Misopess™ Vaginal Insert

The Misopess vaginal insert uses the same vaginal delivery system as Cervidil/Propess but with a different active ingredient, misoprostol. Misoprostol, a synthetic PGE1 analogue, is approved as a cytoprotective agent in combination with nonsteroidal anti-inflammatory drugs, but is frequently used “off-label” for cervical ripening. Misoprostol has activity on both the cervix and the uterus and may serve both to ripen the cervix and augment labor. As such, the Misopess vaginal insert may function as a one-step labor induction agent.

CPSI licensed rights to Misopess in Korea to Hyundai Pharmaceuticals in 2006. The Company is currently looking for licensing partners in the rest of the world.

Semapimod (formerly known as CNI-1493)

Semapimod is a synthetic guanylhydrazone that inhibits: (i) signal transduction pathways by preventing phosphorylation of MEK, p38 MAP kinase and JNK; (ii) production of the proinflammatory cytokines TNF-alpha, IL-1, IL-6. MIP-1 alpha, MIP-1 beta; and (iii) production of nitric oxide. These signal transduction pathways and proinflammatory molecules are known to be active in various inflammatory and autoimmune diseases. Semapimod may therefore have widespread applications in these diseases. In animal models semapimod has shown protective activity against a wide variety of conditions, ranging from stroke to inflammatory bowel disease. Clinical studies have shown activity in several disease conditions (e.g., psoriasis, Crohn's disease, ERCP-induced pancreatitis). A new salt form of semapimod has demonstrated oral efficacy in animal models. CPSI is seeking licensing partners for semapimod in various indications and territories.

Pilobuc™ Buccal Insert for Xerostomia

Also using CPSI’s proprietary hydrogel polymer, the Pilobuc™ buccal insert releases pilocarpine into the mouth over a period of several hours. Pilocarpine is a cholinergic agent that stimulates saliva production. Pilobuc is being developed to treat xerostomia (dry mouth) associated with Sjögren’s syndrome and radiotherapy for head and neck cancer. Sjögren’s syndrome is an autoimmune disorder characterized by the chronic loss of tear and salivary gland function. Xerostomia may also result from damage to the salivary glands caused by radiation therapy for head and neck cancer.

Currently available treatments are of short duration and can cause unpleasant side effects, including excessive sweating, nausea, flushing and urinary frequency. It is expected that Pilobuc’s sustained buccal delivery will reduce these side effects while providing longer relief of dry mouth symptoms.

CPSI has licensed rights to Pilobuc to Marillion Pharmaceuticals.

C-Vad™ Vaginal Insert for Bacterial Vaginosis

CPSI is also developing the C-Vad controlled-release vaginal insert to treat bacterial vaginosis. Bacterial vaginosis is one of the three most common vaginal infections in women. It is usually caused by an imbalance of the normally existing microorganisms living in the vagina. It may cause vaginal discharge and an unpleasant odor. Recent studies also suggest that bacterial vaginosis may be implicated in some cases of pre-term labor.

The C-Vad vaginal insert delivers a measured amount of the antibiotic clindamycin over a 12-hour period. Clindamycin is currently used for the treatment of bacterial vaginosis in cream, ovule and oral formulations. Each of these formulations has drawbacks: oral clindamycin often causes significant side effects, while the vaginal cream and ovule formulations may leak out, resulting in discomfort, embarrassment and underdosing. CPSI’s vaginal delivery system reduces systemic exposure and, therefore, side effects. It also delivers the drug in a precise dose, without the messiness of a cream or ovule.

CPSI is seeking licensing partners for C-Vad in the US and the rest of the world.

Fibrovax™ Cancer Vaccine

Fibrovax is an autologous cancer vaccine based upon fibrocytes, a novel class of antigen-presenting cells in the blood discovered at The Picower Institute for Medical Research. The vaccine uses fibrocytes harvested from a cancer patient’s blood which are then cultured and, once sufficient quantities have been produced, exposed to lysates from the patient’s cancer cells. This exposure is designed to couple the fibrocytes with antigens from the tumor for presentation to the patient’s immune system. The exposed fibrocytes are then reinfused into the patient to produce a specific immune response against the tumor.

A Phase I study has been completed demonstrating the safety of Fibrovax. However, because of the higher priority of other development programs and the projected cost of Fibrovax clinical trials, CPSI is seeking to license out this technology to a third party or parties for further development.