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Treatment for Blood disorders


Up to now, several hundreds of hematologists have prescribed AryoSeven™ for treatment of several thousands of their patients.

AryoSeven™ is recombinant activated human blood coagulation factor VII, produced by Aryogen Biopharma under cGMP and EU regulations. It is used for treatment of patients with coagulation Factor VIII deficiency which has developed neutralizing antibodies against Factor VIII and also for patients with factor VII deficiency.

AryoSeven™, Human activated recombinant blood coagulation factor VII (rFVIIa), is a glycoprotein with 406 amino acids and molecular weight of about 50 KD, which is produced in Baby Hamster Kidney cell line (BHK) via recombinant technology and is secreted as a single chain zymogene into medium.  Secreted crude Factor VII is then highly purified to be acceptable as injectable human drug. During purification process, this single chain molecule changes into its double chain activated form as serine protease.

FVII contains four separated domains: a gamma-carboxyglutamic acid domain in amino terminal, two epidermal growth factor-like (EGF-like) domains and a serine protease domain.

As mentioned, transformation of this zymogene to activated enzyme is done during purification process.   As a result, rFVIIa contains two jointed peptide chains, a light chain of 152 amino acids and a heavy chain of 254 amino acids. These chains are attached with a disulfide bond.

Factor VII is a vitamin K-dependent gamma -carboxylated glycoprotein, which in its activated form, FVIIa, activates FX to FXa and FIX to FIXa by limited proteolysis. FVIIa full enzymatic activity is appeared when is complex to tissue factor (TF) in the presence of calcium ions. Gamma-carboxyglutamic acid groups in light chain are essential for FVII proteolytic activity.

 

This biosimilar medicine is produced under strict cGMP standards and is formulated totally similar to the original drug and also has similar characteristics and functions with the native human blood factor VII.

  The product is actually the first biosimilar or biogeneric of the original drug with a totally approved similarity.

 

Recommended International Nonproprietary Name (INN)

Eptacog Alfa (Activated)

Chemical name

Blood-coagulation factor VII (Human clone λHVII2463 protein moiety)

Chemical Abstracts Service (CAS) registry number

102786-52-7, 102786-61-8

Anatomical Therapeutic Chemical (ATC) code

B02BD08

Molecular formula

C1972H3076N560O597S28

 

 

>>AryoSeven™ clinical trials

AryoSeven™ has proven to be as safe and effective as branded activated human recombinant blood coagulation factor VII. AryoSeven™ is fully characterized in molecular level by us and or third parties including regulatory and other third party laboratories and highest imaginable similarity has been found so that it is not distinguishable from branded drug in most of the characteristics.

Also several clinical trials has done and there was no significant difference in baseline characteristics between two arms in each trial.

 

Randomized double blind multicenter clinical trials were performed on Iranian patients with congenital factor VII deficiency and hemophilia with inhibitors. Patients were enrolled in two parallel arms, comparing AryoSeven™ with branded recombinant factor VIIa. There was no significant difference in baseline characteristics between two arms in each trial.

 

             
  • Results in congenital factor VII deficiency clinical trial showed that:

1. Both arms were comparable based on increment in serum level of FVII. Calculation of p-values confirmed that the groups have shown no significant difference.

2. Bleeding events were reduced during treatment in both study arms equally and no significant difference was observed.

3. Severity of bleedings was reduced during treatment in both study arms equally and no significant difference was observed.

4. Occurrence of adverse events was similar in both arms.

 

  • Results in Hemophilia patients with inhibitor clinical trial showed that:

1. Both arms were comparable based on Kavakli global response scoring system which is a novel method for assessment of pain and range of motion in joints following administration of rFVIIa for treatment of bleeding episodes. Calculation of p-values confirmed that both arms have shown no significant difference.

2. Both arms were comparable based on increment in serum level of FVII. Calculation of p-values confirmed that the groups have shown no significant difference.

3. Occurrence of adverse events was similar in both arms.

AryoSeven™ is available as lyophilized powder (Cake) in 2 ml vials along with a vial of water for injection. Each dose contains 1.2 mg of active protein which is equal to 60 thousands international unit of biological activity.

 

If you need more information on AryoSeven™ please contact our consulting team at Aryogen office or go to its website www.aryoseven.com for more detailed description.

   
 

Hemophilia is mostly a boys disease. Many boys like above pictured one are happy that the disease fortunately is a rare one.



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