Since I last wrote about Access Pharma (OTCQB:ACCP-OLD) two weeks ago as a cancer biotech call option trade, the Company has issued two updates on its clinical development pipeline and two updates for MuGard – which is an oral rinse product for the management of a common side effect of many cancer therapies, mucositis. In late May, Access announced that MuGard was launched in Germany, Italy, UK, Greece, and the Nordic countries by its European commercial partner, SpePharm, with expected launches in North America, Asia, and other regions slated for later this year.
On 6/10/09, ACCP.OB also announced that the Company received issue notifications from the United States Patent and Trademark Office for two US patents (numbers 7,544,348 and 7,547,433).
On 6/4/09, ACCP announced that new thiarabine preclinical data will be published shortly in the journal "Cancer Chemotherapy and Pharmacology" which demonstrates that thiarabine combined with clofarabine provides much greater anti-tumor activity than achieved by either agent used alone (e.g. in one colorectal cancer model, 66% of mice were cured of their tumors). The publication is based on work conducted by the Company’s collaborators at the Southern Research Institute, and the paper is entitled "Enhancement of the in vivo antitumor activity of clofarabine by 1-beta-D-[4-thio-arabi... (thiarabine).
President and CEO, Jeffrey Davis, stated that,
Thiarabine has been in two Phase 1/2 solid tumor trials and was shown to have significant anti-tumor activity. Access is working with leukemia and lymphoma specialists at M.D. Anderson Cancer Center in Houston to initiate additional Phase 2 clinical trials in acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and other indications. Additionally, we are actively seeking co-development partners, and believe that thiarabine could have applications in certain solid tumors as well.
On 6/1/09, Access provided an update on its clinical development plan for ProLindac, which is a novel DACH platinum drug that has shown to be active in many solid tumor types in human clinical studies. The Company recently announced positive safety and efficacy results from its Phase 2 mono-therapy clinical study of ProLindac in late-stage, heavily pretreated patients with ovarian cancer. In this study, 66% of patients who received the highest dose achieved clinically meaningful disease stabilization according to RECIST criteria. No patient in any dose group exhibited any signs of acute neurotoxicity, which is a major adverse side-effect of the approved DACH platinum, Eloxatin, and ProLindac was well tolerated overall.
ACCP has scaled-up manufacturing in order to begin the next phase of clinical development for Prolindac and the Company plans to conduct several combination trials in different solid tumor types both as Company-sponsored trials and in conjunction with its two previously announced co-development partners. Access is currently in discussion with potential North American and European partners for co-development of ProLindac while the Company is working with its existing partners in Asia to design and manage new clinical trials for the compound.
Since I first wrote about Access in early May
and compared the Company to Cell Therapeutics (NASDAQ:CTIC
), the average volume and share price have made steady progress with increases of about 100% and 50%, respectively, as the small and micro-cap bio-pharma space is currently very popular with investors and traders. Even with the increase in share price, ACCP trades at a fully diluted market cap of just $48M at the closing price of $2.20 today, accounting for 11.3M shares outstanding and 10.6M shares of common stock convertible under preferred shares (even though this is not reflected by financial data providers such as Yahoo and Google Finance).
ACCP projects that it will have sufficient liquidity to fund operations at the current level (net cash burn rate for 1Q09 was $0.5M) through 1Q10 based on its current cash/equivalents ($2.2M at the end of 1Q09) and expected upfront, royalty, and milestone payments. At the end of 1Q09, ACCP we had convertible note outstanding in the principle amount of $5.5M that is due 9/13/11. During 2H09, Access plans to start multiple clinical trials for ProLindac and thiarabine, in addition to selling off its anti-infective dermatology assets (EcoNail, Pexiganan), which could provide additional upside catalysts for the stock price and cash to fund the continued development of the Company’s pipeline.
Disclosure: Long ACCP.