Great Weather Predicted For This Weekends “Give A Gift Of Breath” Motorcycle Ride

Motorcycle (Maurice CC FLIKR)Motorcycle Riders Cruise Through Central New Hampshire For A Good Cause 

The Second Wind Foundation for Pulmonary Fibrosis Hosts annual “Give A Gift Of Breath” ride to help raise money for patient support and research.

(Hooksett,NH) This Saturday is expected to be a perfect September day in New Hampshire, and riders from all across the region are expected to take part in the “Give A Gift Of Breath” motorcycle ride to benefit The Second Wind Foundation for Pulmonary Fibrosis.

“Saturday is predicted to be a perfect day for a motorcycle ride,” said Ron Geoffroy, President of the Second Wind Foundation for Pulmonary Fibrosis.   “With the addition of live music by the Rik-Sha Band, and food provided by the Puritan Backroom, this could be our biggest ride to date.”

Pulmonary Fibrosis is a rare lung disease that creates scar tissue inside the lungs, making it harder and harder to breathe.   Pulmonary Fibrosis currently effects more than 500,000 people in the US.

The annual ride brings in much needed donations that are used to fund ongoing research, like the “Pirfenidone” drug trials.  The donations also go to our new “Breathe Easy” program that provides monetary support for families who are suffering with Pulmonary Fibrosis.  The Second Wind Foundation provides qualifying families with gas cards to ease the cost of multiple visits to pulmonary specialists.

The ride kicks off from the Plumbers and Pipefitters Hall, 161 Londonderry Turnpike, Hooksett, NH at 10:30 am.  The cost is $25 per motorcycle, and $10 per additional rider. Registration starts at 8 am.

After the two-hour scenic New Hampshire ride, feast on lunch provided by The Puritan Backroom, and enjoy live rockabilly-blues music from the Rik-Sha Band.  There will also be silent auctions and raffles for great prizes from local restaurants and shops.

“We look forward to seeing everyone Saturday morning for the Give A Gift of Breath motorcycle ride,” added Geoffroy.


Bikes and Riders



Rik-Sha Blues Band To Perform At Second Wind Motorcycle Ride, Volunteers Still Needed

The summer is slowly coming to a close and that means that the Second Wind Foundation’s annual motorcycle ride is fast approaching. If you have not signed up to take part in the “Gift of Breathe Ride,” click here to sign up.

We are pleased to announce that after this years ride, the Second Wind Foundation will be providing live music for you to enjoy while you feast on food from the Puritan Back Room.

 

Rik-shaw2

The Rik-Sha Band will be performing their own mix of rock and blues. They will entertain you with a mix of music from Hendrix, to CCR, to Neil Young and some they wrote themselves.

Rik-shaw1

We are also looking for people who would be interested in volunteering for the event. We will need people to help set up food, tables, register riders, etc. If you are interested in volunteering, email Ron, by clicking here.

We look forward to seeing you all there on September 13th!

Remember if you sign up before the end of August you can save $5.00 on your registration fee.

 

FDA Holds Public Meeting On Idiopathic Pulmonary Fibrosis Patient-Focused Drug Development

FDA LOGO
On September 26, 2014, FDA is conducting a public meeting on Idiopathic Pulmonary Fibrosis Patient-Focused Drug Development.

Date:                September 26, 2014

Time:               1:00 a.m. to 5:00 p.m.

Location:         FDA White Oak Campus

10903 New Hampshire Ave.

Building 31 Conference Center, The Great Room (Rm 1503)

Silver Spring, MD 20993

FDA is interested in obtaining patient input on symptoms and daily impacts that matter most to patients (topic 1), and current available approaches to treat idiopathic pulmonary fibrosis (topic 2). The questions for discussion on these topics are below.

For each of these topics, a panel of patients and patient representatives/advocates will present comments to begin the dialogue and will be followed by a facilitated discussion inviting comments from all patients and patient representatives in the audience.

If you are interested in providing comments as part of the initial panel discussion, indicate so during the registration process. Panelists will be confirmed prior to the meeting.

There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting.

Webcast participants will also have an opportunity to provide input through webcast comments.

For more information, refer to the FDA meeting website at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm395774.htm

Questions for Discussion

Topic 1: Disease signs, symptoms and daily impacts that matter most to patients

1)    Of all the symptoms that you experience because of the condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include shortness of breath, cough, fatigue, etc.)

2)    Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include household chorse, walking up the stairs, etc.)

a)    How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?

3)    How has your condition and its symptoms changed over time?

Topic 2: Patient perspectives on current approaches to treating idiopathic pulmonary fibrosis

1)    What are you currenty doing to help treat the condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as diet modification.)

a) How well does your current treatment regimen treat the most significant symptoms of your diease?

2)    What are the most significant downsides to your current treatments and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, etc.)

3)    Because there is no complete cure for your condition, what specific things would you look for in an ideal treatment for your condition?

SIGN UP

Click here to sign up to attend in person or via webcast

New Inhaled “Pirfenidone” Treatment For PF Begins Trials In Early 2015

InhalerGenoa Pharmaceuticals Receives Orphan-Drug Designation for Pirfenidone in the Inhaled Treatment of Idiopathic Pulmonary Fibrosis (IPF)

SAN DIEGO, Aug. 5, 2014 /PRNewswire/ — Genoa Pharmaceuticals, the leader in inhaled medicines for pulmonary fibrosis, today announced the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to Genoa for the use of pirfenidone in their lead program – inhaled GP-101 for the treatment of IPF.

“Acquiring orphan status marks an important regulatory milestone in GP-101’s life cycle to treat people with this devastating disease,” said Mark Surber, Ph.D., Genoa’s President and Chief Executive Officer. “We are pleased to continue the development of inhaled GP-101, with clinical trials beginning in early 2015.”

Oral pirfenidone (Esbriet®) has shown promise to slow IPF disease progression. Unfortunately, a very large oral dose is required to achieve efficacious lung levels. Despite being established at the upper safety threshold (801 mg TID), the resulting oral-delivered lung dose is too low for optimal effect. Moreover, gastrointestinal exposure and large-associated blood levels remain poorly tolerated. For these reasons oral-dose escalation for optimal IPF efficacy is not possible. Complicating matters, dose-absorbing food, first-pass metabolism, and safety-driven dose-reduction and stoppage protocols further reduce lung dose and interrupt maintenance therapy.

To address oral shortcomings and maximize IPF efficacy, Genoa has reformulated pirfenidone for aerosol formation and inhaled, direct-lung delivery (GP-101).  By this approach, ~160-fold less inhaled pirfenidone is predicted to deliver Esbriet-equivalent IPF efficacy (5 mg vs. 801 mg). With such a small inhaled dose, remaining safety and tolerability concerns may be eliminated, enabling improved patient compliance and an increased inhaled dose for superior IPF efficacy. In addition to serving as an improved-effect Esbriet replacement, a safe and well-tolerated inhaled product is expected to enable desired, but otherwise poorly-tolerated combination regimens (e.g., with Boehringer Ingelheim’s Nintedanib).

About Orphan Drug Designation

Orphan drug designation is a status assigned to a medicine intended for use in rare diseases. In the U.S., the Orphan Drug Designation program provides orphan status to medicines intended for the safe and effective treatment or prevention of rare diseases that affect fewer than 200,000 people. In the E.U., a medicine must meet similar criteria, affecting up to five in 10,000 people. Orphan designation for inhaled GP-101 will be pursued in the E.U. with clinical data.  Orphan status provides sponsors with development and commercial incentives, including 7 and 10 years market exclusivity for these two regions, respectively.

About IPF

IPF is a fatal lung disease caused by both genetic and environmental factors resulting in progressive lung scarring and death due to respiratory failure and/or co-morbidities.  Characterized by a dry cough, shortness of breath and decreased exercise capacity, this disease exhibits a post-diagnosis survival period of ~2-5 years, annually killing more people than breast cancer. As fibrosis is at present irreversible, an efficacious product will provide a well-tolerated stand-alone or combination maintenance therapy that protects healthy lung tissue against invading fibrosis or meaningfully slows disease progression.

About Genoa Pharmaceuticals

Genoa Pharmaceuticals, Inc. is committed to developing improved therapies for the treatment of IPF. Based in San Diego, Genoa’s lead program, GP-101 (aerosol pirfenidone) plans to enter clinical trials in early 2015. Learn more atwww.genoapharma.com

POEM: A Caregiver’s Treasure Book

image by Christooher FLICKR CC

image by Christopher FLICKR CC

A Caregiver’s Treasure Book
By Cyndie Goins Hoelscher

Caregiver,
in case someone hasn’t mentioned it,
you are a treasure – radiant, precious and rare.

You care,
bestowing your gifts in a time
when the world may not seem so bright or pretty.

You are treasured
as highly as the diamonds, rubies, and sapphires
precious gems in this world.

These jewels,
rarely recognized in their natural state,
are cut, faceted and polished,
until they sparkle for the whole world to admire.

Like these stones, caregivers shine.
And when the world may not seem so pretty,
remember this gift – a treasure box
to keep in your secret place,
so you will be reminded time and time again
of how priceless you truly are.

Posted by Karen Casey – Caregivers are truly special!

Pirfenidone, A Drug Treatment For People With PF Enters Third Stage Of Trials

Below is a new article on Pirfenidone moving to the next stage of trials.  Full article here.

A Phase 3 Trial of Pirfenidone in Patients
with Idiopathic Pulmonary Fibrosis

BACKGROUND

In two of three phase 3 trials, pirfenidone, an oral antifibrotic therapy, reduced disease progression, as measured by the decline in forced vital capacity (FVC) or vital capacity, in patients with idiopathic pulmonary fibrosis; in the third trial, this end point was not achieved. We sought to confirm the beneficial effect of pirfenidone on disease progression in such patients.

METHODS

In this phase 3 study, we randomly assigned 555 patients with idiopathic pulmonary fibrosis to receive either oral pirfenidone (2403 mg per day) or placebo for 52 weeks. The primary end point was the change in FVC or death at week 52. Secondary end points were the 6-minute walk distance, progression-free survival, dyspnea, and death from any cause or from idiopathic pulmonary fibrosis.

RESULTS

In the pirfenidone group, as compared with the placebo group, there was a relative reduction of 47.9% in the proportion of patients who had an absolute decline of 10 percentage points or more in the percentage of the predicted FVC or who died; there was also a relative increase of 132.5% in the proportion of patients with no decline in FVC (P<0.001). Pirfenidone reduced the decline in the 6-minute walk distance (P=0.04) and improved progression-free survival (P<0.001). There was no significant between-group difference in dyspnea scores (P=0.16) or in rates of death from any cause (P=0.10) or from idiopathic pulmonary fibrosis (P=0.23). However, in a prespecified pooled analysis incorporating results from two previous phase 3 trials, the between-group difference favoring pirfenidone was significant for death from any cause (P=0.01) and from idiopathic pulmonary fibrosis (P=0.006). Gastrointestinal and skin-related adverse events were more common in the pirfenidone group than in the placebo group but rarely led to treatment discontinuation.

CONCLUSIONS

Pirfenidone, as compared with placebo, reduced disease progression, as reflected by lung function, exercise tolerance, and progression-free survival, in patients with idiopathic pulmonary fibrosis. Treatment was associated with an acceptable side-effect profile and fewer deaths. (Funded by InterMune; ASCEND ClinicalTrials.gov number,NCT01366209.)

Read the full story here

Congresswoman Annie Kuster (NH-02) Helps Introduce Bill to Support Family Caregivers

Representative Kuster talks of her families struggle with Alzheimer’s however this bill would apply to those who are caring for people suffering from Pulmonary Fibrosis as well.  

Young Caregiver (wiki) WASHINGTON, DC – On the heels of Alzheimer’s awareness month, Congresswoman Annie Kuster (NH-02) has helped introduced legislation that would provide support for individuals acting as caregivers for ill family members or other chronically dependent individuals. The Social Security Caregiver Credit Act would increase Social Security benefits for qualifying caregivers who spend more than 80 hours per month providing care to their loved ones.

Caregivers are often overlooked in the discussion of how to address and prevent long-term chronic illnesses like Alzheimer’s disease. However, many caregivers are forced to miss work or take unpaid leave, which places a severe financial strain on their families. Kuster has long-supported efforts and programs to help ease this burden on caregivers.

“As someone who served as a caregiver for my mother when she suffered from Alzheimer’s disease, I understand firsthand the challenges caregivers face when a loved one or dependent becomes chronically ill. I was lucky enough to also have the support of my family, but many individuals face these challenges alone, and the financial burden of missed work can be truly crippling,” said Congresswoman Kuster. “We must ensure that every caregiver has the support and resources they need to provide care for their ill loved ones and fellow Granite Staters who need the help, and that’s why I was proud to help introduce the Social Security Caregiver Credit Act, which will provide a crucial credit to long-term caregivers.”

The Social Security Caregiver Credit Act would be particularly beneficial to women, who make up 66 percent of unpaid caregivers and who are more likely to care for patients suffering from Alzheimer’s or dementia. Providing caregivers with this credit would help recognize their positive societal contribution, and would improve their retirement security by boosting their Social Security benefits.

Congresswoman Annie Kuster’s mother was first diagnosed with Alzheimer’s in 2001, and Kuster spent the next four years caring for her alongside her family. Kuster and her mother co-wrote a book entitled, “The Last Dance: Facing Alzheimer’s with Love and Laughter” to detail their experience with Alzheimer’s. Kuster continues to advocate in Congress for increased research funding and programs to support Alzheimer’s patients and their caregivers.

The Second Wind Foundation For Pulmonary Fibrosis Proudly Announces The “Breathe Easy” Program To Help Families Suffering From Pulmonary Fibrosis

For Immediate Release

The Second Wind Foundation For Pulmonary Fibrosis Proudly Announces The “Breathe Easy” Program To Help Families Suffering From Pulmonary Fibrosis 

The Second Wind Foundation to provide gas cards to families who are suffering from Pulmonary Fibrosis.

Filling Gas Tank (KOMUnews CC Flikr)Auburn, NH – The Second Wind Foundation for Pulmonary Fibrosis proudly announces the start of a new program designed to help families who are suffering from Pulmonary Fibrosis.

Pulmonary Fibrosis is a rare lung disease that creates scar tissue inside the lungs, making it harder and harder to breathe.   Pulmonary Fibrosis currently effects more than 500,000 people in the US.  After being diagnosed with Pulmonary Fibrosis, patients must meet with their doctors regularly to monitor their condition.  The increase in doctor visits, home healthcare, and oxygen tanks put a significant financial strain on patients and their families.

Ron and Marylou Geoffroy started the Second Wind Foundation for Pulmonary Fibrosis, after Marylou was diagnosed with Pulmonary Fibrosis.

“As Marylou’s condition deteriorated, we were traveling to Boston for doctors appointments a few times a month,” said Ron Geoffroy President of the Second Wind Foundation for Pulmonary Fibrosis. “This is exactly why we started the ‘Breathe Easy’ program, to give some monetary support to families suffering from Pulmonary Fibrosis.”

To help families deal with the financial strains that a chronic disease can have, the Second Wind Foundation for Pulmonary Fibrosis created the Breathe Easy program to provide $50 gas cards to qualified recipients.

The Breathe Easy program is open to anyone who suffers from Pulmonary Fibrosis or for those who are caring for someone with PF.  The Breathe Easy application can be downloaded at http://secondwindforpf.com/breathe-easy-program/.

Right now there is no cure for Pulmonary Fibrosis, and thanks to donations from the Second Wind Foundation for Pulmonary Fibrosis, new research is helping to find a cure.

To help raise money for this new program the Second Wind Foundation is hosting a charity motorcycle ride this September. The “Give A Gift Of Breath” motorcycle ride will be held on September 13th 2014 and begins at the Plumbers and Pipefitters Hall, 161 Londonderry Turnpike, Hooksett, NH.

Enjoy a scenic ride through the tree-lined roads of central New Hampshire, and then enjoy some great food courtesy of the Puritan Back Room.

Registration for the ride begins at 8:00 am with kickstands up at 10:30 a.m.  The cost is only $25 per bike and $10 for additional riders.

“The Give a Gift of Breath motorcycle ride is one of our biggest annual fundraisers for the Second Wind Foundation,” said Geoffroy. “To encourage people to sign up early for the ride, we are offering a $5 discount if you register now.”

For more information about the Second Wind Foundation for Pulmonary Fibrosis, and to register for our upcoming ride, go to http://secondwindforpf.com/.

The Second Wind Foundation For Pulmonary Fibrosis Announces “Breathe Easy” Program To Support Families With PF

A program of Support for Families
From The Second Wind Foundation for Pulmonary Fibrosis

The program is designed to provide support for families affected by Pulmonary Fibrosis.  It’s understood that the program is not all encompassing, however with additional resources the organization can continue to expand the program to include other aspects of assistance.

As an introduction to the program, initially we will provide a $50 gas gift card to each viable applicant that requests assistance through the application process.  Applications will be submitted to a 3-person subcommittee who will review all applications for their viability.

The following will be, but not limited to,  items of information that will be necessary for the subcommittee to approve patients for the program.  This information is to be completed by the applicant or caregiver.  It may be necessary for the Second Wind Foundation to contact applicants to request additional information.  Submittal of the application is approval for the organization to contact you.

Click here to download an application

More information on the program can be found here, or by clicking the Breathe Easy tab in the top menu bar.

Carol’s Story Of Living With Pulmonary Fibrosis: It All Started With Trouble Breathing

Quilting (Image by Gina Pina)

One of Carol’s favorite activities is quilting.
Image by Gina Pina FLIKR

Carol is a 65 year old female, who has never smoked, has no family history of any lung disease, has never had any type of ailments relating to lungs, and did not have any breathing issues prior to 2013. In May of 2013, she found herself having difficulty breathing when climbing stairs. She made an appointment to see her doctor. The doctor suggested the cause could be lung related. A chest x-ray was the first step in the diagnosis.

After reviewing the chest x-ray, the doctor recommended that she see a pulmonologist. The pulmonologist put Carol through a regiment of tests, CT, EKG and a Pulmonary Function Test (PFT). After all these test the pulmonologist diagnosed Interstitial Pulmonary Fibrosis (IPF). Carol and her husband were shocked. Carol had never smoked, never worked in any environment that would have caused an injury to her lungs, and never had any type of lung issues at all.

What we do know about IPF is that there is no root cause to this disease. As with many of the people that have IPF, there is no one factor that stands out among IPF patients. Some IPF patients have a history of having been in potentially toxic conditions that could cause an injury to the lungs, yet others like Carol, have never even been sick with any lung type illnesses. This is the very difficult part of understanding Pulmonary Fibrosis.

The pulmonologist suggested Carol undergo a lung biopsy to confirm the diagnosis. She and her husband had a trip planned within the upcoming weeks. They felt as though they should go on the trip and wait for Carol to have the biopsy when they returned. In June of 2013 Carol underwent the biopsy and it did confirm that she had Interstitial Pulmonary Fibrosis.

In the past year Carol has been very aware of her disease. As it has impacted her life she has made changes where needed. Carol has learned to do many of the same things she did before, however taking a bit more time so that she can maintain an adequate level of breathing. She is very active with grandchildren, exercising, and involved in the community.

Recently, Carol has felt as though the fibrosis is progressing. During one of her pulmonary rehab sessions, her oxygen levels dropped a bit which concerned the specialist. Her pulmonologist suggested that it may be time for her begin the use of oxygen when she is exerting herself. She will be undergoing another PFT, which will help to determine if there is a need for supplemental oxygen and if so what level of oxygen she would need during exercise.

As with many IPF patients, Carol, seems to be understanding of her condition and is weighing all the options. She continues with life’s daily activities, enjoying her grandchildren, and takes one day at a time.

The Second Wind Foundation would like to thank Carol and her family for agreeing to provide us with her story. We urge others to help spread their story about Pulmonary Fibrosis. If you’re interested in helping our organization help others understand this disease, please contact us at info@secondwindforpf.com.