Bio-Path continues to Make Progress

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Bio-Path continues to Make Progress

Grant Zeng, CFA

Shares Commence Trading on OTCQX

Bio-Path Holdings, Inc. (BPTH) shares began trading on the quality-controlled OTCQX on Friday, June 1, 2012.

OTCQX is the highest tier, premier trading platform for OTC companies. The trading on OTCQX means that Bio-Path is qualified for the OTCQX’s high standards. The Company also announced that it has retained Roth Capital Partners to serve as the Company’s Designated Advisor for Disclosure (:DAD) on OTCQX, responsible for providing guidance on OTCQX requirements.

OTC Markets has 3 tiers: OTCQX, OTCQB and OTC Pink. OTCQX is the top tier of the OTC market. Exclusively for companies that meet the highest financial standards and undergo a qualitative review.

Investor-focused companies use the quality-controlled OTCQX platform to offer investor transparent trading, superior information and easy access through their regulated U.S. broker-dealers. The OTCQX platform offers companies and their shareholders a level of marketplace services formerly available only on a U.S. exchange.

Bio-Path’s commencement of trading on the OTCQX attests to the quality of the Company’s financial reporting and its technology.

Current focus is Antisense Technology

Bio-Path recently abandoned its RNAi program Liposomal FAK (L-FAK, BP-100-2.01) due to unfavorable market environment. Right now, the Company is focused on its lead antisense program Liposomal Grb-2.

Phase I of Liposomal Grb-2 Is Progressing Well

On May 29, Bio-Path completed treatment of the third dosage cohort in its Phase I clinical trial of Liposomal Grb-2, which is a systemic treatment for blood cancers, including acute myeloid leukemia (:AML), chronic myelogenous leukemia (:CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (:MDS).

The Phase I trial is being conducted at the MD Anderson Cancer Center. The drug’s safety profile continues to be favorable, with no treatment-related serious adverse events reported, and data continues to suggest some possible anti-leukemia activity.

A total of three patients were enrolled and dosed in the third cohort of the study. All three patients completed the 28-day treatment cycle and were evaluable. Liposomal Grb-2 is systemically delivered by intravenous injection. Patients received a dose of 20 mg/m2 twice a week for four weeks, for a total of eight doses. Preliminary results suggest that Liposomal Grb-2, at a dose of 20 mg/m2 is well tolerated. The protocol for the clinical trial includes dose escalation of 5, 10, 20, 40 and 50 mg/m2. The expected dose for treatment is 45 mg/m2 based on pre-clinical studies in animals.

There continued to be a suggestion of possible anti-leukemia activity, as all three patients stabilized. As such, all three patients are receiving or will receive additional treatment cycles. In the protocol of the clinical trial, a patient exhibits stable disease if, in the opinion of the principal investigator, there is no clinically significant change in the disease. One patient, from this cohort, with AML had bone marrow blasts reduced by 60 percent during the first treatment cycle to within normal parameters and continued with a second treatment cycle.

Bio-Path is making significant improvement for each cohort in terms of time for completion of a cohort, number of patients enrolled and the percentage of evaluable patients that received extended treatments as the below table shows. An important measure of benefit from treatment with the drug is stabilization and being placed on extended treatment cycles. This trend is also very positive, with all three patients from cohort 3 being placed on extended treatment plans.

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It is clear that the momentum of the trial has significantly changed to the better, with markedly shortened times to complete a cohort and the minimum number of patients needed. The increase in the number of patients needing drugs for extended treatments has caused Bio-Path to accelerate its plans to upgrade the capacity of drug supply chain. New supplies will become available to continue treatment of patients in June.

The fourth cohort is ready to be opened for enrollment once the new drug supplies have arrived, as well as the continued treatment of third cohort patients on extended treatment plans.

We think the interim results from the first two cohorts are encouraging. The suggestion of possible anti-leukemia activity with the low doses used in the first and second cohorts is especially impressive.
 

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