THURSDAY, March 17 — Cutting-edge gene therapy on Parkinson’s disease patients significantly improved the tremors, rigidity and other motor skill problems that are hallmarks of the illness, a small new study reports.

The phase 2 study enrolled 45 patients with moderate to advanced Parkinson’s disease, with half randomly assigned to receive the gene therapy and half assigned to undergo a “sham” surgery, a mock procedure designed to mimic the experimental approach.

Of the 22 patients who were infused directly into the brain with the glutamic acid decarboxylase (GAD) gene — which prompts the production of a chemical known as GABA that improves motor control — half experienced “clinically meaningful improvements” of their symptoms within six months of surgery, the study authors said.

Although several open-label trials on gene therapy have shown promise in treating neurologic disease, the researchers noted that this is the first of its type to be confirmed in a follow-up randomized double-blind trial, a study in which neither the investigators nor the patients knew which patients were receiving the real or sham treatment.

“It’s a completely novel therapy — unlike anything that’s currently offered,” said co-investigator Dr. Andrew Feigin, an associate investigator at the Center for Neurosciences at Feinstein Institute for Medical Research in Manhasset, N.Y.

“I think we expected to see this effect, but you never know,” Feigin added. “I was gratified.”

The study is published online March 17 in The Lancet Neurology.

Parkinson’s disease affects about one million Americans, most of them over age 50, and is the second most common neurodegenerative disease after Alzheimer’s, according to the National Parkinson Foundation.

In addition to confirming results of earlier clinical trials, the treatment didn’t have any serious adverse effects on the participants, who ranged in age from 30 to 75, according to the study. the most common mild side-effects related to the treatment were headache (affecting seven of the patients in the infusion group versus two in the sham group) and nausea (six versus two).

Phase 3 trials must be conducted before the U.S. Food and Drug Administration decides whether to approve the treatment for general use.

The therapy, which was done with local anesthesia, used a harmless, inactive virus to deliver the GAD gene into each patient’s subthalamic nucleus, a key brain region involving motor function. the gene instructs cells to begin making GABA neurotransmitters to re-establish the normal chemical balance that becomes dysfunctional as the disease progresses.

At the six-month mark, patients in the gene therapy group who had been off their medications for 12 hours showed an average 23.1 percent improvement on a scale used to assess motor function in Parkinson’s patients, while placebo patients had a 12.7 percent improvement.

“For the first time, we’re one step closer to a gene therapy for any neurological disease, because we passed this hurdle,” said study co-author Dr. Michael Kaplitt, vice chairman for research in the department of neurological surgery at Weill Cornell Medical College in New York City.

“I think we’re closer than we’ve ever been to be able to realistically tell patients . . . they can get this done,” said Kaplitt, also a co-founder of Neurologix Inc., the Fort Lee, N.J. company that is developing the GAD therapy and that funded the current study. (Several other researchers also have financial ties to Neurologix and/or a patent related to the GAD product.)

Another surgical procedure, known as deep brain stimulation, which permanently implants a nerve control device in the brain, has helped control Parkinson’s symptoms in thousands of patients over the last decade. Deep brain stimulation is apparently associated with twice the rate of clinical improvement as the gene therapy, according to background information in the study.

Kaplitt and Feigin said it would be difficult to compare the highly effective deep brain stimulation to gene therapy just yet, but that each procedure offers different benefits.

“In practice . . . there are lots of factors,” Feigin said, noting that costs for both may be similar. “Some patients might not want hardware in their brain, or others want tried and true methods. some want state-of-the-art. so a lot will be determined by the patient.”

Dr. Michael S. Okun, national medical director of the National Parkinson Foundation, praised the study, saying it opens the door to “the hope for better symptomatic therapies in Parkinson’s disease, though patients should clearly understand their limitations.”

Okun added, “The gene therapy approach is clever and different. this is an important study, particularly in terms of safety. it will be important to follow these patients longer to look for delayed benefits and potentially delayed risks.”

More information

The U.S. National Institute of Neurological Disorders and Stroke has more on Parkinson’s disease.

Good Samaritan Food Pantry

Shepherd’s House Ministries, Inc., located at 5739 Stewart Street in Milton, will have their food distribution on Saturday, March 19. Sign up begins at 7 a.m. Distribution is from 11 a.m. to 12 p.m. (cut off). for more information call 850)530-4011.

Western Gate Chapter Florida Trail Association Monthly Meetup

There will be a monthly meetup on Thursday, March 17, at 6:30 p.m. at the first Christian Church, corner of Langley and Goodrich in Pensacola. this is a monthly chapter meeting to discuss past activities and report on new activities coming up with a program about hiking or the outdoors. There will also be refreshments. this meeting is free to members and the public. for more information call (850) 725-4408 or 366-2328.

Early Learning Coalition to meet

The Early Learning Coalition of Santa Rosa County will hold board and committee meetings on Thursday, March 17. the Finance Committee will meet at 9 a.m. and the Executive Committee will meet at 9:30 a.m. followed by the full board meeting at 10 a.m. the meetings will be held in the Conference Room of the Early Learning Coalition Office, 6555 Caroline Street (located in the back of the parking lot between Domino’s Pizza and Papa John’s Pizza). these meetings are open to the public.

Colon Health is topic at Sacred Heart Seniors Seminar

Sacred Heart Hospital’s SENIORSpirit! program will present a free seminar on colon health on Wednesday, March 23 from 9:30 to 11 a.m. in the Dudley Greenhut Auditorium on Sacred Heart’s main campus.

Dr. James Smith, a board certified gastroenterologist with Gastroenterology Associates, will present the program covering the most common signs and symptoms of common colon problems, including colon cancer, as well as prevention tips. for more information call (850) 416-1620.

Columbus Replica Ships, Pinta and Nina land in Ft. Walton Beach

On Thursday, March 24, the Pinta and the Nina will be in Ft. Walton beach, docked at the legendary Marine, 1198 Miracle Strip Parkway, Brooks Bridge, until their departure Monday, March 28. While in port the general public is invited to visit the ship for a walk-aboard guided tour. Admission charges are $8 for adults, $7 for seniors, and $6 for students age 5 to 16. Children under 4 are free. Ships are open every day from 9 a.m. to 5 p.m. no reservations necessary. for guided tours, call 1-787-672-2152 (minimum of 15).

Oh my Aching back! Surgery or not?

Back pain is one of the most common reasons for missed work, and the second most common reason for visits to the doctor’s office. back pain is not a diagnosis: it’s a symptom of an underlying condition. Experts from the Andrews Institute Spine Center are offering a Free Seminar on Friday, March 25 at t he Andrews Institute Athletic Performance  & Research Pavilion, 1020 Gulf Breeze Parkway, classrooms A & B. Registration is 11:30 a.m. and the program begins at noon. Register by calling (850) 916-8585.

US 90 Corridor Public Workshop Invitation

You are invited to attend the second public workshop on Tuesday, March 22 anytime between 5:30 – 7:30 p.m. at the Santa Rosa County Media Room, 6051 Old Bagdad Highway, Milton. Purpose is to provide an overview of the comments received from the first public workshop, present the recommended improvements and solicit additional input. any questions, please contact Brian Youpatoff (TPO Staff) at (850) 332-7976, Extension 224 or . you may also contact Wiley Page (PBS&J-General Planning Consultant for the project) at (904) 363-6100, ext 8461 for additional information.

Local graduates University of Wisconsin-Whitewater

Kristin Leigh Winterhalter of Pace graduated from the University of Wisconsin-Whitewater, Wisconsin in December 2010 with an MBA in Business Administration. Congratulations!

City of Milton meeting

City of Milton Sports Advisory Board will meet on Thursday, March 24 at 6 p.m. in the Meeting Room “C” of the Milton Community Center, 5629 Byrom Street.

Bagdad Elementary’s Spring Fling

The community is invited to Bagdad Elementary’s Spring Fling on Saturday, March 26 from 10 a.m. to 1 p.m. at Bagdad Recreational Facility. There will be a bouncy house and slide, food, games and prizes as well as a silent auction on themed baskets. for further information, call 981-0193.

Pace Community Health fair

The 5th annual Sacred Heart Medical Park at Pace Community Health fair will be held on Saturday, March 26 at 9 a.m. at the Sacred Heart Medical Park at Pace building on Highway 90, across from Oops Alley. the public is invited to this fun-filled family event featuring health screenings, health information and advice, booths from area businesses, great door prizes and more. Screenings available will be blood pressure, blood-oxygen levels, body fat, grip testing, and stroke risk assessments. Attendees will be treated to lunch, as well as the chance to win some great door prizes. for more information, call Tim Gilbert at (850) 698-2202.

Green-Up Ready to Kick off Spring

Green-Up Santa Rosa will be kicking off the spring season with a wide variety of trees, shrubs, flowers and hanging baskets available. Starting Friday, March 18, the annual spring sale begins. Tea olives, lorapetalum, bridal wreath, Japanese magnolias and more are in full bloom. the popular florist quality ferns are here, as well as more hanging baskets of flowering plants. Peach, pear and plum trees are ready to be put in your landscape. Trees and shrubs of all varieties are also available. Green-Up is a program of the Santa Rosa clean Community system. All proceeds from sales are put into public plantings and environmental programs. you may contact the nursery at 623-1930 and learn more about the clean Community system at srclean.org.

The SBDC to present workshops

The Small Business Development Center at the University of West Florida (401 E. Chase Street, Suite 100), is presenting “Record Keeping in Small Business: A Foundation for Business Continuity Planning” in four morning sessions on Tuesdays/Thursdays, Mar 22, 24, 29, 31, 2011 from 9:00 a.m. – Noon. during this 4-part workshop series, attendees will learn how to keep records, develop financial statements, asset depreciation schedules, understand tax records and plan for business continuity. Attendance fee for all four sessions is $55 for the public and free for students and faculty members of the University of West Florida who present a Nautilus card. Attendees are asked to bring a calculator.  since our funding agency requires a minimum number of attendees, we cancel workshops that don’t meet these requirements.  Pre-registration is strongly recommended. for further information, or to register, call:  (850-595-0063) or log onto our website at:  sbdc.uwf.edu and click on “training”.

 also, the Small Business Development Center at the University of West Florida (401 E. Chase Street, Suite 100, Pensacola) is presenting “Starting a Business” on Wednesday morning, March 23, 2011 from 9:00 a.m. to Noon.  Attendees will learn about taxation, financing, insurance, and legal forms of business. Attendance fee is $35 for the public and free for students and faculty members of the University of West Florida who present a Nautilus card. since our funding agency requires a minimum number of attendees, we cancel workshops that don’t meet these requirements. Pre-registration is strongly recommended.  call to register. (850-595-0063).