Biotech Investing

The company’s announcement points to a larger trend towards biotech innovation in the San Diego area.

Clinical-stage biopharmaceutical company HedgePath Pharmaceuticals (OTCMKTS:HPPI) said last Friday that it is starting a Phase II(b) trial for SCORING (SUBA-Cap Objective Response in Gorlin’s), its proposed cancer treatment.
The clinical trial will test the safety and efficacy of twice-daily dosing of SUBA-Itraconazole oral capsules, which are intended as a therapy for basal cell carcinoma (BCC) in patients with basal cell carcinoma nevus syndrome (BCCNS), commonly known as Gorlin’s Syndrome. The announcement of the clinical trial sent the company’s share price up to $0.13, an 18.18-percent rise.

Launch of clinical trial

BCCNS stems from a genetic mutation that causes improper functioning in the Hedgehog pathway, a major regulator of cellular processing. Approximately 10,000 Americans suffer from the condition, which leads to the chronic formation of basal cell tumors.
HedgePath’s clinical trial is aimed at testing the objective response rate of BCC lesions to SUBA-Itraconazole in patients suffering from BCCNS. Commenting positively on its launch, the company’s president and CEO, Nicholas Virca, stated, “we are extremely pleased and enthused to launch our first clinical trial as a single arm, Phase II(b), multi-center, open-label, non-placebo-controlled study for which we plan to recruit up to 40 patients across three clinical trial sites in the US. Based on our enrollment objectives and the first phase of our study plan, we expect to be able to assess interim results in over half of these patients during the first quarter next year.”
HedgePath anticipates that the clinical trial will reveal that SUBA-Itraconazole oral capsules have substantial statistical benefits for patients with BCCNS. A “meaningful response” would see target tumors be reduced in 33 out of 40 clinical trial patients by 30 percent. Should the clinical trial be successful, the company will likely use it to gain FDA approval of SUBA-Itraconazole oral capsules as a product candidate.

Region of innovation

HedgePath’s decision to pursue a clinical trial for SCORING speaks to a broader trend towards biotech innovation in the San Diego region. For example, Synthorx announced advances to its synthetic DNA technology last week, employing a proprietary protein expression system to create novel amino acids. Genalyte also had good news, announcing a $44-million funding round to support its development of a diagnostics system that reduces the time between getting a blood test and receiving results.
Together, these announcements suggest that San Diego is a promising region for investors to watch, as more companies, both public and private, come out with exciting news in the biotech field.

Securities Disclosure: I, Morag McGreevey, hold no direct investment interest in any company mentioned in this article.

Related reading:

Top Biotech and Pharma M&A of Q1 2015
Biotech’s Hot Streak Continues with Aimmune IPO

NantKwest’s Record-breaking $2.6-billion IPO Valuation
Biogen’s Share Price Drop May Provide Opportunity for Investors
2014 Best-performing Biotech Stocks


S&P 5003911.74+116.01


Heating Oil4.24+0.02
Natural Gas6.17-0.07