2010 New Patent covering therapeutic application of HPH-116 is published

Virus-based vaccine composition having a protein with zinc finger pattern(s), method of preparing and using same

Vaccine composition made of at least one virus strain exhibiting at least one protein having zinc finger motifs, comprises: virus in an inactivated state in which zinc was ejected from the protein by one redox reaction with azodicarbonamide, where the virus is entire and has a viral envelope intact after inactivation; biurea formed from azodicarbonamide during the redox reaction; and optionally an unreacted azodicarbonamide residue. An independent claim is included for preparing the vaccine composition, comprising: contacting the virus strain exhibiting the protein with micronized azodicarbonamide; penetrating micronized azodicarbonamide through the viral envelope of virus by leaving the envelope intact; and inactivating the virus by a redox reaction between micronized azodicarbonamide and the protein resulting by an ejection of the zinc from the protein and a partial decomposition of azodicarbonamide into biurea. - ACTIVITY : Virucide. - MECHANISM OF ACTION : Vaccine.

Conclusion

In this annual safety report, all safety information on HPH116 (ADA) received and assessed by the sponsor in the period from 08-Mar-2007 up to and including DLP 10-Mar-2008 has been reviewed. In conclusion, no specific areas of concern have been identified during the reporting period. No single SAR was reported in the exposed clinical trial with 33 HIV patients; this confirms the beneficial safety profile of HPH116. During the period of this annual safety report no significant safety-related issues have been identified. All relevant information stated in this report will be incorporated in the next update of the IB.

Gosselies (Belgium), February 2007

H-Phar announces that its galena form HPH116 successfully achieves a phase 1 clinical trial including 12 healthily volunteers in Clinica Santa Elena, Calle Sardino s/n, Los Alamos, Torremolinos, 29260 Malaga, Spain

An open, single-dose, two ways cross-over, food interaction study to assess the safety, bioavailability and pharmacokinetics of HPH116

Safety Results

Treatment-emergent adverse events occurred in comparable frequency under fasting (41.7%) and non-fasting (50.0%) conditions of HPH116 administration. All AEs were of mild to moderate intensity. Most of the treatment emergent adverse events were reported once. AEs reported more than once were headache, injection site reactions and dysmenorrhoea

Mean biurea plasma concentration during 24h period after 600 mg HPH116 under fasting and non-fasting conditions

Gosselies (Belgium), Friday June, 10; 2005

H-Phar announces that its galena form HPH116 successfully achieves a phase 1 clinical trial including 50 healthily volunteers in “D.R.U.G.” located in University Hospital Gent, De Pintelaan 185, B-9000 Gent, Belgium. No adverse events were reported at doses up to 6.000 mg of active compound (1 day) and 2.400 mg (7days). In particular, the kidney function was carefully followed using erythrocytes and lymphocytes counts Surrogate markers of tubular, interstitial and glomerular cells injuries were measured. No casts or crystals in urine were observed using flow cytometry (1). Urinary casts are formed only in the distal convoluted tubule (DCT) or the collecting duct (distal nephron). The proximal convoluted tubule (PCT) and loop of Henle are not locations for cast formation. Red blood cells may stick together and form red blood cell casts. Such casts are indicative of glomerulonephritis, with leakage of RBC's from glomeruli, or severe tubular damage. White blood cell casts are most typical for acute pyelonephritis, but they may also be present with glomerulonephritis. Their presence indicates inflammation of the kidney, because such casts will not form except in the kidney. Kidney follow up was completed by urine markers: retinol binding protein (index of proximal tubular injury) - b2-microglobulin (Low molecular weight molecule B2 microglobulin, has a molecular weight of about 25000. This small protein is easily filtered across the basement membrane and then normally completely reabsorbed by the proximal tubular cells. A variety of diseases that produce tubular and interstitial injury impair the tubular reabsorption of this molecule). - b-NAG (N-acetyl-beta-glucosaminidase) (Among patients with predominantly glomerular disorders there was a close relationship between activity of the disease and Nacetyl- beta-glucosaminidase concentration). None of those parameters showed significant variations during the Phase 1 clinical trials.

In combination with the ICH animal models required pre clinical data (including renal histological examinations), this finding seems to exclude kidney toxicity of HPH116.

(1) Clinical Chemistry. 1999;45:118-122.
© 1999 American Association for Clinical Chemistry, Inc.
Automated Flow Cytometry Compared with an Automated Dipstick Reader for Urinalysis
Michel R. Langlois1, Joris R. Delanghe1, Sophia R. Steyaert1, Karel C. Everaert2 and Marc L. De Buyzere1
Departments of 1 Clinical Chemistry and 2 Urology, University Hospital Gent, De Pintelaan 185, B-9000 Gent, Belgium.

Personne de contact:

Docteur Michel Vandevelde H-Phar 14, avenue des Bouvreuils B-1301 Bierges Belgium
vandevelde.dr@skynet.be
Tél. +32 10 41 70 78 Fax 32 10 41 42 47