Gene Therapy in Ophthalmology Update 14 Early Positive Results in Ongoing Gene Therapy Wet AMD and Stargardt’s Disease Studies

Last week, Oxford BioMedica and its partner Sanofi announced positive results in their ongoing gene therapy clinical trials for wet AMD and Stargardt’s disease. In an interim review of their Phase I (RetinoStat) and Phase I/IIa (StarGen) trials, the Data Safetly Monitoring Board (DSMB), an independent panel of specialists in the fields of ophthalmology, virology and vectorology, gave the go ahead to proceed to a final patient cohort in the Phase I study in the case of the RetinoStat trial, and to a third patient cohort in the Phase I/IIa study of the StarGen trial.

The companies announced the following:

DSMB highlights of ongoing RetinoStat Phase I study:

● Nine patients treated to date (n=3 at each of dose levels 1, 2 and 3)

● No serious adverse events related to RetinoStat or its method of administration

● Long-term safety profile now up to 18 months post-treatment (dose level 1)

● Successful retinal transduction, as shown by substantial increase in expression and secretion of endostatin and angiostatin proteins measured in the anterior chamber of the eye following a single administration of RetinoStat. So far, expression is sustained for up to 12 months post-treatment at dose level 1 (n=3) and up to six months post-treatment at dose level 2 (n=3) (The extent of the followup to date on dose level 2. Longer term results are expected to be achieved.)

● DSMB support received to proceed to final patient cohort (n=9, confirmatory dose level)

The RetinoStat open label, dose escalation Phase I study will enrol 18 patients total with"wet" AMD and will evaluate three dose levels to assess safety and aspects of ocular physiology.

The study is led by Professor Peter Campochiaro at the Wilmer Eye Institute at Johns Hopkins, Baltimore and Oxford BioMedica has now opened a second clinical site at the Oregon Health and Science University, Portland with Dr Andy Lauer as principal investigator.

Further results from this study are expected in Q4 2012.

On the basis of pre-clinical data, it is anticipated that RetinoStat may require only a single administration which would give the product a significant advantage in the market over currently available treatments that often require frequent, repeated administration.

DSMB highlights of ongoing StarGen Phase I/IIa study:

● Eight patients treated at dose level 1 to date (n=4 severe level of disease, n=4 less severe)

● No serious adverse events related to StarGen or its method of administration

● Long-term safety profile now up to 12 months post-treatment (dose level 1)

● DSMB support received to proceed to third patient cohort (n=4, dose level 2)

The StarGen open label, dose escalation Phase I/IIa study will enrol up to 28 patients and will

evaluate three dose levels for safety, tolerability and aspects of biological activity.

In the US, the study is led by Professor David Wilson at the Oregon Health and Science University, Portland, Oregon. In France, Professor Jose-Alain Sahel leads the study at Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris.

StarGen has received European and US Orphan Drug Designation which brings development, regulatory and commercial benefits.

Further results from this study are expected in Q4 2012.

As noted above for the RetinoStat treatment, on the basis of pre-clinical data, it is anticipated that a single application of StarGen to the retina could potentially either provide long-term or permanent correction. There are currently no approved treatments available for Stargardt disease.

John Dawson, Chief Executive Officer of Oxford BioMedica, said:"The continued progress of our ophthalmology portfolio, supported by another positive DSMB review, is encouraging - particularly given that early RetinoStat data demonstrate sustained therapeutic protein expression in the eye following a single administration. The favourable safety profile of our novel ocular gene therapies further supports the wider LentiVector platform safety package with over 33 patients treated to date across the ocular and Parkinson's disease programmes."

The Many Benefits Of Positive Thinking Seminars

By Sharon Weeks

Being an employer, you understand that your employees are your front liners. They are the ones tasked to get your operations running smooth and efficient all the time. Keeping them happy means keeping them productive and efficient. This is why you always strive towards introducing programs that might make it possible for them to be happier and more optimistic employees.

When people are unhappy, they tend to be down and less active. Most employees tend to be less enthusiastic on what they do when all they feel are negative vibes off of what they are doing. This is the reason that positive thinking seminars would be excellent avenues to develop the right and healthy attitude that employees should harbor when they are at home.

Every employer needs to understand the importance of getting their employees to have the right mindset as far as their work and their work responsibilities go. It is a good thing that there are seminars that they can be exposed to that should help inculcate such an ideal state of mind when it comes to facing the challenges they have to meet at work. Thus, they perform better and more efficiently.

See if there is a way for you to get your employees exposed to programs that are going to help promote positivity and optimism in the workplace. The last thing you want are a bunch of Debbie Downer's at work. A bad mood can literally influence the rest of the people in the floor. If you have people beaming with such positive attitude working for you, you can can only expect good things from them.

See if there are people that you can enlist the help of to conduct these programs too. You would prefer if you get your employees involved in empowering programs like these. People sometimes need to be reminded of the things that they should do when it comes to handling the tasks they must perform at work. Being able to get that positive outlook when meeting job demands will allow them to be more productive.

Take a good look at the program that they are offering too. You need to make sure that they're offering something comprehensive that will really cover those things that you want to be covered as far as prepping up your employees goes. You need to remember that there are various elements that you might want to be include in the program to make sure that it is indeed going to be most beneficial to your employees.

Plan the way the training is going to be disseminated too. A good way of doing this is to ensure that the schedule is properly set in such a way that there are still going to be people that will be in the production floor. You cannot just go ahead and pull everybody out of the operations floor to attend the program. You will need to get the training done by batches.

Find out how much they are going to charge you as fare as fees go too. Organizers will need your support to ensure that they can get their presentations done right. You need to make sure that they will charge the right fees too. Proper financial support is going to play a crucial role towards ensuring that the rest of the program is going to be properly presented to you.

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How To Find Good Positive Thinking Coach

By Della Monroe

Many people have their own struggles to face. Problem is common to anyone who is breathing. Whatever status you might have, you will still encounter various types of problems. It is how you deal with it that counts. Many individuals might not have anything in common. But because of these problems, it is easier to think about all people are the same.

Some people were able to bounce back from a big hurdle and live normally. These are the ones which are naturally resilient and are unfazed by various problems. But others were suffering too much that they were not able to carry the burden. Because of this, they fall into the state of depression and suffer from various disorders that could affect them negatively. In these cases, a positive thinking coach might be necessary.

They are the people who will help you get back to your positive side. Most of their therapies emphasize on staying positive. They could be a counselor or they can sometimes be called therapists. But there are others who could really be very drawn to the negative things and do not care about their health that it becomes hard for them to become better. Because of their help, the worse can easily be prevented.

Behavioral conditions could easily become the downfall of someone since it alters their behavior. This means that their reaction to things and how they behave would be geared towards the negative side of the spectrum. Getting back on their feet would not be easy. But it would be possible with the help of the experts and their guidance.

If they were already cleared and you can see that patients have retained their old behavior back, it might still be necessary for them to report to counseling from time to time. There are always things which would remind them of the past. Aside from that, simple problems could easily bring back their defenses or weaknesses. To ensure that they do not have any relapse, it might be best to always have them report to the clinic on a regular schedule.

Those who are experiencing behavioral conditions are not the only ones who could avail of this service. There are also normal people who have been going to coaches in order for them to easily improve their behavior. A means for developing your attitude could lead to success and help you avoid problems in the future.

Deciding to go for a coach can be very beneficial for you. But for each session to be positive and to have any meaning, it is necessary that you choose the right person for this. Only then can you see the positive effects this has on you. The payments you are spending would not have to go to waste.

Referring in their reputation can be a good thing since it would be a sure indication of how good their service is. This can be considered as your calling card when it comes their services. The better the reputation you have the more clients you also have. Through referring to the testimonies of others, it might be easier for you to decide.

You might want to review their credentials beforehand. Always know whether they are operating legally or not. Those who have clean business would surely provide you with documents and proofs such as permits. Some even have their own license and certificates to show that they could really provide you with the needed services.

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