What is the critical gap in cancer treatment that you are addressing?
Colorectal cancer (CRC) is the third most common cancer in both men and women in the United States. Most cases of CRC are diagnosed at early/mid stage, when the cancer is localized and confined to the colon and lymph nodes. Unfortunately, the recommended treatment for almost all early to mid stage CRC is surgery (i.e. laparoscopic and open colorectal) to remove polyps, cancer growths, the lymph nodes and the nearby healthy colon. This is sometimes followed by chemotherapy. While colorectal surgery has been deemed “curative,” many patients experience a combination of physical and emotional problems for a long period of time after surgery. Symptoms such as fatigue, pain and disturbed bowel function, as well as problems in social and role functioning, inevitably affect the patients’ wellbeing. There is a clear need for better CRC treatments that work AND address postoperative quality of life issues.
Siva’s Therapeutics is a Austin,Texas based biotech dedicated to developing a thermal cancer therapy called “Targeted Hyperthermia™.” Siva’s main product in development can provide a valuable tool for early intervention without the risks of surgery or drugs. This creates an opportunity to use Targeted Hyperthermia™ on an outpatient basis for the treatment CRC. If widely implemented, Targeted Hyperthermia™ could be a desired alternative to the current surgical practices for treating early to mid stage CRC.
What is Targeted Hyperthermia™? It is a minimally invasive procedure that involves the systemic injection of precision polymer-coated gold nanorods (called SivaRods™) and the use of an infrared light device (SivaLum™) coupled to a flexible endoscope. CRC patients will go to the clinic for an injection of SivaRods™ and return 12-18 hours later for a 10-minute treatment with infrared light using a SivaLum™ light device in a flexible sigmoidoscopy procedure. The injected SivaRods™ concentrate in tumors due to the “leakiness” of tumor vasculature, and they absorb infrared light and convert it into heat very efficiently, resulting in therapeutic heat (111°F/44°C) that emanates from within tumors and ultimately kills them. SivaRods™ are very safe and non-toxic, and they are excreted from the body within 2 weeks after administration. Pre-clinical studies indicate that one injection of SivaRods, and one treatment with infrared light will dramatically improve patient outcomes and reduce the need for surgery and drug therapy.
What is the key product development milestone you seek to fund?
As Siva’s Targeted Hyperthermia™ moves closer to initial human clinical studies, a key element of product development will be to create awareness of the benefits of this valuable new cancer therapy. Because of this, we are seeking funding for an outreach coordinator who will share the benefits of our Targeted Hyperthermia™ approach to physicians, providers, payers, patients and patient advocacy groups. Awareness of new cancer treatments is an essential, and sometimes underrecognized, part of the product development cycle, and the funds raised from this campaign will enable Siva to address this need.
How will funds be used?
Our fundraising goal is $70,000 for the first year. We intend to use these funds to hire an outreach coordinator position; if more than this is raised, the additional funds will be used to support and extend the position. The hired coordinator will raise awareness on the benefits of Targeted Hyperthermia™ with patients and patient advocate groups, physicians, providers, and payers as we enter the clinic.
What key resources have/will you acquire to facilitate the accomplishment of the above product development milestone?
Siva is actively raising $2.1 million, with over $400,000 closed, to fund completion of preclinical work and to gain clearance to begin human clinical studies. We are optimistic that we will close this round in Q1, 2022, and move forward. Key resources for preclinical studies and preparation for clinical studies will be: 1) manufacture of a supply of SivaRods™ gold nanorods and 2) development of a second generation SivaLum™ light engine. Finally, we plan to hire key personnel to support this work.
Funds from our campaign will provide a powerful message and leverage for patient advocacy groups for CRC, some of which we have already been in touch with. Growing the awareness of the potential for safe, effective hyperthermia treatment for cancer by patients and patient advocacy groups will accelerate the acceptance of these valuable tools for mainstream use. The CRC community, in particular, is asking for better treatments, and we plan to provide an important first step in that direction.
If your Technology were to disappear in the “Valley of Death” funding bottleneck how might this impact society?
Targeted Hyperthermia™ is a new approach to cancer therapy that could complement other cancer therapies already in use and offer better patient experience and quality of life outcomes. For CRC patients diagnosed with early to mid stage disease, Targeted Hyperthermia™, if widely available, could drastically improve treatment outcomes. Should this technology fail to reach patients who could benefit, cancer treatment as we know it would continue to burden the quality of life for individuals and society. At Siva Therapeutics, we intend to change this.