What is Chemotherapy-Induced Alopecia(CIA)?

Hair loss (Alopecia) associated with chemotherapy and other cancer treatments is one of the adverse effects most commonly associated with cancer treatment.

• CIA is one of the most common side effects resulting from chemotherapy use in patients suffering from cancer.
• It is characterized by hair loss either in the scalp or over the whole body.
• It affects both genders. However, women more often experience widely spaced alopecia.

When does CIA occur?

• CIA begins 1-2 weeks after the 1st treatment and is complete by the 2nd chemotherapy cycle.
• Chemotherapy lasts on average 4-6 months and regrowth starts 1 to 6 months after last treatment.
• Results in the absence of hair for up to 12 months, and two years for normal hair.
  Rare cases of permanent alopecia have been observed in patients who had little or no regrowth after 6 months.

What causes CIA?

• CIA pathophysiology is not fully known, and it depends on the MoA of each cytotoxic agent.
• Chemotherapeutic agents impair mitotic and metabolic process of rapidly dividing cells leading cancer cells and hair follicles to an apoptotic stage.
• All chemotherapeutic agents do not have the same effect on hair follicles.

Clinical Trial

BPGbio (BERG) has completed a Phase 1 Trial. We are looking forward to advancing to the next phases of clinical development.

How does BPGbio’s (BERG) BPM 31543 for Chemotherapy-Induced Alopecia (CIA) treatment work?

BPGbio’s (BERG) BPM 31543 is a topical calcitriol formulation in clinical development for the prevention and treatment of Chemotherapy-Induced Alopecia.

The incidence of CIA within chemotherapy regimens is high: 65% of patients receiving chemotherapy develop CIA, with figures reaching as high as 80-100% with agents such as paclitaxel or doxorubicin regimens.

BPGbio’s (BERG) BPM 31543 calcitriol formulation influences the expression of genes regulating hair growth and impacts a key regulatory event in conferring protection against the effects of chemotherapy responsible for inducing hair loss. The delivery of the drug using a proprietary formulation has been associated with a potential signal of efficacy at all doses tested. BPGbio’s (BERG) BPM 31543 has undergone a Phase 1 clinical trial in which the safety and tolerability have been established.

Efforts are currently focused on late-stage clinical trials for product registration and approval.

BPGbio’s (BERG) BPM 31543 success factors: no MTD or TLD, no drug interaction with chemotherapeutic agents, recognized efficacy in preventing CIA and ease of use for patient compliance.

Medical Guidelines

• BPGbio’s (BERG) BPM 31543 is the first Pharmaceutical solution for a disease that has no clinical management or guidelines.

Patient Friendly

• BPGbio’s (BERG) BPM 31543 is a topical treatment that can be applied by the patient at home.
• It is a Topical RX drug that is convenient to use in the privacy of home.

Accessibility

• BPGbio’s (BERG) BPM 31543 is accessible to every patient.
• No need for costly medical devices.
• No limitation to the number of patients that can use the product.

Effective and Safe

• BPGbio’s (BERG) BPM 31543 has shown initial POC for hair loss prevention by stopping the anagen phase of the hair follicle.
• No interaction with chemotherapy drugs
• No toxicity recorded
• No Limiting dose