<SEC-DOCUMENT>0001144204-11-057406.txt : 20120106
<SEC-HEADER>0001144204-11-057406.hdr.sgml : 20120106
<ACCEPTANCE-DATETIME>20111011201918
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0001144204-11-057406
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20111011

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVELOS THERAPEUTICS, INC.
		CENTRAL INDEX KEY:			0001279704
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				043321804
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		ONE GATEWAY CENTER, SUITE 504
		CITY:			NEWTON
		STATE:			MA
		ZIP:			02458
		BUSINESS PHONE:		617-244-1616

	MAIL ADDRESS:	
		STREET 1:		ONE GATEWAY CENTER, SUITE 504
		CITY:			NEWTON
		STATE:			MA
		ZIP:			02458

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	COMMON HORIZONS INC
		DATE OF NAME CHANGE:	20040211
</SEC-HEADER>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Via EDGAR</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">October 11, 2011</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Mr. Jeffrey P. Riedler</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Assistant Director</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Division of Corporation Finance - Mail Stop 4720</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">United States Securities and Exchange Commission</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Washington, D.C. 20549</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt; TEXT-ALIGN: left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Re:&#160;</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt; TEXT-ALIGN: left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Novelos Therapeutics, Inc.</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font id="TAB1" style="MARGIN-LEFT: 72pt"></font>Registration Statement on Form S-1</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 72pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Initially Filed on July 1, 2011, amended by</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 72pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Amendment No. 1 to Registration Statement on Form S-1/A</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 72pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Filed August 15, 2011 and</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 72pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Amendment No. 2 to Registration Statement on Form S-1/A</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 72pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Filed September 14, 2011</font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font id="TAB1" style="MARGIN-LEFT: 72pt"></font>File Number 333-175284</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Dear Mr. Riedler:</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">This letter constitutes supplemental correspondence on behalf of Novelos Therapeutics, Inc., a Delaware corporation (the &#8220;Company&#8221;), related to the above-referenced filings (collectively, the &#8220;Registration Statement&#8221;).&#160;&#160;The purpose of this letter is to provide certain supplemental information requested by the Staff in comment number two of its letter dated September 28, 2011. The Company&#8217;s response to comment number one of the September 28<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">th</font> letter will be filed at a later date together with a third amendment to the Registration Statement, which will include an estimated price range. The Company&#8217;s response to comment number two is set forth below.&#160;&#160;For your convenience, we have repeated the Staff&#8217;s comment below in bold face type. Except as otherwise indicated, all statements contained herein concerning factual matters relating to the Company are based on information provided to us by the Company.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; TEXT-DECORATION: underline">Business</font></font></div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; TEXT-DECORATION: underline">Business of Novelos, page 27</font></font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">2. Your disclosure on page 28 indicates that the IND for LIGHT is held by Dr. Anne </font><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">Traynor at the University of Wisconsin, who both initiates and conducts the investigation and under whose immediate direction the investigational drug is administered. Please provide us supplemental documentation supporting:</font></div>

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<div align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic">The filing of the IND by Dr. Traynor, and</font></font></div>
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<div align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-STYLE: italic">Anything received from the FDA regarding the initial filing of the IND and its <font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">current status.</font></font></font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">The initial filing of the referenced IND (IND #67,287) was made by Dr. Joan Schiller of the University of Wisconsin (UW) in April 2003.&#160;&#160;She received approval to proceed with clinical investigations in May 2003.&#160;&#160;Dr. Schiller left UW during 2006, following which the IND was transferred to Dr. George Wilding, for an interim period, and then to Dr. Anne Traynor in November 2007.&#160;&#160;The Company has supplementally provided to the Staff the FDA correspondence documenting the initial filing by Dr. Schiller, the approval to proceed with clinical investigations, and the subsequent changes in sponsorship of the IND from Dr. Schiller ultimately to Dr. Traynor.&#160;&#160;Note that in 2005, the radioisotope used in the investigational compound was changed from iodine-131 to iodine-124.&#160;&#160;The compound currently covered by the IND (<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">124</font>I-NM404) is the same as the compound that the Company refers to as &#8220;LIGHT&#8221;.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">From 2003 through present, UW made a series submissions to the FDA under the IND including, among other things, changes to the clinical trial protocol, annual reports and other general correspondence.&#160;&#160;In October 2008, UW submitted an amendment to the clinical trial protocol in order to increase the dosage of the drug.&#160;&#160;The FDA responded with a request for additional information to which UW responded. There was then a series of communications between UW and the FDA from late 2008 through late 2010, during which time trial enrollment was suspended pending the resolution of the questions raised by the FDA. In October 2010, the study was put on full clinical hold pending the completion of certain chemistry, manufacturing and controls information and changes to the clinical trial protocol.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In June 2011, UW submitted a response to the outstanding clinical hold questions.&#160;&#160;At that time, the Company anticipated that enrollment in the clinical trials would commence in the third quarter of 2011.&#160;&#160;There was then further correspondence and information provided during the subsequent months as some questions were resolved and others required additional information.&#160;&#160;In July 2011, based on the status of the remaining questions, it was determined that the likely timing of commencement of enrollment would be the fourth quarter of 2011, rather than the third quarter of 2011.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">On October 4, 2011, a teleconference was held between the FDA and sponsor during which the remaining outstanding questions were resolved.&#160;&#160;On October 6, 2011, UW received a letter by electronic mail from the FDA confirming that the trial had been released from clinical hold. The Company has supplementally provided to the Staff a copy of the October 6, 2011 letter.&#160;&#160;UW currently plans to commence enrollment before the end of 2011.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Should the Staff have any additional comments or questions, please direct such to me at (617) 832-1113 or in my absence to Matthew Eckert at (617) 832-3057.</font></div>

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