Frederick County Biotech Community

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Archive for May 28th, 2009

Opportunities Abound!

Posted by Jim H on May 28, 2009

A couple of quick notes as I procrastinate finilizing Grant application and cell culture duties.

Some really cool news from International Stem Cells came out yesterday.  From their web site:

WEDNESDAY, MAY 27, 2009

International Stem Cell Corporation Reports Positive Pre-Clinical Trial Results From Human Corneal Epithelial Cells

International Stem Cell Corporation (OTCBB:ISCO), the first company to perfect a method of creating human “parthenogenetic” stem cells from unfertilized eggs, has received positive early results from animal trials designed to improve photorefractive keratectomy (PRK), a form of corrective laser eye surgery that offers an improved alternative to LASIK.

PRK is generally thought to be safer and produce better long-term results than LASIK, but has not been used as frequently because of patient discomfort following surgery and a longer healing time. By combining ISCO’s human corneal cells with a proprietary surgical device developed by Paul H. Chen, M.D., who is conducting the trials, ISCO and Dr. Chen believe that cellular enhanced PRK can replace LASIK for many of the hundreds of thousands of patients who now use LASIK.

The first stage animal trials just completed demonstrated that ISCO’s corneal cells manufactured by ISCO’s subsidiary, Lifeline Cell Technology, encouraged corneal-defect healing in the animals. The trials are the first step toward gaining Food and Drug Administration (FDA) approval to test the efficacy of using ISCO’s cells to improve healing after corneal surgery, and could result in the first FDA approved use of human cells produced by ISCO.

Jeffrey Janus, President of ISCO and CEO of Lifeline, noted that “The cells used in these trials are derived from donated human tissue processed using proprietary techniques devised by ISCO’s subsidiary, Lifeline Cell Technology. However, ISCO’s parthenogenic stem cells can also produce human corneal cells. Corneal cells derived from ISCO’s parthenogenetic stem cells may provide a consistent and reliable source of corneal cells that could eliminate entirely the need for donated human tissues.”

This work is being done in collaboration with Dr. Chen, who has developed the cell transfer technology. Dr. Chen is an eye surgeon at North County Laser Eye Associates, and he is on staff at Scripps Memorial La Jolla and Scripps Encinitas Hospitals.

For more news and information on International Stem Cell Corporation please visit http://www.IRGnews.com/coi/ISCO where you can find the CEO’s video, a fact sheet on the company, investor presentations, and more

Maybe those of you who aren’t in the Biotech field don’t know how important it is to have “preclinical” data, which allows you to apply to the FDA for permission to run clinical trials. Your preclinical data had better be air tight and good.  Of course, the material was made by LifeLine in Walkersville, so it must be good. And for the sake of full disclosure and shameless self promotion, I am providing processed tissues for some other things that LifeLine is doing and I want them to do well.  Rumor has it they’ve installed additional, temporary space.  So all you people that I have telling to pay attention to little LLCT and ISCO, pay attention.

In other news, I was “tipped off” that a new RFP was posted on the SAIC-Frederick web site.  This is a pretty big one, but you’re going to need animal facilities. You can find the whole SOW and all the required documents  HERE, but this is the meat of it:

Solicitation No. S09-159  GLP Safety Testing of Vaccines Developed by Vaccine Research Center (VRC) Manufactured for Clinical Trial Use

Due date June 30, 2009

Perform GLP safety studies suitable for submission to the FDA for support of an IND application.

o Confirm AAALAC accreditation prior to initiating the study

o Work with the VRC to develop and finalize protocols. The VRC and the Subcontractor will sign off on the protocol and retain a copy

o Purchase and quarantine of suitable animals as specified in the protocol

o Housing of animals (1 animal per cage), test animals and control animals in separate rooms

o Administer injections of vaccine as directed in study protocol

o With VRC’s help, acquire and become trained to use Biojector and any other specialized injection devices

o Provide clinical evaluation and assess other measurements of health as specified in the protocol

o Euthanize animals and perform a gross necropsy in accordance with study protocol

o Collect blood and tissue from animals; send aliquot of blood to VRC for immune analysis and send tissues for other analysis as directed by VRC

o Run clinical chemistry and hematology tests as specified in protocol

o Run biodistribution studies as specified in protocol

o Analyze histopathology of preserved tissues as specified in the protocol

o Perform statistical analyses of test results and provide updated historical data for gender-matched unimmunized or placebo-controlled animals for comparison as specified by the protocol

o Audit test results

o As appropriate, investigate deviations of the protocol, procedures, or unexpected test results (e.g. moribund or found-dead animals) and report such investigations to VRC staff in a timely fashion.

o Provide unaudited interim, unaudited, and audited, signed final report as indicated in the protocol

• Interim clinical observations and measurements via email on a bi-weekly basis as indicated in the protocol. Interim (“unaudited”) report transmitted electronically to Project Coordinator and the VRC Project Lead (contact information listed below)

• Final report – One hard copy of this report can be sent to the VRC Project Lead and an electronic pdf version can be provided to Project Coordinator.

I hope they get as many interested parties as the last request, but haveing GLP animal facilities may make it tough.

Posted in Awards and recognition, Business, Expansion, Funding Available, Government Funded research, News, Public/Private Companies, Rants, Rumors, Stem Cells, Vaccines | Leave a Comment »

 
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