The biggest strategic driver for CUI remains the potential for the GasPT product to...
Harnessing Sulforaphane's Therapeutic Properties
Sulforaphane, a natural compound first isolated from a precursor in Brassica plants, has shown therapeutic potential, but has also proven too unstable to be manufactured as a drug on commercial scale.
Evgen Pharma (LON:EVG) has developed a proprietary technology - Sulforadex® - that allows the synthesis of sulforaphane in the form of a stable, solid powder that can be easily manufactured as an oral drug.
The Company has then developed several analogues with slightly different biophysical properties that could reveal beneficial effects in specific therapeutic indications, and reinforce their IP estate.
Evgen's lead drug, SFX-01, is a patented combination of synthetic sulforaphane and alpha-cyclodextrin (as a stabilising complex).
Figure 1: SFX-01 stability data (source: Company data)
Figure 2: Sulforaphane mechanism of action (source: Company data)
No safety or tolerance issues related to SFX-01 have emerged in the clinical studies conducted thus far.
Sulforaphane has shown the ability to inhibit the proliferation of breast cancer stem cells that often "escape" the action of hormonal therapy and play a key role in disease progression.
Recent studies suggested that SFX-01 anti-cancer effect is mediated via the STAT-3 pathway, which plays an important role in cancer stem cells proliferation. Animal models have also shown that SFX-01 significantly reduces the formation of micro-metastasis in the lungs (Figure 3).
Figure 3: In combination with Tamoxifen or Fulvestrant, SFX-01 reduces micro-metastases in the lungs (source: Company data)
A 60-patient, open label, Phase 2 clinical trial is testing SFX-01 in breast cancer patients with an estrogen receptor (ER) positive, HER2 negative, metastatic breast cancer that has become unresponsive to aromatase inhibitors, tamoxifen or fulvestrant.
SFX-01 is administered for up to 6 months during the trial in which both safety and efficacy of the treatment will be assessed. Interim data should be available in the first-half of 2018, with final data to be released around the year-end. Some patients have entered a compassionate use programme after showing either stable or shrinking tumours over the maximum 6 month trial period.
We believe that positive interim data may provide the basis for exploring out-licensing opportunities for the further development of SFX-01 in breast cancer.
In the US alone breast cancer causes over 40,000 deaths every year. About 75% of cases are classified as ER+ and Arimidex, a drug developed by AstraZeneca for this patients' subgroup, achieved about $1.9bn global sales before generic competition entered the market. The global breast cancer market is currently worth over $13bn.
Subarachnoid haemorrhage is a severe condition involving bleeding in the outer part of the brain (the subarachnoid space). It is fatal in 50% of cases and the acute episode is often followed by delayed cerebral ischemia within 3-14 days, leading to significant morbidity in about 50% of the survivors.
The only approved treatment is based on nimodipine, a generic calcium-channel blocker that however only provides limited clinical benefits.
Pre-clinical in-vivo studies suggest that SFX-01 reduces inflammation and neurological deficits, largely via the up-regulation of the Nrf2 pathway.
A 90-patient, double-blinded, Phase 2 study is in progress in the UK; headline results are expected around the end of 2018. Following the successful completion of this Phase 2 study, a subsequent pivotal trial would need to enrol about 250 - 300 patients.
There are approximately 30,000 SAH cases in the US every year, and Evgen has received orphan drug designation in this indication. This will speed up the development and regulatory process, and provide multi-year market exclusivity.
To further explore SFX-01’s therapeutic potential, Evgen has initiated a number of collaborations with leading universities, including King's College London and the Mayo Clinic.
These collaborations are looking at SFX-01’s therapeutic potential in several indications, such as stroke, brain cancer and osteoarthritis.
Evgen had a cash balance of £2.2mln as of the end of September 2017, and subsequently raised approximately £2.1mln (net of fees) via a rights issue in December 2017.
This should provide the Company with sufficient resources to support operations and fund the two ongoing Phase 2 clinical studies until completion, expected around the end of 2018.
The next rights issue should take place after the release of the interim data from the breast cancer trial, which would likely support the stock's valuation.
Finally, we would expect that positive results from the two lead programs in SAH and breast cancer will trigger licensing and/or M&A activity.
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