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FDA response for ACT anticipated on January 31 (NASDAQ:ACTC)

By John McCalister on 01/30/2010 – 2:51 pm PST8 Comments

On November 19, 2009, Advanced Cell Technology, Inc. (NASDAQ: ACTC.OB), which is a biotechnology company that uses cloning techniques to develop a number of life-saving drugs, disclosed that the company has sent an Investigational New Drug (IND) Application to the Food and Drug Administration (FDA). The objective of the IND Application is seeking the approval of the FDA to start a Phase I/II study at multiple centers. The study would involve the use of retinal cells, which have been developed from the stem cells of the embryo, for the treatment of patients suffering Stargardt’s Macular Dystrophy (SMD). On January 8, 2010, the company again announced that the FDA has put it on “clinical hold”. This means the FDA is soon going to send Advanced Cell Technology a response to the latter’s submitted IND application.

Degenerative diseases of the eye part – the retina – are the most common diseases responsible for causing blindness. In addition, there is no way to restore the lost vision. More than 10 million people in the US alone suffer from degenerative disease of the photoreceptor – that is, the retina. Apart from Age-Related Macular Degeneration (AMD), Stargardt’s Macular Dystropy is the next common degenerative disease. It causes blindness in young people. For treating this disease, Advanced Cell Technology has developed a unique technique. Through cloning, the company was able to derive cells found in the retina – called collectively, the retinal pigment epithelium (RPE) – from stem cells.  These cells would help the photoreceptors for providing vision. In the onset of Stagardt’s Macular Dysrophy, the RPE cells die. This causes blindness.

Before the development of the RPE cells through cloning techniques by Advanced Cell Technology and its partners, there was no cure for this serious eye disorder. The ACT has carried out many studies to show that the RPE cells could cure blindness in animals. For instance the Royal College of Surgeon (RCS) rat model found out that RPE cells could achieve a staggering success rate of 100% in restoring lost vision. In addition, the study found out that there no side effects were associated with such technique.

Dr. Robert Lanza, who is the Chief Scientific Officer of Advanced Cell Technologies, said:

“It has been over a decade since human embryonic stem cells were first discovered. The field desperately needs a big clinical success. After years of research and political debate, we’re finally on the verge of showing the potential clinical value of embryonic stem cell research. Our research clearly shows that stem cell-derived retinal cells can rescue visual function in animals that otherwise would have gone.”

The submission of the Investigational New Drug application to the FDA represents a crucial point in the development of a substantial cure for Stargardt’s Macular Dystropy. William M. Caldwell IV, who is the Chief Executive Officer and also the Chairman of the ACT said:

“The filing of this IND places Advanced Cell Technology in position to help lead the industry in validating the stem cell platform. Over the past year, we have taken important steps to advance our RPE program while overcoming significant financial challenges. Advanced Cell today is uniquely positioned within the regenerative medicine industry; as it has the technology, a renowned scientific and development team and access to capital to become one of the first companies to make the use of an embryonic stem cell derived therapy a reality in treating a major unmet medical need.”

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  • Kevin says:

    100% success in rats with no side effects? If the FDA fails to allow them to go forward it will be politics pure and simple. Let’s hope we have moved past that nonsense toward a future of scientific progress and hope for humanity. Go ACT, go!

  • Linda Sue Johnson says:

    January 31, 2010? The FDA works on Sundays?????

  • Lisa says:

    Medical research in labs all over the world never stop working, even on Sundays.

  • mike says:

    there might be some religious consideration

  • Jason says:

    Another note that many don’t know - Advanced Cell Technology uses a patented method that DOES NOT HARM the embryo. Similar method used all the time in in-vitro fertilization clinics to test for a healthy embryo pre-implantation.

  • dandaman53 says:

    Let’s hope that science will be allowed to move forward after 8 years of living in the dark ages. The US has been lagging behind many countries in the world on stem cell research. This is a disease that affects mainly children, there is currently no cure. FDA, give these kids some hope!

  • Peter says:

    Well? Has any word come out? I wonder how long such a trail might take, or for that matter what the next steps would be and how long they might take (trusting that the trail work be successful)…

  • Colorwonder says:

    I dont think they expect a definitive decision until mid year.