Issar Pharmaceuticals Pvt. Ltd. (Issar Pharma) is a pioneer in the research and development of peptide-based health care products and their commercialization. With a state-of-the-art facility located in the industrial area of Medchal, Hyderabad, India. Issar Pharma is using the most modern and advanced automatic equipment for the development, synthesis, purification and manufacture of peptide-based drugs. The company has received permission from the Drugs Controller General (I) to manufacture first ever new molecule, a Decapeptide1, and its application as a re-pigmentation agent in the novel treatment of vitiligo. This product was released into the market in 2004 under the brand name Melgain® after six years of committed research.
The company has additional peptides patented for the treatment of burn wound sepsis, tumor regression, and the metastasis inhibition of different cancer diseases. These peptides are in different stages of toxicological and safety evaluations and clinical trials. Issar Pharma is planning to release individually after completion of the necessary studies and receipt of required permissions.
Below is a brief introduction of some of the projects under development by Issar Pharma. It is expected that these will all be taken up for commercialization in the near future.
Genopep (GNP) is a synthetic antimicrobial peptide (AMP) under development as a lead compound for infected burn wound; burn wound sepsis and wound healing. This antimicrobial peptide was developed on the principles found in naturally occurring antimicrobial peptides, though this compound shows a greater spectrum of activity against many infectious agents, including multi drug – resistant strains of Pseudomonas aeruginosa and Staphylococcus aureus.
Studies have shown that very low concentrations of the Genopep peptide can kill up to 100% of wound sepsis bacteria, while safety and toxicological evaluations of the peptide have demonstrated that it is safe even in high concentrations. Studies using a rat burn-wound model showed that the peptide is very effective in reducing wound bacterial load and increasing survival of animals. Clinical trials are at different phases of clinical trials at various hospitals though Genopep shows enormous promise in treating humans with burn wound sepsis and wound healing.
Genopep 1 (GNP 1) is an anti-tumor regression peptide of Issar Pharmaceuticals under development as a lead compound for solid tumor treatment. Acute, sub-acute, and chronic or long term studies on mice, rats and rabbits have been successfully completed. Toxicological safety studies are in different stages of evaluation in India.
Efficacy studies in vitro are in the final stages and efficacy studies in vivo (in nude mice) have been initiated. In the former, several test environments were used to evaluate the peptide’s activity against human cancer tumor cells, including breast, melanoma, and ovarian, renal cancer cells. These studies showed consistent and effective cytotoxicity, resulting in the decision for further study of this molecule. In the latter in vivo efficacy studies, PC-3 cells, or MLL cell lines, were injected into the left and right flanks of athymic nude mice, allowed to grow and then treated with varying doses of GNP1 (100-1000 n mol/50 µl). Subsequent evaluation of tumor growth in these studies identified complete tumor regression in nearly all mice. GNP 1 also exhibited time and dose dependent cytotoxic activity.
Genopep 1A is a modified version of Genopep 1. It has shown a clear effect on sexually transmitted disease-causing organisms, such as Chlamydia and Trichomonas, and applications for many other disease-causing viruses.
Genopep 1B, another patented peptide of Issar Pharma has identified as an effective control of Burkholderia – Cepacia, the pathogen that causes the fatal disease known as cystic fibrosis, which is generally quite resistant to traditional antibiotic-based therapy. Safety and toxicological evaluations and efficacy studies are to begin shortly.
The Genopep 2 peptide has been newly developed by Issar Pharma as an effective systemic anti-cancer agent. The toxicological safety studies are in different stages of evaluation in India, the efficacy studies in vitro are in the final stages and efficacy in vivo (in nude mice) have also been initiated. The acute, sub-acute, and chronic studies on mice, rats and rabbits have been successfully completed.
In addition to Melgain®, Issar Pharma has developed products for various dermatological conditions, including psoriasis, pruritic inflammatory skin diseases and fungal ailments.
The company’s skin care line, Normaderm, was launched in 2006 with a number of different creams and ointments. These include:
Normaderm cream (containing Clobetasol Propionate USP 0.05%) for inflammatory and pruritic manifestations of steroid dermatoses.
Normaderm – S ointment (containing Clobetasol with moisturizing factors, salicylic acid, urea and lactic acid) for hyper-keratotic dermatoses.
Normadern – GM cream (containing Clobetasol with Gentamycin and miconazole) for complicated skin infections.
An antifungal cream with terbinafin hydrochloride was developed and launched in 2006 under the trade name Binafin.
There are also plans to introduce a topical treatment for Melasma and various other dermatological problems.
Note : 1Dr. A Ramaiah is the inventor and the Indian patent is jointly owned by Issar and Dr. A Ramaiah and exclusive right to manufacture and sell the product in India is given by Dr. A Ramaiah to Issar.