Letter I sent to FDA regarding Nexavir

[Guest guest]

Hello,

This is the letter I sent to the FDA representative who goes to the Chronic

Fatigue Syndrome Advisory Committee meetings in Washington, DC twice a year.

This is his full title:

Marc W. Cavaille-Coll, MD, PhD-- 301-796-1600 fax-- 301-796-9880

Medical Officer Team Leader

Division of Special Pathogens and Immunologic Drug Products

Du Pre

Poetry website: http://www.angelfire.com/poetry/soareagle/index.html

" By words the mind is winged. " Aristophanes

Website for National Alliance for Myalgic Encephalomyelitis:

http://www.name-us.org

Dr. Cavaille-Coll:

I have seen that you are a member of the CFSAC group, and I would like to ask

for your assistance in having Nexavir approved by the FDA for use with CFS

patients. As you may know, Kutapressin (now Nexavir) had been used successfully

with CFS patients, but it went out of production in the year 2003. Recently, it

has been reintroduced as Nexavir with the exact same ingredients and

prescription insert and so on by Nexco Pharma (contact information below). My

HMO, Kaiser Permanente covered this drug up until it went out of production in

2003. Now, with its reintroduction as the drug, Nexavir, Kaiser has refused to

approve it by saying that it is not FDA approved.

The Kutapressin worked wonders for my fatigue, and flu-type symptoms, which

included swollen lymph glands, sore throat, low-grade fever, etc. Those with

viral reactivation of the herpes viruses which include Epstein-Barr, HHV-6,

etc., were given Kutapressin. That viral reactivation causes the flu-type

symptoms a lot of the time. Kutapressin was my main drug, so I'm so thankful

that Nexco has brought it back to market. Ku is indicated and was approved for

Herpes Zoster. The drug was was approved back in the 1940's for the treatment

of herpes. Approval has never been withdrawn. KU is PATENTED for an indication

for CFS.

Dr. Cheney's recent research using Nexavir has indicated excellent results

in his clinical trials as evidenced in his recent 2 DVD lecture:

DISC ONE

a.. Dr. Cheney's Opening Remarks (0:00)

b.. Principles Important in CFS (7:30)

many fascinating observations!!

c.. Case Definition and Important Clinical Findings (20:00)

includes the four phases of CFS

d.. Key Medical Literature (24:46)

many citations of published works, by category

e.. Objective Database (26:16)

includes graph of four phases of CFS, recovery trajectory, physical exam

findings, immune activation, sub-cortical brain injury, metabolic disturbances,

pulse-oximeter data, Oxyhemoglobin Dissociation Curve, exercise ergometry,

fingerprint changes & biopsy of tissue, immunity pathway, RNase-L activity, MRS

results, MRI results, blood gas test results: mixed venous hypoxia

f.. Models of Pathophysiology: circa 1995 and 2004 (49:43)

includes mitochondrial impairment, the 4 phases, altered gene expression,

energy conundrum, Dr. Pall's work, neurotransmitters & SSRIs

g.. Evidence of Diastolic Dysfunction and Heart Failure (1:08:41 - 1:44:36)

includes cardiac output, cardiomyopathy, brain - adrenal - heart axis,

hypothyroidism, micro vs macro circulation, echo vs impedance testing, order of

sacrifice, diastolic vs systolic heart failure, pulmonary hypertension,

echocardiography in CFS:

a.. diastolic or energetic dysfunction;

b.. cavitation of left atrium on head up tilt;

c.. LV wall thickening;

d.. wall motion aberrancies;

e.. positive response to magnesium;

f.. positive response to Nexavir;

g.. PFO's and oxygen toxicity.

Cardiomyopathy & CFS, diastolic vs systolic problems, E and A wave forms, E/A

ratio, echo Tissue Doppler Imaging (TDI), e'/a' ratio, D/S ratio, Summary of

Diastolic Parameters

DISC TWO

a.. Evidence of Diastolic Dysfunction and Heart Failure cont'd (0:00)

includes left atrial cavitation, E/e' ratio, summary of other parameters, IVRT

shifts with magnesium, IVRT shifts with Nexavir, left ventricular wall

thickening and asynchrony, ischemic changes in the inter-ventricular wall

b.. Evidence of Tight Association of CFS with PFO's (10:20)

Patent Foramen Ovales (includes oxygen toxicity)

c.. An Emerging Physiologic Model (circa 2006) (20:03)

includes PFO complications, Venous Hypoxemia complications, Diastolic

Dysfunction vs Diastolic Heart Failure

d.. Treatment Approaches (26:55)

includes the study protocol and results to date, echo parameters measured as

part of the study, gene expression and cell signaling factors

Below are studies that have been done in on Kutapressin in the past as well

as information on Nexco Pharma which is now producing Nexavir. Also, I gave the

FDA website information for you.

A number of patients would appreciate your help and intervention in getting

this on the FDA approved list since it is a very safe but effective drug for a

subset of CFS patients.

Thanks for any assistance you can give,

Du Pre

Vice President, California Capital CFIDS Association

Carmichael, California

Telephone: 916-486-6250

Message telephone: 916-494-3207

In Vivo. 1994 Jul-Aug;8(4):581-6.

___ Antiviral activity in vitro of Kutapressin against human

herpesvirus-6.

Ablashi DV, Berneman ZN, Lawyer C, Kramarsky B, Ferguson DM, Komaroff

AL.

*** National Cancer Institute, Bethesda, MD 20892. ***

The recently discovered human herpesvirus-6 (HHV-6) is being

associated with an increasing number of conditions in which there is

evidence of immunologic dysfunction.

A number of widely available antiviral agents have shown little or no

activity against the virus. We found that Kutapressin (KU), a drug

that has been available to practicing physicians for over 50 years,

has potent, previously unexpected antiviral effects.

Cells known to allow replication of HHV-6 were infected with the

virus, under various conditions. Either pretreatment of the cells

prior to infection or treatment shortly after infection, inhibited

viral replication by > 90%.

Indirect evidence suggests that KU may inhibit viral attachment to

cellular receptors, and inhibit intracellular maturation of the

virus. Given these in vitro findings, and the low frequency of

toxicity reported with the use of KU, clinical trials of this drug in

patients with evidence of reactivated HHV-6 infection would seem to

be warranted.

PMID: 7893985 [PubMed - indexed for MEDLINE]

In Vivo. 1996 May-Jun;10(3):313-8.

___ Potential in vitro activity of Kutapressin against Epstein-Barr

virus.

Rosenfeld E, Salimi B, O'Gorman MR, Lawyer C, Katz BZ.

*** Department of Pediatrics, Northwestern University Medical School,

Children's Memorial Hospital, Chicago, IL 60614, USA. ***

BACKGROUND: Kutapressin (KU), a porcine liver extract with

bradykinin-potentiating effects but no vitamin B 12 activity, has

been used in the treatment of Herpes zoster. We examined a phenol-

free preparation of this drug for in vitro activity against Epstein-

Barr Virus (EBV).

MATERIALS AND METHODS: Immortalization-inhibition assays were used to

assess EBV infectivity. Mitogen stimulation and cell viability assays

were used to assess kutapression toxicity. Lytic replication assays

and flow cytometry were used to assess the mechanism of drug

activity.

RESULTS: Seventy-five hundred mcg/ml of KU blocked the infection of 2

x 10(5) human umbilical cord mononuclear cells when added together

with two strains of EBV (B95-8 and FF41). Doses as low as 250 mcg/ml

were occasionally effective as well. Unlike acyclovir, KU does not

inhibit viral DNA polymerase nor does it appear to compete with EBV

as it binds to its receptor on the B-cell surface.

CONCLUSIONS: The mechanism whereby KU may inhibit EBV immortalization

remains to be determined. KU, a drug which is safe in humans,

deserves further study as an agent with potential to block EBV-

induced immortalization of B-lymphocytes.

PMID: 8797033 [PubMed - indexed for MEDLINE]

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Previous Trade Name NDC Number Strength Firm Name

KUTAPRESSIN INJECTION 0091-1510 25.5MG SCHWARZ PHARMA INC

KUTAPRESSIN INJECTION 11098-304 25.5MG/ML TAYLOR PHARMACEUTICALS

Present FDA listing for Nexavir:

Here is the FDA webpage, with two listings for Nexavir:

http://www.accessdata.fda.gov/scripts/cder/ndc/gettradename.cfm

and another FDA page, with Nexavir:

http://www.accessdata.fda.gov/scripts/cder/ndc/gettradenamedet1.cfm?prodcode=081\

5 & lblcod=15801

and another FDA page, with Nexavir:

http://www.accessdata.fda.gov/scripts/cder/ndc/gettradenamedet1.cfm?prodcode=081\

5 & lblcode=10530

The NDC number for Nexavir is 10530-0815-13.

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Reintroduction of Kutapressin using the name Nexavir

http://www.nexcopharma.com/

Nexavir (replacement for Kutapressin) is now available for sale. If

your doctor gives you

a prescription, your pharmacy anywhere in the US should be able to

order Nexavir from the

manufacturer:

Nexco Pharma

P.O. Box 820023

Houston, Texas 77282-0023

Phone: 713-896-4949

Fax: 713-896-0176

info@...

orders@...

Web Site: http://www.nexcopharma.com/

Package insert: http://www.nexcopharma.com/nexavir-insert.htm