|Developing|
|Novel|Proprietary|Prescription Drugs|
|From Botanicals|
Reducing Morbidity & Mortality
Through Supportive Care for Serious Diseases like Cancer
Unmatched Value Proposition
Just about 5 Years to Market
Just about $10M to NDA
Extremely Minimal Chance of Failure
2258
Fractional Pre-Clinical Requirements
And That’s A Big Deal!
A new botanical drug (containing multiple chemical constituents) may qualify as a new chemical entity under § 314.108(a) and be
eligible for 5 years marketing exclusivity
FDA’s Pragmatic IND Pathway for Botanicals
“Totality of Evidence Approach”
“it is desirable to facilitate the development of natural source products that have been used in humans” “to apply regulatory policies that differ from those applied to nonbotanical drugs“
AD-OM1 for
Oncotherapy Induced Oral Mucositis
Acute & debilitating morbidity - OM one of the prime limiting factors of chemo-radiation therapy for advanced H&N carcinoma
Delays cancer treatment plans, interruptions and discontinuation - leading to diminished, sub-optimal anti-tumor responses & shorter survival
Marked Deterioration in Quality of Life: Healing Takes Weeks to Months
Poor Oral Ingestion Necessitates Parenteral Nutrition
Higher risk of systemic infections, increased use of antifungals & opioids
More frequent & longer hospitalization: Upto $17,000 incremental costs
​
Current management of OM includes oral cryotherapy, IV Keratinocyte growth factor-1, intra-oral low-level laser therapy, prostaglandins, Amifostine, anti-cholinergics, benzydamine mouthwash, topical barrier gels (without drugs).
Local anesthetics provide non-lasting relief with risk of injury.
Partial relief comes with significant, debilitating adverse effects.
Well documented powerful anti-inflammatory action
Action against pathobiology of MO at all phases of pathogenesis
Enhances mitosis and multiplication of cells Expected to facilitate lesion closure, renewal of the epithelial cell proliferation and differentiation ​
Acts on coagulation pathway for efficient wound closure​
Bio-adhesive muco-protective mechanical barrier gel formulation
Facilitating protection & moisture-retention on oral mucosa
No known drug interactions or side effects
No adverse effect likely upon swallowing
Orphan designation expected
Phase II Clinical Trial
beginning Q4 ’25
for Chemo & Radiotherapy Induced Oral Mucositis
Immense Potential for Label Expansionto management of mouth cancer, erythroplakia, leukoplakia,oral surgeries & aphthous
AD-NV1 for
Oncotherapy Induced Nausea & Vomiting
Serious, highly distressing & debilitating condition
Nausea first or second most severe side effect, marked deterioration of QoL
Leads to anorexia, metabolic imbalance, nutritional deficiency,
wound dehiscence, esophageal tears
Causes cancer treatment delays, interruptions and discontinuation - leading to sub-optimal response to therapy and diminished survival rates
Current management of NV includes Serotonin receptor antagonists (e.g., Ondensetron, Granisetron), Olanzapine, Substance P / Neurokinin-1 (NK1) receptor antagonists (e.g. Aprepitant, Rolapitant), Corticosteroids (e.g., Dexamethasone), Dopamine receptor blockers (e.g., Metoclopramide), Antihistamines (e.g., Meclizine).
Partial relief comes with significant adverse effects.
Well documented powerful anti-emetic action
Success expected against acute, delayed, anticipatory, breakthrough as well as refractory nausea & vomiting
Initial studies as adjunct therapy with potential as safe first-line prophylactic as well as continuous use throughout risk period
Multiple mechanisms of action including powerful 5-HT3 receptor antagonism
Very minor adverse effects & drug interactions, if any
Phase II Clinical Trial
beginning Q4 ’25
for Chemo & Radiotherapy Induced Nausea & Vomiting
Orphan designation expected