Quick & Scarless Healing

Diabetic Foot Ulcers

Pressure Ulcers Including Bedsores

Venous Leg Ulcers

Reference:

  1. Viswanathan V. A phase III study to evaluate the safety and efficacy of recombinant human epidermal growth factor (Regen-D 150) in healing diabetic foot ulcers. WOUNDS. 2006;18(7):186–196.
Diabetic foot ulcer (DFU)*

Average healing time1

  • Test group (REGEN-D® 150) : 9 weeks.
  • Control group (placebo) : 15 weeks.

Efficacy of REGEN-D® 150

Adapted from Vishwanthan V, 2006.

*Phase III Study.

Reference:

  1. Viswanathan V. A phase III study to evaluate the safety and efficacy of recombinant human epidermal growth factor (Regen-D 150) in healing diabetic foot ulcers. WOUNDS. 2006;18(7):186–196.
DFU – Post-marketing Surveillance (PMS) Study *
  • The average wound healing in patients was 86% & the average wound healing time was 4.8 weeks in the PMS study.1
  • No adverse events were reported in patients during the PMS study.1

Cumulative Percentages of Healing

Adapted from Mohan V.K, 2007.

*Phase III study.

Reference:

  1. Mohan VK. Recombinant human epidermal growth factor (REGEN-D™ 150): Effect on healing of diabetic foot ulcers. Diabetes Res ClinPract. 2007;78(3):405-411.

The proportion of patients cured by week 10 was ~ 92%, ~ 69% and ~ 21% in the PMS study, Phase III (Test Group) and Phase III (Control Group), respectively.1

Bedsores (Pressure Ulcers)*

Average time to complete healing

  • Test group REGEN-D® 150 : ~40days.
  • Control group : ~79days.

Efficacy of REGEN-D® 150

Adapted from Phase III Clinical Trial Report in Bed sores.

* Phase III study.

Venous Leg Ulcers*

Average time to complete healing

  • Test group REGEN-D® 150 : ~40days.
  • Control group : ~95days.

Efficacy of REGEN-D® 150

Adapted from Phase III Clinical Trial in Chronic Leg Ulcer.

*Phase III study.

Long-term Surveillance Study for Safety

  • A 2-year follow-up study was conducted to assess the long-term safety of REGEN-D® 150 in all subjects enrolled in this Phase III clinical trial.1,2
  • No incidents of recurrence of ulcers from the subjects using REGEN-D® 150 post-study period.2
  • None of the subjects observed a detection of premalignant or malignant lesion.
  • The surveillance established no complaints from the subjects regarding the use of REGEN-D® 150 proving its clinical safety & efficacy in accelerating healing of DFUs.2

References:

  1. Viswanathan V. A phase III study to evaluate the safety and efficacy of recombinant human epidermal growth factor (Regen-D 150) in healing diabetic foot ulcers. WOUNDS. 2006;18(7):186–196.
  2. Mohan VK. Recombinant human epidermal growth factor (REGEN-D™ 150): Effect on healing of diabetic foot ulcers. Diabetes Res ClinPract. 2007;78(3):405-411.

Abridged Prescribing Information

Composition: Each gram of gel contains Recombinant Human Epidermal Growth Factor 150 μg. Indications: REGEN-D®150 is indicated for the use of 1. Diabetic Foot Ulcers, 2.Bedsores, 3. Chronic Venous Ulcer. Contraindications: REGEN-D® 150 is generally well tolerated. However, the product should not be repeatedly given to persons known to be hypersensitive to any of the components of the product. The product is contraindicated with immunosuppressive or immune-stimulant therapy. Dosage & administration: After cleaning the ulcer area, apply the gel so as to cover the entire ulcer area. Dosage of the gel depends on the specific size of the ulcer & it should as per physician’s advice. REGEN-D® 150 is in the form of a gel. It is to be spread evenly (topical application) on the affected part with a sterile cotton swab, twice a day, until the ulcer heals completely. Precautions: It is suggested that the medical practitioners ascertain the hypersensitivity status of the subject. REGEN-D® 150 therapy should be continued up to a period of 15 to 20 weeks. The continuation of the therapy is at the discretion of the physician. Adverse reactions: REGEN-D® 150 has proven low reactogenicity & is well tolerated in humans. Clinical trials so far, have not shown any adverse reactions to human subjects. Clinical data: A Phase III, double blind, randomized, placebo controlled, parallel study was conducted to evaluate the safety & efficacy of REGEN-D® 150 in diabetic foot ulcers, chronic leg ulcers (venous ulcers) & bed sores (Pressure ulcers). In all of the conditions mentioned, the healing time was less in REGEN-D® 150 group compared to the placebo. A Phase IV, double blind, randomized, placebo controlled, parallel study was conducted to evaluate safety & efficacy of REGEN-D® 150 in diabetic foot ulcers compared to reference group & the results found REGEN-D® 150 to be safe & tolerable. Pharmacodynamic properties: Activation of EGFR leads to a number of biological responses, including migration, proliferation, cryoprotection, cellular differentiation, & apoptosis.1 In wound healing EGFR plays an important role in re-epithelialization & dermal maturation.2 Topical use of recombinant human EGF has been shown to increase re-epithelialization & enhance wound healing. Storage & stability: Store at room temperature (250C). 1. Bodnar RJ. Epidermal growth factor & epidermal growth factor receptor: The yin & yang in the treatment of cutaneous wounds & cancer. Adv Wound Care (New Rochelle). 2013;2(1):24–29. 2. Tokumaru S. Ectodomain shedding of epidermal growth factor receptor ligands is required for keratinocyte migration in cutaneous wound healing. J Cell Biol. 2000;151(2):209-20.

REGEN-D® 150  is a registered trademark of Bharat Biotech. Manufactured by: Bharat Biotech. Marketed by: Anamay Biotech.
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