Hot watch list for biotech microcap

SPEX (buy)

"Spherix Incorporated, together with its subsidiaries, operates as a scientific research company. It is developing D-tagatose that is in Phase 3 clinical trial for the treatment of type 2 diabetes.

Biospherics’ lead clinical candidate is D-Tagatose, a naturally occurring simple sugar being developed as an oral treatment for glycemic control in patients with Type 2 diabetes and other indications. D-Tagatose has been recognized by the U.S. Food and Drug Administration (FDA) as a GRAS (Generally Recognized as Safe) substance for use in food and beverages since 2001.

Structurally, D-Tagatose is a naturally occurring stereoisomer of D-fructose, and resulted from the application of Biospherics’ expertise in chiral carbohydrate chemistry to create L-sugars that would retain their sweetness characteristics without being metabolized. Originally developed as a reduced-calorie sugar substitute, D-Tagatose is poorly absorbed in the small intestine, thus preventing the stimulation of insulin secretion and lowering blood glucose levels. D-Tagatose passes directly to the lower intestine, where it is fermented by bacteria to produce short-chain fatty acids and carbon dioxide. It is considered a prebiotic, promoting more favorable microbial flora in the colon.

D-Tagatose is currently being studied as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 diabetes in a double-blind, randomized Phase 3 study at 62 sites in the U.S. and India. The study is powered to detect a 0.5% reduction in HbA1c as its primary endpoint, with secondary endpoints establishing glucose, insulin and lipid profiles and measuring changes in body weight.

Spherix has intellectual property protecting D-Tagatose, with 2 issued U.S. patents and one patent pending. In addition, if approved, D-Tagatose is likely to receive at least five years of market exclusivity as a result of the Hatch-Waxman extension for new chemical entities."

Biospherics is running a Phase 2 clinical trial studying the dose-response effect of minimal doses of D-Tagatose on glycemic control in subjects with Type 2 diabetes under diet control and exercise. It is a six-month, multi-center, single-blinded, randomized parallel study. Preliminary results of the trial were encouraging, with the group receiving 7.5 grams of D-Tagatose averaging a 0.3% reduction in HbA1c (blood glucose level) versus the group receiving 2.5 grams, and the group receiving 5.0 grams of D-Tagatose averaging a reduction in HbA1c of 0.05% versus the 2.5 gram group. In addition, triglycerides (a measurement of fat in the bloodstream) were reduced by 59 mg/dl, low-density lipoproteins (LDL, or “bad” cholesterol) were lowered an average of 13 mg/dl and high-density lipoproteins (HDL or “good” cholesterol) were raised an average of 0.9 mg/dl. The overall LDL:HDL ratio of the subjects in the trial improved by 0.3.

Very good preliminary HbA1c results for 7.5 g dose: 0.3% reduction.

In phase III trial they are using higher dose: Tagatose powder; 15 grams three times daily; one year

Trial Inclusion Criteria:

* Type 2 diabetics in accordance with WHO.
* Male and female patients, between 18 and 75 years of age.
* Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise.
* Normal blood creatine clearance and normal liver function test results.
* BMI less than or equal to 45kg/m2.

So, primary point to reduce HbA1c 0.5% seems achievable.

SPEX product is simple and very safe (even GRAS). If D-Tagatose decrease HbA1c it will be prescribed to millions Type 2 diabetes patients in USA. I especially like this because it "retain their sweetness characteristics without being metabolized." May be it will be a good idea to make D-Tagatose 
over-the-counter (OTC) drug so everybody can buy it and use instead of sugar (like Stevia).

It is testing in phase II and phase III efficacy trials.
Estimated Study Completion Date: December 2010

Today news induced pps drop and created a perfect opportunity to buy SPEX at deep.

Disclosure: I opened SPEX position today. Medium risk, high reward.

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