Dear Donor:

To say “thank you” seems somehow off-the-mark, given the fact that your generosity of time and energy is what has kept me alive this last year and a half.  Nonetheless, I will say “thank you” and that I appreciate what you have done for a fellow stranger.  You have not only helped me in my treatment of my cancer, but have made a wife and 2 little boys very happy to still have their husband and daddy around.

A little about me: I have been married for 9 years and have two sons, ages 17 months and 5 ½ years old.  My youngest was born at the same time that I was in the hospital post-transplant with your stem cells!  Crazy how life takes us on these twisted paths.  I would have never guessed that I would have ended up here, but here I am.

I was diagnosed with cutaneous T-cell lymphoma in 2006, a very rare cancer that produces tumors and lesions on the skin.  Mine came about very aggressively and with all of the treatments that we threw at it, none had much of an effect except full-body radiation.  After that pushed the cancer back, the only hope for survival was deemed to have fresh stem cells from a matched donor.  While there have been many side effects that have come on since the transplant, I am very fortunate to have been matched to yours as that led to a fairly uneventful procedure (you certainly do not want anything too exciting to happen with any of this! Easy and boring is the way to go).

I work as a Human Resources manager for a medical education company, that of all things trains physicians on the latest treatment modalities in cancer, even specifically lymphomas like mine!  My employer has been very gracious and allowed me to have spent up to 14 months out of work while I prepared and had the transplant last year.  Again, the hardest part has not been the actual transplant but the side effects ever since then.  I can hardly complain and would like for you to know that your selfless act has transformed my life and those around me.  You have touched hundreds of people in ways that you couldn’t possibly know, all for the better.  I maintain online blogs that thousands have read; many have been sending you prayers and wishes for good fortune for the better part of 2 years now.

I have wondered often who you are and what you are doing.  At the minimum, I can say that I wish you well in all that you do.  Your very act of going to the doctor and having the procedure to remove the stem cells has so immensely affected my life that I can’t overstate what you have done for me.  In the truest sense, you are my angel.  I know this may all sound a bit creepy and such, but while there may have been other matches, you in particular held out for me and set aside time to help out a complete stranger.  To get even weirder for a moment, your DNA is in my soft tissues and thus we have the same blood in us!  It’s not misleading to say that I will always have you around with me!

Anyway, without knowing you it’s hard to know how to approach this letter and try and connect with you.  I hope I haven’t offended you in anyway.  I am merely grateful for your actions and hope to have further correspondence with you.

All my best,

Your recipient

FDA Approves Gloucester Pharmaceuticals’ ISTODAX^® for Patients with

Cutaneous T-cell Lymphoma

– Overall response rates exceeded primary endpoint in ISTODAX studies; sustained duration of response reported –

Cambridge, MA – November 5, 2009 – Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX^® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response. The New Drug Application (NDA) included efficacy data from two studies encompassing 167 patients. ISTODAX is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and is expected to be commercially available in January 2010.

“CTCL is a devastating cancer in which many patients suffer from disfiguring tumors, horribly itchy and infected skin and, in advanced stages, lesions in other organs,” said Youn Kim, MD, an investigator in studies of ISTODAX and Professor, Department of Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Program, Stanford Cancer Center, Stanford, CA. “Current systemic therapies have proved inadequate and patients with CTCL desperately need treatment options that can offer sustained relief from their disease so they can live fuller lives. ISTODAX meets a significant unmet need and provides hope for patients with CTCL, their families and their physicians.”

Paul A. Bunn, Jr., MD, James Dudley Chair in Cancer Research, Professor and Director, University of Colorado Cancer Center and past-President of the American Society of Clinical Oncology said, “ISTODAX offers physicians an important new treatment choice that can provide clinically meaningful, and, most importantly, sustainable responses for some patients with CTCL who have failed prior systemic therapy. Additionally, the approval of a second HDAC inhibitor in cancer is very exciting and speaks to the potential for this class of compounds.”

“The approval of ISTODAX is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the ISTODAX clinical trials,” said Jean Nichols, PhD, President and Chief Operating Officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of ISTODAX.”

Alan Colowick, MD, Chief Executive Officer of Gloucester Pharmaceuticals said, “The approval of ISTODAX is a tremendous accomplishment for Gloucester Pharmaceuticals and for the patients we serve. This milestone is also an important step in the continued clinical development path for ISTODAX in oncology. We look forward to presenting data from our registration study of ISTODAX in peripheral T-cell lymphoma in 2010 and continuing further investigation in additional hematologic indications and solid tumors.”

About CTCL
CTCL is a type of non-Hodgkin’s lymphoma, which is a cancer of the immune system. CTCL is caused by a mutation of T cells, unlike most non-Hodgkin’s lymphomas which are generally of B-cell origin. The malignant T cells involve the skin, causing plaques, patches, erythroderma and/or tumors and can involve other organs, including the blood, lymph nodes and viscera.

Clinical Trials Overview
The ISTODAX approval was based upon two prospective multicenter, single-arm clinical studies in patients with CTCL. 167 patients with CTCL were accessed for efficacy in the United States, Europe and Australia. Study 1, sponsored by Gloucester, included 96 patients with confirmed CTCL after failure of at least 1 prior systemic therapy. Study 2, sponsored by the National Cancer Institute, included 71 patients with a primary diagnosis of CTCL who received at least 2 prior skin directed therapies or one or more systemic therapies. Patients were treated with ISTODAX at a starting dose of 14 mg/m2 infused over 4 hours on days 1, 8, and 15 every 28 days.

In both studies, patients could be treated until disease progression at the discretion of the investigator and local regulators. Objective disease response was evaluated according to a composite endpoint that included assessments of skin involvement, lymph node and visceral involvement, and abnormal circulating T-cells (“Sézary cells”).

The primary efficacy endpoint for both studies was overall objective disease response rate (ORR) based on the investigator assessments and defined as the proportion of patients with confirmed complete response (CR) or partial response (PR). CR was defined as no evidence of disease and PR as ≥50% improvement in disease. Secondary endpoints in both studies included duration of response and time to response.

The ORRs in these two trials were similar (34% and 35% in Study 1 and Study 2, respectively) and CR rates were the same (6%). The median response duration was 15 months (range of 1 to 20+ months) in Study 1 and 11 months (range of 1 to 66+ months) in Study 2. Median time to first response was 2 months (range 1 to 6) in both studies. Median time to CR was 6 months in Study 1 and 4 months in Study 2 (range 2 to 9). The most common adverse reactions in Study 1 were nausea, fatigue, infections, vomiting and anorexia and in Study 2 were nausea, fatigue, anemia, thrombocytopenia, ECG T-wave changes, neutropenia and lymphopenia. See below for important safety information.

In Study 1, the median number of prior skin-directed therapies was 2 and the median number of prior systemic therapies was 2. In Study 2, the median number of prior skin-directed therapies was 1 and the median number of prior systemic therapies was 2. In Study 1, 71% of the patients had Stage IIB or greater disease and 87% of the patients in Study 2 had Stage IIB or greater disease.

Important Safety Information
ISTODAX is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Warnings and Precautions
Due to the risk of QT prolongation, potassium and magnesium should be within the normal range before administration of ISTODAX.

Treatment with ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; therefore, these hematological parameters should be monitored during treatment with ISTODAX, and the dose should be modified, as necessary.

Several treatment-emergent morphological changes in ECGs including T‑wave and ST-segment changes have been reported in clinical studies. The clinical significance of these changes is unknown. In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, appropriate cardiovascular monitoring precautions, such as the monitoring of electrolytes and ECGs should be considered.

Based on its mechanism of action, ISTODAX may cause fetal harm. Woman should avoid becoming pregnant while being treated with ISTODAX and pregnant women should be advised of the potential harm to the fetus.

ISTODAX binds to estrogen receptors. Women of childbearing potential should be advised that ISTODAX may reduce the effectiveness of estrogen-containing contraceptives.

Adverse Reactions
Safety data was available and evaluated in 185 patients with CTCL in two clinical trials. Adverse reactions are presented separately for each study due to methodological differences between the studies. The most common reported adverse reactions in Study 1 were nausea (56%), fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%) and in Study 2 were nausea (86%), fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG T-wave changes (63%), neutropenia (57%), and lymphopenia (57%). Most of the adverse reactions were reported to be mild or moderate in severity. Most deaths in the studies were due to disease progression. Discontinuation due to an adverse event occurred in 21% of patients in Study 1 and 11% in Study 2. Serious adverse reactions reported in > 2% of patients in Study 1 were infection, sepsis, and pyrexia. In Study 2, serious adverse reactions in > 2% of patients were infection, supraventricular arrhythmia, neutropenia, fatigue, edema, central line infection, ventricular arrhythmia, nausea, pyrexia, leukopenia, and thrombocytopenia.

Drug Interactions
Prothrombin time (PT) and International Normalized Ratio (INR) should be carefully monitored in patients concurrently administered ISTODAX and Coumadin derivatives.

Co-administration of strong CYP3A4 inhibitors may increase concentrations of ISTODAX and should be avoided.

Co-administration of potent CYP3A4 inducers may decrease concentrations of ISTODAX and should be avoided.

Caution should be exercised if ISTODAX is administered with drugs that inhibit P-glycoprotein.

Use in Specific Patient Populations
Patients with moderate and severe hepatic impairment or end-stage renal disease should be treated with caution.

For additional important safety information, please see full prescribing information for ISTODAX at www.ISTODAX.com or call 1-866-223-7145.

About Gloucester Pharmaceuticals
Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and advances them through regulatory approval and commercialization. The Company’s first candidate, ISTODAX^® (romidepsin), a novel histone deacetylase (HDAC) inhibitor, is FDA approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. Gloucester is currently conducting a registration trial in peripheral T-cell lymphoma (PTCL) and anticipates data from this study in 2010. In addition, the Company is continuing further investigation of ISTODAX in other hematologic indications and solid tumors. For more information, please visit www.gloucesterpharma.com.

• Nipent (by Hospira) is in Phase III for graft vs. host disease.
• orBec, has had the FDA application submitted.  It’s made by DOR BioPharma and Sigma-Tau.
• Prochymal, made by Osiris Therapeutics, in Phase III
• Prograf, made by Astellas, application submitted

What wonderful news.  To my knowledge, there are few if any drugs and/or treatments specifically indicated by the FDA for GvHD.  Perhaps these can be fast-tracked for approval and get out there so that we can have more tools in our arsenal against this insidious disease.  God give us strength.

Speaking of drugs.  I just printed off a medication co-pay list from Kroger for the National Marrow Donor Program co-pay relief fund and see that I paid out-of-pocket $588 during the last 90 days for 38 prescriptions filled!!  The insurance portion was $7,000!!! That is just for 90 DAYS!  No wonder our money is tied-up.  That’s about $300 or so a month just in drug co-pays, notwithstanding doctor co-pays, which would add another $100 or more a month.

Therefore, I am paying around $400 a month just on CO-PAYS!  Good golly Miss Molly!

I am extremely thankful for the assistance funds that are out there like the Healthwell Foundation (has a non-Hodgkin’s and CTCL disease funds), the Patient Access Network Foundation (same thing, non-Hodgkin’s and CTCL funds are available), the National Marrow Donor Program, and others.  However, it looks like this year I may be denied funds from both the Healthwell and PANF foundations since my drugs are less disease-related and more symptom-related, which does not qualify for either of their funds.

The idea is that you have to have active treatment specifically for your disease, not drugs and treatments for the side-effects or maintenance of your well-being such as antibiotics and the like. Thankfully, both do cover Prednisone!!

Well, we shall see if I qualify this year for their programs.  I certainly hope so as it has made the difference for the past 2 years.  If not, I’ll search out other programs, but since I am working and have good health insurance it is unlikely I will qualify for many (if any) other programs.

If you know of any others that I could qualify for, please let me know!!

Ciao for now,

Nick

May those that suffer have gained wisdom to move beyond the pain and realize that their suffering is in the name of God.  Humanity benefits when we each overcome and go beyond our individual pain and give it up to God.  Then, the suffering is not in vain but rather a gift, a way to connect to others and the divine.

God bless us all.

It seems that I am stuck in this cyclical life of get up, deal with the issues of discomfort so I can function, feel good enough until about 3 or 4 pm and then the aches, pains, tightness, and burning set in again.

I am back to stretching again with weights, an excercise ball, yoga, the “Thumper” (a wonderful handheld electric massager with 2 large “thumpers”), drinking more water and all the rest of it.  In fact, I took the boys and a neighbor girl to the river for a walk today.  Felt great to get out and walk among the trees and river. Katie took the BMW and went shopping!

Anyway, I know there are a lot of you out there that feel the same; that everyday seems to not be noticeable better than the previous one.  Each day seems like another version of the day before and in a way is kinda like a living hell on earth! (Well, I say that, but the moments in between the pain are nice and I can enjoy them).

Well, the troops just came in and I dinner must be made, kids tended to, and the rest of it . . .  . . .  Life just kinda happens you know. Look! Here it comes again!