skin collagen (23)(24)(25)(26). Preparation of the viral vectors in the Gelfoam for injections was performed as previously described (26).…”

Section: Delivery System and Immunizationsmentioning

confidence: 99%

Cutting Edge: Restoration of the Ability to Generate CTL in Mice Immune to Adenovirus by Delivery of Virus in a Collagen-Based Matrix

Siemens¹,

Elzey²,

Lubaroff

et al. 2001

The Journal of Immunology

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Viruses are commonly used for the delivery of genes coding for tumor-associated Ags to elicit tumor-specific immune responses. The success of viral vectors has been limited in preclinical and clinical trials in part because of antiviral immunity. We investigated the ability of a collagen-based matrix (Gelfoam; Pharmacia and Upjohn, Kalamazoo, MI) to improve CTL activation by recombinant adenovirus. The data show that coinjection of Gelfoam with type 5 adenovirus recombinant for prostate-specific Ag (Ad5-PSA) enhanced CTL activation. Ad5-PSA priming in Gelfoam also abrogated the inhibitory effects of adenoviral immunity on CTL activation in mice naive to PSA but immune to adenovirus. Finally, Gelfoam enhanced immunization in a self-Ag model using type 5 adenovirus recombinant for membrane-bound OVA (Ad5-mOVA) in rat insulin promoter (RIP)-mOVA-transgenic mice. Thus, Gelfoam enhances CTL activation by recombinant viral vectors in a setting where preformed Ab to the virus is present and also in a tolerant self-Ag model.

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Section: Delivery System and Immunizationsmentioning

confidence: 99%

Cutting Edge: Restoration of the Ability to Generate CTL in Mice Immune to Adenovirus by Delivery of Virus in a Collagen-Based Matrix

Siemens¹,

Elzey²,

Lubaroff

et al. 2001

The Journal of Immunology

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“…Commercially available Humulin R was selected as another source of zinc insulin and was used as an eyedrop as well as one device preparation. In this case, only 10% acetic acid solution-treated insulin devices were found to produce significant blood glucose reduction [Lee et al, 1997]. Morgan and Huntzicker [1996] administered regular porcine insulin as eye drops to healthy, euglycemic dogs.…”

Section: Introductionmentioning

confidence: 93%

Recent strategies and methods for improving insulin delivery

Lin

Gokhale

Trivedi³

et al. 2004

Drug Development Research

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Subcutaneous insulin has been used to treat diabetes since the discovery of insulin itself. However, despite a number of different formulations and routes of administration, intensive insulin therapy without limitations, such as too low bioavailability, has not enjoyed widespread clinical acceptance. Attempts to find effective, well-tolerated routes for delivering insulin began in the late 1920s and as of today, an ideal insulin delivery is still formidable. The most recent advances in insulin delivery are focused on using the inhalation route. The recent European filing of inhaled insulin (Exubera) is providing hope for alternative delivery routes, for example. This article reviews recent advances and approaches that hold promise toward the successful development of insulin delivery for the management of diabetes. Drug Dev.

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“…Lubaroff; final addendum report, page 31 Monitoring toxicity: Stopping rules for toxicity purpose are based on testing the null that toxicity level is less than 15% versus the alternative that it is actually greater than 35%. In this setting, we will carry two different but dependent looks.…”

Section: Protocol #1mentioning

confidence: 99%

“…Gelfoam has been used experimentally for the delivery of soluble proteins and drugs, including insulin, antibiotics, and growth factors (31)(32)(33). Gelfoam was used for sustained release of insulin in an ocular implant device (31).…”

Section: Protocol #2mentioning

confidence: 99%

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Vaccine Immunotherapy for Prostate Cancer. Addendum

Lubaroff¹

2007

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Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for Information Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO NOT RETURN YOUR FORM TO THE ABOVE ADDRESS. Lubaroff, final addendum report REPORT DATE 01-07-2007 REPORT TYPE Final Addendum DATES COVERED Appendices…………………………………………………………………………… 4Lubaroff; final addendum report, page 1. Vaccine Immunotherapy for Prostate Cancer David M. Lubaroff, PhD Principal Investigator Grant Number PC050647 Final Addendum ReportINTRODUCTION: The goal of this Clinical Trial Developmental Award (CTDA) was to develop and complete the required administrative tasks necessary to begin a Phase II clinical trial of an adenovirus/PSA (Ad/PSA) vaccine in men with recurrent prostate cancer and a Phase I clinical trial of the combination of the Ad/PSA vaccine along with immunostimulatory CpG ODN. The tasks included the design and construction of the clinical protocols, informed consent forms, submission to the institutional committees that include the Protocol Review and Monitoring Committee, Human Subjects Committee (IRB), Biosafety Committee, Pharmacy and Therapeutics Committee; the NIH Recombinant DNA Advisory Committee (RAC), and the food and Drug Administration (FDA). In addition, although not funded by the CTDA, we were required by the FDA to perform Pharmacology/Toxicology and Histopathology Studies and to obtain a complete DNA sequence of the Ad/PSA vaccine.BODY: We describe below the accomplishments during the one year extension of the award, using the original Statement of Work tasks. The accomplishments include those previously reported at the end of the original one year award.Sequence the Ad5-PSA vaccine -The clinical grade Ad/PSA vaccine was submitted to Lark Technologies. The sequence report indicated that there were no additions to the normal sequences of the PSA insert nor to the adenovirus backbone.Develop protocols, investigator brochures, and IRB forms for the Phase II trial of the Ad/PSA vaccine alone -This task consumed the great majority of time during the first year of the award. Multiple meetings were held among the Principal Investigator (PI) and members of the Clinical Trial Team to make important decisions about the trial protocols. The discussion point included the patient populations to be targeted in the trials, the...

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Systemic Delivery of Insulin via an Enhancer-Free Ocular Device

Cited by 31 publications

References 14 publications

Cutting Edge: Restoration of the Ability to Generate CTL in Mice Immune to Adenovirus by Delivery of Virus in a Collagen-Based Matrix

Cutting Edge: Restoration of the Ability to Generate CTL in Mice Immune to Adenovirus by Delivery of Virus in a Collagen-Based Matrix

Recent strategies and methods for improving insulin delivery

Vaccine Immunotherapy for Prostate Cancer. Addendum

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