Novelos: Revival of a Troubled Cancer Drug (NVLT)
BioHealthInvestor.com is not generally in the business of featuring OTC-BB or Pink Sheet stocks due to the risks and the inherent implosions and scams that have been seen left and right through time out of OTC-BB and Pink Sheet companies. Yet sometimes, exceptions need to made… with severe caveats, of course.
Novelos Therapeutics, Inc. (OTC-BB: NVLT) is a biotechnology firm which has suffered a form of its own private Idaho before. News out of the company this morning has rekindled at least some interest in a name that we had all but written off for dead.
Novelos saw shares imploded earlier this year after its promising lung cancer drug development program for NOV-002 failed in a late stage trial against lung cancer. In fact, this was a $2.00 stock at the start of this year and had drifted down to $1.65 before the news implosion came out. Shares then fell to about $0.30 overnight and then eventually slid to the recent levels around $0.10.
This morning the company announced positive phase 2 results for NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with certain types of breast cancer (stage IIB-IIIC HER-2/neu negative invasive breast cancer). Same drug candidate, different indication.
The company said that its criterion of 12 pathologic complete responses has been met prior to all patients completing the trial. Results from this study now has 39 breast cancer patients who have been enrolled from three different hospitals, and the company noted that it has its 12 confirmed pathologic complete responses out of 31 patients who have undergone surgery. This is higher than what had been previously been reported with preoperative chemotherapy. ”
The goal is to show that the addition of NOV-002 doubles the complete response rate for breast cancer patients taking three other chemo drugs. The number of successful PCRs may also rise as some of these 39 patients already in the study are still being treated and will need to be evaluated for scores.
This was a single-arm study, so it did not have a side-group of patients that were receiving placebo. That may make any ultimate FDA action down the road more challenging, but that is also something that may be months or years down the road. The company said it does plan to seek FDA guidance on designing a larger placebo-controlled study.
Today’s news is merely a rekindled “proof of concept” rather than an outright win or anything that would signal an assured FDA approval. Still, this brings NOV-002 back from what investors and the public had written off as a dead issue.
Shares are up over 10%, on a rounded basis and the stock is still only listed as being at $0.13 on the OTC-BB. The 52-week range was $0.09 to $3.05, meaning the expectations here were slim or none. The market cap is a mare $11.5 million after the pop.
While it had $5.612 million in cash and equivalents on its books at the end of last quarter, the company also listed $5.866 million as its accounts payable and listed another $392,000 in its deferred long term liability charges on the books.
Novelos is probably far from coming back to life with a vengeance, but it may have just gotten one foot out of the grave.
JON C. OGG
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